Original Research

One-step conservative surgery vs hysterectomy for

placenta accreta spectrum: a feasibility randomized
controlled trial


Albaro Jose
Nieto-Calvache, MD; Rozi Aditya Aryananda, MD; Jose
Miguel Palacios-Jaraquemada, PhD;
Nareswari Cininta, MD; Ariani Grace, MD; Juan Pablo Benavides-Calvache, MD; Clara Ivette Campos, MD;
Adriana Messa-Bryon, MD; Liliana Vallecilla, MD; Daniela Sarria, MD; Juan Sebastian Galindo, MD;
Valentina Galindo-Velasco, MD; Luisa Fernanda Rivera-Torres, MD; Juan Manuel Burgos-Luna, MD;
Amarnath Bhide, MD, PhD, FRCOG

BACKGROUND: Placenta accreta spectrum is a serious condition [interquartile range, 1010−2410] vs 1500 mL [interquartile range, 1122
associated with significant maternal morbidity and even mortality. The rec- −2753]; odds ratio, 1 [1−1]; P=.942; median duration of surgery, 135
ommended treatment is hysterectomy. An alternative is 1-step conserva- minutes [interquartile range, 111−180] vs 155 minutes [interquartile range,
tive surgery, which involves the en bloc resection of the myometrium 120−185]; odds ratio, 0.99 [0.98−1]; P=.151; transfusion rate, 58.6% vs
affected by placenta accreta spectrum along with the placenta, followed 61.3%; odds ratio, 0.96 [0.83−1.76]; P=.768; and adverse event rate,
by uterine reconstruction. Currently, there are no studies comparing the 2 17.2% vs 9.7%; odds ratio, 1.77 [0.43−10.19]; P=.398; respectively). In
techniques in the setting of a randomized controlled trial. the subgroup of women with type 1 class on topographic classification, all
OBJECTIVE: We performed a prospectively registered multicenter participants allocated to 1-step surgery had successful outcomes, which
randomized controlled trial comparing hysterectomy with 1-step con- were superior to those of hysterectomy. This was evidenced by the shorter
servative surgery. The aim was to collect feasibility and clinical out- surgery duration (median, 125 [interquartile range, 98−128] vs 180 [129
comes of the 2 techniques in women assigned to hysterectomy or 1- −226] minutes; P=.002), lower transfusion rates (46.2% vs 82.4%), and
step conservative surgery. In addition to assessing participants’ will- fewer units of red blood cells transfused (median, 1 [interquartile range, 1
ingness to be randomized, we also collected data on intraoperative −1.8] vs 3 [interquartile range, 2−4] units; P=.007).
blood loss, transfusion requirement, serious adverse event, and other CONCLUSION: A randomized controlled trial comparing 2 surgical
clinical outcomes. techniques for the treatment of placenta accreta spectrum is feasible.
STUDY DESIGN: Sixty women with strong antenatal suspicion of pla- One-step conservative repair is a valid alternative to hysterectomy in the
centa accreta spectrum were assigned randomly to either hysterectomy large majority of cases, but this can only be ascertained following intrao-
(n=31) or 1-step conservative surgery (n=29). perative surgical staging.
RESULTS: During a 20-month period, 60 of the 64 eligible patients El resumen est
a disponible en Espa~nol al final del artículo.
(93.7%) underwent randomization. Intention-to-treat analysis showed that
the clinical outcomes for 1-step conservative surgery were comparable to Key words: accreta, randomized controlled trial, surgical technique,
those of hysterectomy (median intraoperative blood loss, 1740 mL uterine sparing surgery

Introduction EDITOR'S CHOICE placenta in situ for variable periods

until it is expelled vaginally)2 and differ-
T he incidence of placenta accreta
spectrum (PAS) has been increas-
ing in the last 20 years, generating sig-
or retrospective.2,3 Cesarean delivery
followed immediately by hysterectomy
ent uterine-sparing surgery techniques,
of which the best-described is one-step
nificant morbidity including massive is the most frequently used treatment conservative surgery (OSCS),9 which
bleeding, urinary tract injuries, and and has been considered the standard consists of “en bloc” resection of the
maternal death.1 There is no consensus of management,4 but it has not been placenta with the portion of myome-
on the ideal management of PAS, and compared with other types of treatment. trium affected by PAS, followed by
most evidence supporting a particular Although hysterectomy is a procedure reconstruction of the uterus.10 OSCS
surgical procedure is observational and/ known to all obstetricians, it is associ- has reported advantages over hysterec-
ated with considerable morbidity in the tomy, such as less surgical time, requir-
setting of PAS5 due to neovasculariza- ing a less extensive dissection, and

Aryananda RA,
Cite this article as: Nieto-Calvache AJ, tion and distortion of the pelvic preserving fertility in observational
Palacios-Jaraquemada JM, et al. One-step conservative anatomy. studies.11,12
surgery vs hysterectomy for placenta accreta spectrum: Personal, religious, and social beliefs PAS includes lesions that are very dif-
a feasibility randomized controlled trial. Am J Obstet
make it important for some patients ficult to manage, even for expert groups.
Gynecol MFM 2024;6:101333.
and families to avoid hysterectomy if Despite having ultrasound and intrao-
2589-9333/$36.00 other safe management options exist.6 perative characteristics identical to PAS,
© 2024 Elsevier Inc. All rights reserved. −8
Among the management alternatives some cases turn out to be myometrial
http://dx.doi.org/10.1016/j.ajogmf.2024.101333
are expectant management (leaving the dehiscence, in which the placenta

June 2024 AJOG MFM 1

Original Research

AJOG MFM at a Glance uterus, without evidence of neovascula-

rization between the uterus and the
Why was this study conducted? bladder, minimal scarring in the retro-
Placenta accreta spectrum is a serious condition and hysterectomy is the most vesical space, and spontaneous placental
common treatment. One-step conservative surgery has also been described, with expulsion after delivery of the infant.
no clear consensus on which surgical option is superior. There is no randomized No patients with uterine dehiscence
controlled trial comparing the 2 techniques. required hysterectomy, and all were
Key findings treated with OSCS.
One-step conservative surgery is a valid alternative to hysterectomy in most Photographs and videos of the ultra-
patients with placenta accreta spectrum. It is possible to individualize the man- sounds, surgery, and histologic analysis
agement following surgical staging. of the tissue resected in surgery (uterine
segment in case of OSCS or complete
What does this add to what is known? uterus in case of hysterectomy) were
Surgical staging allows the identification of patients eligible for 1-step conserva- collected and stored from all patients
tive surgery for placenta accreta spectrum. One-step conservative surgery may after obtaining informed consent in
yield outcomes comparable to those of hysterectomy, and provide an alternative each case.
to women wishing to preserve the uterus and/or fertility. The same initial surgical protocol was
applied to all patients, including surgi-
cal staging (Figure 2) and topographic
detaches spontaneously after the birth according to ultrasound.15 They were classification of PAS. After surgicalstag-
of the fetus.13 screened, and informed consent was staging, patients randomized to hyster-
To date, there have been no multi- obtained at least 24 hours before sur- ectomy received a hysterectomy after
center randomized controlled trials gery. Patients aged <18 years and those fetal extraction through an incision on
(RCT) comparing 2 surgical techniques with active vaginal bleeding, no placenta the anterior uterine wall above the
for the treatment of PAS, and some previa, and no previous live children upper edge of the abnormal myome-
authors consider that conducting them were excluded. One hour before sur- trium, whereas those randomized to
is challenging.14 gery, each patient was randomized to 1 OSCS underwent uterine-sparing sur-
We performed a feasibility study of of the 2 interventions (hysterectomy or gery (Figure 3) if they met the criteria
an RCT comparing hysterectomy with OSCS) (Figure 1). described for that intervention
OSCS. The aim was to collect feasibility (Figure 4).11 All surgical procedures
and clinical outcomes of the 2 techni- Randomization and blinding used in this study have been previously
ques in women randomly assigned Blinding of the intervention or of the described11,16−18 and are briefly sum-
to the 2 groups of hysterectomy and analysis of the data was not possible marized in Table 1.
OSCS. because certain variables made it evi-
dent to which group each participant Outcomes
Materials and Methods had been randomized. The randomiza- The primary objectives were the propor-
Study design tion sequence was generated in RED- tion of eligible patients who agreed to par-
This feasibility trial compared 2 surgical Cap (Vanderbilt University, Nashville, ticipate in the study, frequency of false
techniques for the management of PAS. TN) centralized at the Fundaci
on Valle positives, number of patients assigned to
The initial plan was to recruit partici- de Lili, Cali, Colombia. Permuted blocks each arm of the study, protocol violations,
pants from 3 hospitals (Fundaci
on of size 4 and 6, stratified by center, were and number of participants completing
Valle de Lili, Colombia; Dr. Soetomo used for randomization. follow-up at 42 days postpartum.
General Academic Hospital, Universitas We also collected information on
Airlangga, Surabaya, Indonesia; and Procedures intraoperative blood loss, transfusion
CEMIC University Hospital, Buenos At the time of laparotomy, intraopera- requirement, organ/urologic injuries,
Aires, Argentina). However, approval tive staging (Figure 2) was conducted as surgical reintervention, and maternal
from the ethics committee could not be described previously.16 Briefly, para- death. Fetal outcomes were also col-
obtained from the ethics committee of metrial and retrovesical spaces were lected.
CEMIC University Hospital, Buenos opened, thereby confirming or exclud- Data were stored in RedCap by the
Aires, Argentina. ing the presence of PAS and continued study monitor at each hospital. None of
participation in the study. Patients the researchers had access to the infor-
Participants without macroscopic signs of PAS at mation collected before the final data
Potential participants needed to have intraoperative staging were classified as analysis, which was conducted by the
risk factors (placenta previa in the cur- false positives. These patients had uter- general coordinator of the study and the
rent pregnancy with at least one prior ine dehiscence identified by a purplish statistical team at Fundaci
on Valle de
cesarean delivery) and suspected PAS4 bulge on the anterior surface of the Lili, Colombia.

2 AJOG MFM June 2024

 Original Research

FIGURE 1
CONSORT diagram

Randomization of patients in the feasibility study for a randomized controlled trial comparing hysterectomy with OSCS for PAS.
CONSORT, Consolidated Standards of Reporting Trials; OSCS, 1-step conservative surgery; PAS, placenta accreta spectrum.
Nieto-Calvache. One-step conservative surgery vs hysterectomy for placenta accreta spectrum. Am J Obstet Gynecol MFM 2024.

Sample size and statistical analysis and feasibility outcomes. The data are Ethics
No formal sample size calculation was presented as frequencies and percen- This study was approved by the ethics
performed in accordance with pub- tages for qualitative variables. Quantita- committees of Fundaci
on Valle de Lili
lished guidance for the conduct of feasi- tive variables are summarized using (Approval No. 10; May 19, 2021) and
bility studies.19 Based on the expected medians and interquartile ranges the Dr. Soetomo General Academic
number of cases at the recruiting cen- (IQRs). Statistical analysis was con- Hospital, Universitas Airlangga, Sura-
ters, a sample size of 60 was proposed, ducted following the principles of inten- baya (April 2022). The study was regis-
with a 1:1 allocation between treatment tion-to-treat. All data were analyzed tered at ClinicalTrials.gov on August
groups.20 The period foreseen for the using the statistical package Stata, ver- 19, 2021 (NCT05013749).
accumulation of the proposed cases was sion 14.0 (StataCorp, College Station,
18 months. TX). Results
Descriptive statistics are reported for Characteristics of the participants
demographic data, current pregnancy Funding Recruitment began in August 2021 in
clinical information, intraoperative This study did not receive any specific Colombia and in June 2022 in Indone-
details, placenta accreta−related factors, funding. sia, with the last participant recruited

June 2024 AJOG MFM 3

Original Research

FIGURE 2
Surgical staging

Surgical staging aims to visualize the lateral and anterior walls of the uterus before inducing bleeding. Well-described strategies in gynecologic oncologic
surgery are applied. A−C, The first step involves opening the parametrial space by A, tractioning the round ligament and cutting the loose peritoneum
medial to it. B, Subsequently, the surgeon introduces their fingers and creates an opening in the space vertically, C, exposing the lateral wall of the
uterus and displacing the vessels of the broad ligament laterally. D−F, The second step is the assessment of the retrovesical space by D, inserting both
index fingers into the previously opened parametrial spaces and E, moving them downward, reaching the medial paravesical space. F, Then, an attempt
is made to bring the tips of both fingers together in the midline to assess if the tissue is lax or if there is resistance to finger approximation, suggesting
vesicouterine fibrosis. G−I, The third step involves dissecting the retrovesical space G, with the aid of bladder traction using Allis clamps, H, identifying
and ligating vesicouterine pedicles one by one, I, to expose the anterior surface of the uterus. These 3 procedures can be performed before the infant’s
birth. Surgical staging is completed after fetal extraction by exteriorizing the uterus and evaluating its posterior wall.
Nieto-Calvache. One-step conservative surgery vs hysterectomy for placenta accreta spectrum. Am J Obstet Gynecol MFM 2024.

on April 17, 2023. During these periods, hysterectomy group received the Table 4 describes the clinical out-
82 patients with PAS were treated at the intended treatment after the diagnosis comes of the participants, with similar
2 hospitals; 76 of them were assessed of PAS was confirmed through surgical results in all variables between the 2
for eligibility, resulting in 64 eligible staging. The remaining 7 false-positive groups.
patients. Finally, 60 of them (93.7%) patients in that group were treated with Table 5 describes the clinical results
consented and were randomized OSCS. Table 2 describes the demo- of patients with lesions in the upper
(Figure 1), with 29 patients assigned to graphic characteristics of the partici- part of the anterior uterine wall (type 1
the OSCS group and 31 to the hysterec- pants. PAS on the topographic classification),
tomy group. After intraoperative stag- with lower blood loss, operating time,
ing, PAS could not be confirmed (false and frequency of transfusions among
positives) in 9 cases (patients with uter- Follow-up and outcomes patients undergoing OSCS (1540 mL
ine dehiscence and treated with OSCS). Postpartum follow-up at 6 weeks was [IQR, 970−1870], 125 minutes [IQR,
Of the 27 patients assigned to OSCS, completed in all included patients. 98−128], and 46.2%, respectively)
9 did not meet the criteria for uterine- Histologic confirmation of PAS was compared with the hysterectomy
sparing surgery (Figure 4) and under- obtained in all but 1 of the patients clas- group (1790 mL [IQR, 1410−2575],
went hysterectomy. Twenty-four of sified as having PAS after intraoperative 180 minutes [IQR, 129−226], and
the patients randomized to the staging (Table 3). 82.4%, respectively).

4 AJOG MFM June 2024

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FIGURE 3
One-step conservative surgery (OSCS) movements

After performing surgical staging and confirming that the criteria for performing OSCS are met (Figure 4), the fetus is extracted through A, a segmental
incision in the healthy myometrium above the placenta accreta spectrum (PAS) area. B, If there is placenta in that area, it is considered normally
implanted, and is C, managed using the Ward maneuver (https://doi.org/10.1016/s0029-7844(03)00625-2), which involves the surgeon’s hand being
inserted between the uterine wall and the placenta in a cephalic direction, performing a controlled separation of the normally inserted area. D, After
extracting the fetus, the uterus is exteriorized, and bleeding from the edges of the hysterotomy is controlled using Foerster clamps. E, Surgical staging is
completed by excluding involvement of the posterior wall of the uterus, and the colpouterine pedicles ascending toward the PAS area from the vagina
are ligated, at the midline (6 o’clock) and on each side (3 and 9 o’clock). F, Subsequently, the myometrium affected by PAS is excised, cutting above
the colpouterine ligatures, and G, the portion of the myometrium affected by PAS is removed en bloc with the placenta. Uterine reconstruction is then
performed with 2 layers of suture using polyglactin 910: H, the first layer with “U” stitches at the midline and on each side, and I, the second layer with
continuous, nonlocking, invaginating suture.
Nieto-Calvache. One-step conservative surgery vs hysterectomy for placenta accreta spectrum. Am J Obstet Gynecol MFM 2024.

Difficulties observed during the plan- detected on postoperative day 21 and Comment
ning and execution of this study are will need surgical repair. Five of the 8 Principal findings
described in Table 6. women with adverse events were ran- OSCS is successful in two-thirds of
domized to OSCS, but in 4 of them cases of PAS where the choice of the
Safety intraoperative staging led to an imme- treatment modality is determined by
There were no maternal deaths. Eight diate crossover to hysterectomy, and randomization. It is not possible to
cases of adverse events were docu- OSCS was not attempted. Only 1 make a definitive diagnosis of PAS or to
mented (Table 4), with 6 of them patient randomized to OSCS, and who predict the success of treatment modal-
related to massive intraoperative finally received that treatment, had ity until intraoperative staging has been
bleeding. One patient experienced car- bleeding >2 L due to a laceration of conducted. The clinical outcomes are
diac arrest, but was resuscitated suc- an arterial vessel over the broad liga- largely comparable between OSCS and
cessfully. In addition, there was a case ment at the beginning of surgery hysterectomy.
of partial intestinal obstruction that (Supplemental Material). One fetal We have demonstrated that women
required readmission 12 days after demise before surgery and without with suspected PAS are willing to par-
surgery, with spontaneous resolution. identified cause was observed in the ticipate in a study where hysterectomy
One case of vesicovaginal fistula was OSCS group. or OSCS is assigned by a process of

June 2024 AJOG MFM 5

Original Research

FIGURE 4 ascribed to operator judgment.26,27 The

Criteria for 1-step conservative surgery (OSCS) analysis of the results is complex when
an attempt to preserve the uterus is
made in participants with lesions with
dense uterovesical adhesions that are
complicated by significant neovasculari-
zation. Such attempts are often unsuc-
cessful, ending in a hysterectomy,
which is associated with additional
blood loss.25,27

Clinical implications
This study shows that candidates for
hysterectomy or uterine-sparing surgery
can be selected only after intraoperative
staging. Only 1 of the 8 adverse events
(Table 4) occurred in a patient undergo-
ing OSCS and was related to attempts to
preserve the uterus in a woman with
abnormality in the lower anterior uterine
wall (PAS type 3 on the topographic
classification), with a surgical error at the
beginning of the surgery. Criteria for
The following 3 requirements must be checked for each patient to determine if they are candidates
considering a patient as a candidate for
for OSCS: (1) the bladder can be separated from the uterus (without vesicouterine fibrosis); (2) there
OSCS have been clearly described previ-
is at least 2 cm of healthy myometrium above the cervix (caudal to the area of abnormal placental
ously (Figure 4),11 and the skills neces-
migration); and (3) the size of the affected myometrium is <50% of the axial circumference of the
sary to perform intraoperative staging
uterus. A and B, The boundary between the healthy myometrium (whiter and firmer) and the hyper-
are not different from those required to
vascularized area of purple bulging is indicated with the forceps. More than 2 cm of healthy caudal
perform any type of surgery for PAS.
myometrium is evident on the A, right and B, left sides of the uterus. C and D, The lateral and poste-
Post hoc analysis shows that OSCS could
rior views of the uterus confirm involvement of <50% of the uterine circumference by placenta
be performed successfully in all patients
accreta spectrum (PAS). The lateral limit of the area affected by PAS is marked with the tip of the
classified as type 1 PAS (lesions superior
forceps. In all photos, the anterior wall of the uterus is fully visible, and the bladder has been sepa-
to the bladder peritoneal reflection, in
rated from the uterus during surgical staging. In the bulging area, dark suture threads are visible
the anterior uterine wall) during intrao-
where the vesicouterine pedicles connecting the PAS area to the posterior wall of the bladder were
perative staging (Table 5) in whom uter-
ligated.
ine-sparing surgery seems to have better
Nieto-Calvache. One-step conservative surgery vs hysterectomy for placenta accreta spectrum. Am J Obstet Gynecol MFM
2024. results than hysterectomy. Previous
studies show that approximately 80% of
patients with PAS can be managed with
OSCS when performed by experienced
randomization. The cohort was at high planning and execution of this study practitioners.10,11,28 The psychological
risk of PAS, as demonstrated by the (Table 6) similar to those experienced and social impact of hysterectomy must
high ascertainment rate at intraopera- previously.14,21−23 Indeed, the fre- be considered when introducing options
tive staging (51/60) and histopathologic quency of recruitment to an RCT may in the therapeutic repertoire of a PAS
confirmation (50/60). However, even in be lower in other populations and the team.8 It should also be noted that a sig-
a cohort with high-risk features identi- factors to take into account are multi- nificant number of women with PAS
fied from medical history and ultra- ple.24 Previous studies comparing hys- wish to become pregnant again. In this
sound findings, false positives were still terectomy with uterine-sparing surgery series, 3 patients declined to participate
possible. had a retrospective design,25 with no because they strongly desired another
clear case selection criteria. It could be pregnancy, and 1 patient was excluded
Results in the context of what is argued that OSCS was chosen in less because she had no previous living chil-
known severe cases, which could explain why dren (Figure 1).
The results of this study have several OSCS was feasible in the large majority
implications. Ninety-three percent of of PAS cases and had clinical outcomes Research implications
eligible patients agreed to participate in comparable to those of hysterectomy. In this feasibility study, the sample size
this study despite difficulties during the The choice of treatment is generally was calculated following previously

6 AJOG MFM June 2024

 Original Research

TABLE 1
Surgical procedures and information recording practices used in this study
Surgical staging: Preferring a wide transverse incision in the skin and vertical in the fascia, the opening of the parametrial space was performed by
cutting the peritoneum medial to the broad ligament and widening the incision digitally. Subsequently, the retrovesical space was evaluated by
passing both index fingers from lateral to medial, starting in the medial paravesical space, and evaluating the resistance of the tissues in search of
fibrosis between the uterus and bladder (retrovesical bypass or “Pelosi maneuver”). Next, with the help of anterocaudal traction of the bladder
with Allis forceps, the retrovesical space was dissected, ligating the identified vesicouterine vascular pedicles one by one. These 3 initial steps
were performed in all patients before fetal extraction, allowing evaluation of the lateral and anterior walls of the uterus. Intraoperative staging was
completed after fetal extraction by externalizing the uterus from the abdominal cavity through direct visualization of the posterior uterine wall
(Figure 2).
Intraoperative confirmation of PAS: From the moment of laparotomy and after exposing the anterior and lateral uterine walls, surgeons looked for
macroscopic signs of PAS on the external surface of the uterus on the area of placental implantation. The criteria described by FIGO (https://doi.
org/10.1002/ijgo.12761) and IS-PAS (https://doi.org/10.1016/j.ajog.2019.02.054) were used: “bluish/purple colouring, distension (placental
‘bulge’)” and “Significant amounts of hypervascularity (dense tangled bed of vessels or multiple vessels running parallel craniocaudally in the
uterine serosa).”
No clear criteria have been published to differentiate PAS from dehiscence. The final differentiation between PAS and dehiscence is determined by
whether the placenta is separated after fetal extraction. In this study, confirmation of the diagnosis of PAS had to be made before fetal extraction.
Patients with uterine dehiscence randomized to hysterectomy had to be reassigned to the OSCS arm and were classified as “false positives” of
the prenatal diagnosis. For this reason, we use the absence of vesicouterine arterial pedicles (abnormal vessels running between the uterus and
the bladder) as a differential criterion. The absence of these vessels makes vesicouterine dissection extremely easy in dehiscense cases, unlike
PAS cases, in which it is necessary to ligate multiple vesicouterine pedicles. Photographs and videos of intraoperative findings were stored.
One-step conservative surgery: After intraoperative staging, presence of 3 criteria to perform OSCS (the bladder can be separated from the uterus,
at least 2 cm of healthy myometrium caudal to the PAS area on the anterior uterine wall, and >50% of the uterine circumference free of PAS) was
evaluated (Figure 4). If the patient met these parameters, fetal extraction was performed (through an incision on the healthy myometrium,
immediately above the PAS area) and subsequently “en bloc” resection of the abnormal uterine segment with the attached placenta. Before the
“en bloc” resection, the colpouterine pedicles were ligated at 3, 6, and 9 o’clock. Finally, the edges of the hysterotomy were sutured with 2 layers
of absorbable suture (Figure 3).
Hysterectomy: After intraoperative staging, fetal extraction was performed while avoiding the PAS area, followed by clamping of the hysterotomy
edges for bleeding control or single-plane hysterorrhaphy. Clamping, cutting, and ligation of both broad ligaments were performed sequentially
from their cephalic portion (individualizing first the broad ligament and then the uterine-ovarian ligament) to the most caudal part at the level of the
vaginal vault. If vesicouterine fibrosis was found with the impossibility of separating the uterus from the bladder (type 4 PAS on the topographic
classification), a modified subtotal hysterectomy was performed with the previously described technique (https://doi.org/10.1080/
14767058.2023.2183741) including compressive sutures of the uterine stump and cervix.
Topographic classification of PAS: This classification takes into account the location of the abnormality in the uterus (which uterine wall is affected:
anterior, lateral, or posterior), the relationship of the area affected by PAS with the vesicouterine peritoneal reflection (above or below the
reflection), and the presence or absence of fibrosis between the uterus and the bladder.
Type 0 refers to uterine dehiscence.
Type 1 refers to injuries of the upper part of the anterior uterine wall.
Type 2 refers to lesions of the lateral wall of the uterus.
Type 3 refers to injuries of the lower part of the anterior uterine wall.
Type 4 has the same topography as type 3, but is accompanied by vesicouterine fibrosis that makes it impossible to separate the uterus from the
bladder in surgery.
Type 5 corresponds to lesions of the posterior wall of the uterus.
Bleeding quantification: The quantification of the bleeding volume was conducted by adding the weight of the blood-soaked surgical clothing (from
which the dry weight of the clothing was subtracted), the contents of the suction device (subtracting the volume corresponding to amniotic fluid),
and the contents of graduated blood collection bag placed under the patient’s pelvis.
Data recording: The surgeons used an operative note format that specified all the variables that they should collect immediately upon completion of
the surgery. The study monitor at each hospital supervised that the surgeons deposited all the information in the surgical note and extracted that
information from the medical records to enter it on the same day of surgery in the RedCap database.
Photo and video capture: The LogicalDOC platform was used to store photographs and videos of the ultrasound (including transabdominal and
transvaginal routes), surgery (including the 3 steps of intraoperative staging and the most important steps of OSCS and hysterectomy), and the
analysis by the pathology service (images of the macroscopic and microscopic analysis of the surgical specimen). Informed consent was obtained
from all patients for taking photographs and videos during surgery.
FIGO, International Federation of Gynecology and Obstetrics; IS-PAS, International Society for Placenta Accreta Spectrum; OSCS, 1-step conservative
surgery; PAS, placenta accreta spectrum.
Nieto-Calvache. One-step conservative surgery vs hysterectomy for placenta accreta spectrum. Am J Obstet Gynecol MFM 2024.

June 2024 AJOG MFM 7

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TABLE 2
Demographic and presurgical characteristics of patients with prenatal suspicion of placenta accreta spectrum
Group n (%)
Total Hysterectomy OSCS
Variable (n=60) (n=31) (n=29)
Maternal age (y)a 33.28 (4.38) 33.13 (4.26) 33.45 (4.56)
Body mass index 18−24 18 (30.0%) 10 (32.3%) 8 (27.6%)
25−29 25 (41.7%) 13 (41.9%) 12 (41.4%)
≥30 17 (28.3%) 8 (25.8%) 9 (31.0%)
Number of previous pregnancies 1 16 (26.7%) 9 (29.0%) 7 (24.1%)
2 24 (40.0%) 16 (51.6%) 8 (27.6%)
≥3 20 (33.3%) 6 (19.4%) 14 (48.3%)
Number of previous cesarean deliveries 1 32 (53.3%) 18 (58.1%) 14 (48.3%)
2 26 (43.3%) 13 (41.9%) 13 (44.8%)
≥3 2 (3.3%) 0 2 (6.9%)
Number of previous dilatation and curettage 0 45 (75.0%) 24 (77.4%) 21 (72.4%)
1 12 (20.0%) 7 (22.6%) 5 (17.2%)
≥2 3 (5.0%) 0 3 (10.3)
b
Gestational age at the time of diagnosis of PAS 32.75 (30.00−34.10) 33.10 (31.50−34.70) 31.00 (26.20−33.00)
Diagnostic method of PAS Ultrasound 46 (76.7%) 25 (80.6%) 21 (72.4%)
Ultrasound and 14 (23.3%) 6 (19.4%) 8 (27.6%)
magnetic resonance
Antepartum vaginal bleeding 1 (1.7%) 1 (3.2%) 0
Comorbidity Hypertensive disorder 2 (3.3%) 1 (3.2%) 1 (3.4%)
Gestational diabetes 1 (1.7%) 0 1 (3.4%)
b
Gestational age at birth (wk) 35.00 (34.00−36.00) 35.00 (34.00−36.00) 35.00 (34.00−36.00)
OSCS, 1-step conservative surgery; PAS, placenta accreta spectrum.
a
Mean (standard deviation); b Median (interquartile range).
Nieto-Calvache. One-step conservative surgery vs hysterectomy for placenta accreta spectrum. Am J Obstet Gynecol MFM 2024.

published methodological recommen- size, but could also yield clinically irrele- Another possible outcome measure is
dations20 and was not sufficiently pow- vant results. Given that the diagnosis of blood loss. The difference in median
ered to determine differences in clinical PAS is not confirmed in approximately blood loss between the 2 groups was
results between OSCS and hysterectomy one-eighth of women, the true fre- 240 mL. This constitutes 14% of the
for treating PAS. Observation of clinical quency of morbidity in suspected PAS median blood loss. These small differ-
outcomes in a randomized trial of feasi- cases is lower than that observed in ences in the substantive clinical out-
bility serves 2 purposes. Firstly, it allows those where the diagnosis is confirmed. comes in the 2 groups bring into
for commentary on whether the Moreover, given that 1 in 3 women question the feasibility, necessity, and
observed difference holds any clinical scheduled for an OSCS need a hysterec- prudence of a larger RCT comparing
significance, and consequently, whether tomy after intraoperative staging, the hysterectomy and OSCS for the man-
a confirmatory trial would be poten- maximum theoretical reduction in mor- agement of this difficult disease.
tially beneficial. Secondly, if the bidity in the OSCS group is two-thirds.
observed difference is clinically signifi- The estimated sample size to demon- Strengths and limitations
cant, it can be used to estimate the sam- strate a reduction of bladder injury This study is subject to the limitations
ple size with adequate statistical power. from 5% to 1% would be 842 partici- inherent to feasibility studies. The scope
Injury to the urinary bladder was pants (Fleiss formula). This small differ- of our conclusions is restricted because
reported in 3 women (5%). Any future ence might override patient preferences of the sample size, which was deter-
study powered on this outcome would in the decision-making process for the mined with the aim of uncovering pre-
not only require a very large sample final treatment modality. viously unknown details to plan a

8 AJOG MFM June 2024

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TABLE 3
Results related to feasibility
Group n (%)
Total Hysterectomy OSCS
Variable N=60 n=31 n=29 Significance
a
False positive 9 (15%) 7 (22.6%) 2 (6.9%) .15
Surgical intervention changed after randomization b
16 (26.7%) 7 (22.6%) 9 (31.0%) >.9
Participants completing follow-up at 42 d postpartum 60 (100%) 31 (100%) 29 (100%) >.9
Histology diagnosis Accreta 8 (13.3%) 3 (9.7%) 5 (17.2%) .9
Increta 40 (66.7%) 19 (61.3%) 21 (72.4%)
Percreta 2 (3.3%) 1 (3.2%) 1 (3.5%)
No accreta 10 (16.7%) 8 (25.8%) 2 (6.9%)
PAS topographic classificationc Type 0 9 (15%) 7 (22.6%) 2 (6.9%) .2
Type 1 30 (50%) 17 (54.8%) 13 (44.8%)
Type 2 4 (6.7%) 2 (6.5%) 2 (6.9%)
Type 3 8 (13.3%) 2 (6.5%) 6 (2.7%)
Type 4 9 (15%) 3 (9.7%) 6 (2.7%)
Type 5 0 0 0
d
PAS FIGO clinical classification No PAS 9 (15%) 7 (22.6%) 2 (6.9%) .2
Grade 1 3 (5%) 1 (3.2%) 2 (6.9%)
Grade 2 38 (63.3%) 20 (64.5%) 18 (62.1%)
Grade 3A 3 (5%) 0 3 (10.4%)
Grade 3B 6 (10%) 3 (9.7%) 3 (10.3%)
Grade 3C 1 (1.7%) 0 1 (3.4%)
The description of the included population (n=60) according to different variables may seem repetitive, but is done intentionally so that readers can identify their distribution according to different PAS
classifications (“histology diagnosis,” “topographic classification,” and “FIGO clinical classification”).
Patients with false positive prenatal diagnosis all had uterine dehiscence and correspond to “Type 0” (topographic classification) or “No PAS” (line added to the FIGO classification). These patients are
included in the “No accreta” line of the “histology diagnosis” variable where there is also 1 patient with clinical criteria of PAS after hysterectomy, but without histologic confirmation.
FIGO, International Federation of Gynecology and Obstetrics; OSCS, 1-step conservative surgery; PAS, placenta accreta spectrum.
a
Patients without gross signs of PAS at intraoperative staging. These patients were classified as false positives of the prenatal diagnosis and were women with uterine dehiscence. All were treated
with OSCS; b All patients had been randomized before surgery to a certain procedure; however, after performing intraoperative staging, it was identified that some women did not have signs of PAS (7
patients with false positive prenatal diagnosis, randomized to hysterectomy), so they were managed with OSCS, and that some women did not meet the criteria to perform OSCS (9 patients randomized
to OSCS), so they were managed with hysterectomy; c Classification based on the affected uterine wall: type 0: uterine dehiscence, not PAS; type 1: upper anterior lesion; type 2: lateral (parametrial)
lesion; type 3: lower anterior lesion; type 4: lower anterior lesion plus vesicouterine fibrosis; type 5: posterior lesion; d Classification considering clinical signs during laparotomy. Appearance of the
anterior aspect of the uterus. FIGO classification does not include a category for patients without PAS. Thus, we included a “No PAS” line in which patients with “false positive” diagnosis are described
to avoid confusion regarding the total number of patients.
Nieto-Calvache. One-step conservative surgery vs hysterectomy for placenta accreta spectrum. Am J Obstet Gynecol MFM 2024.

future RCT in patients with PAS. included, who were affected by type 1 sample size. However, this study is
Nevertheless, this study provided valu- PAS on the topographic classification among the larger series reported with
able insights by directly comparing 2 (Table 5). prospective methodology, and it pro-
surgical techniques for PAS using an The evaluation of psychological vides a direct comparison of 2 surgical
experimental design. Beyond providing aspects related to the removal or conser- techniques for PAS.
essential information for planning and vation of the uterus, to future fertility in The results of this study also raise
executing an RCT, this study shows that patients undergoing OSCS, or to quality additional questions. Is it correct to
OSCS is possible and suggests that its of life after extensive pelvic surgery is compare 2 surgical techniques applied
results are comparable to those of hys- beyond the scope of this study. Another as standard treatment to such a hetero-
terectomy (when analyzing all patients limitation of this study is that rare but geneous population with different clini-
with PAS) or even better than hysterec- very serious adverse events may not cal presentations? Our results clearly
tomy, as observed in 50% of patients have been captured because of the small indicate that there are PAS patients for

June 2024 AJOG MFM 9

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TABLE 4
Clinical results of placenta accreta spectrum patients taken for surgical management
Group n (%)
Total Hysterectomy OSCS
Variable (n=60)a (n=31) (n=29) OR (95% CI; P value)
b
Intraoperative bleeding volume (mL) 1675 (1078−2504) 1500 (1122−2753) 1740 (1010−2410) 1.00 (1.00−1.00; P=.942)
b
Length of surgery (min) 144.00 (117.00−180.00) 155.00 (120.00−185.00) 135.00 (111.00−180.00) 0.99 (0.98−1.00; P=.151)
Length of hospitalization (d)c 4 (3−6) 4 (3.5−5) 5 (3−6) 1.05 (0.81−1.36; P=.731)
RBCU transfusion 36 (60.0) 19 (61.3) 17 (58.6) 0.96 (0.83−1.76; P=.768)d
Number of RBCU transfusedb 3 (1−4) 3 (2.5−4) 2 (1−4) 0.92 (0.62−1.31; P=.658)
>4 RBCU transfused 12 (20.0) 7 (22.6) 5 (17.2) —
Bladder injury 3 (5.0) 2 (6.5) 1 (3.4) 0.52 (0.02−5.70; P=.599)
Surgical reintervention 2 (3.3) 1 (3.2) 1 (3.4) 1.07 (0.04−27.97; P=.962)
Admission to intensive care unit 7 (11.7) 4 (12.9) 3 (10.3) 0.78 (0.14−3.86; P=.758)
Type of anesthesia Neuraxial 13 (21.7) 7 (22.6) 6 (20.7) —
General 44 (73.3) 23 (74.2) 21 (72.4) 1.02 (0.25−3.54; P=.938)
Neuraxial with 3 (5.0) 1 (3.2) 2 (6.9) 2.15 (0.15−50.23; P=.609)
conversion to
general
Skin incision Vertical 22 (36.7) 11 (35.5) 11 (37.9) —
Transverse 38 (63.3) 20 (64.5) 18 (62.1) 1.06 (0.39−3.54; P=.780)
Vascular interventions None 47 (78.3) 27 (87.1) 20 (68.9) —
IMAC 1 (1.7) 0 1 (3.5) NA
REBOA 2 (3.3) 2 (6.5) 0 NA
Aortic cross-clamping 10 (16.7) 2 (6.5) 8 (27.6) 4.24 (1.11−36.73; P=.055)
e
Adverse event 8 (13.3) 3 (9.7) 5 (17.2) 1.77 (0.43−10.19; P=.398)d
d
Statistical tests of significance are not recommended for the clinical outcomes of feasibility trials. We calculated the ORs, focusing on 2 possible primary outcomes for a future superiority trial.
CI, confidence interval; IMAC, internal manual aortic compression; NA, not applicable; OR, odds ratio; OSCS, 1-step conservative surgery; RBCU, red blood cell units; REBOA, resuscitative endovascu-
lar balloon occlusion of the aorta.
a
Patients classified as false positive were excluded (those without macroscopic signs of placenta accreta spectrum at laparotomy, after intraoperative staging); b Median (interquartile range); c After
surgery; d Two possible primary outcomes for a future superiority trial; e Bleeding >2.5 L or other situation that prolonged hospitalization, motivated reoperation or rehospitalization, or put life at risk.
Nieto-Calvache. One-step conservative surgery vs hysterectomy for placenta accreta spectrum. Am J Obstet Gynecol MFM 2024.

TABLE 5
Clinical results of type 1 placenta accreta spectrum patients (lesion in the upper anterior uterine wall)
Group n (%)
Total Hysterectomy OSCS
Variable (n=30) (n=17) (n=13) Significance
Intraoperative bleeding volume (mL)a 1675 (1290−2159) 1790 (1410−2575) 1540 (970−1870) .2
Length of surgery (min)a 132 (120−180) 180 (129−226) 125 (98−128) .002
RBCU transfusion 20 (66.7) 14 (82.4) 6 (46.2) .007
a
Number of RBCU transfused 2.5 (1−3.2) 3 (2−4) 1 (1−1.8)
>4 RBCU transfused 0 0 0 —
Bladder injury 0 0 0 —

(continued)

10 AJOG MFM June 2024

 Original Research

TABLE 5
Clinical results of type 1 placenta accreta spectrum patients (lesion in the upper anterior uterine wall) (continued)
Group n (%)
Total Hysterectomy OSCS
Variable (n=30) (n=17) (n=13) Significance
Surgical intervention has finally changed after randomization 0 0 0 —
Surgical reintervention 0 0 0 —
Admission to intensive care unit 2 (6.7) 2 (11.8) 0 —
Type of anesthesia Neuraxial 3 (10) 0 3 (23.1) .026
General 26 (86.7) 17 (100) 9 (69.2)
Neuraxial with conversion to general 1 (3.3) 0 1 (7.7)
Skin incision Vertical 9 (30) 8 (47.1) 1 (7.7) .042
Transverse 21 (70) 9 (52.9) 12 (92.3)
Vascular interventions None 30 (100) 17 (100) 13 (100) >.9
Surgical intervention has finally changed after randomization 0 0 0 —
Histology diagnosis Accreta 1 (3.3) 0 (0) 1 (7.7) .7
Increta 27 (90) 16 (94.1) 11 (84.6)
Percreta 2 (6.7) 1 (5.9) 1 (7.7)
No accreta 0 0 0
PAS FIGO clinical classification Grade 1 2 (6.7) 0 (0) 2 (15.4) .2
Grade 2 28 (93.3) 17 (100) 11 (84.6)
Grade 3A 0 0 0 —
Grade 3B 0 0 0 —
Grade 3C 0 0 0 —
Adverse event 0 0 0 —
FIGO, International Federation of Gynecology and Obstetrics; OSCS, 1-step conservative surgery; PAS, placenta accreta spectrum; RBCU, red blood cell units.
a
Median (interquartile range).
Nieto-Calvache. One-step conservative surgery vs hysterectomy for placenta accreta spectrum. Am J Obstet Gynecol MFM 2024.

TABLE 6
Difficulties observed during the implementation of the randomized controlled trial comparing 2 surgical techniques
for placenta accreta spectrum
Identified difficulty Description of the problem How do we deal with this difficulty in this study?
How to select the Diagnosing PAS by ultrasound and by the We chose a pragmatic approach, such as that used by
candidate to be appearance of the uterus at laparotomy is professionals in practice subjecting women with
randomized? inaccurate. prenatal suspicion of PAS to protocolized surgical
management.
We increased the positive predictive value of prenatal
imaging by including only patients with previous
cesarean delivery and placenta previa.
Diagnosis confirmation through surgical staging.
Supervision of included patients through photographic and
video recording evaluation of the surgeries performed.
When to randomize? Intraoperative randomization allows for surgeon Randomize before laparotomy to avoid selection bias.
bias. Checking inclusion criteria after laparotomy and surgical
Randomizing well before surgery allows some staging.
randomized patients to escape study supervision

(continued)

June 2024 AJOG MFM 11

Original Research

TABLE 6
Difficulties observed during the implementation of the randomized controlled trial comparing 2 surgical techniques
for placenta accreta spectrum (continued)
Identified difficulty Description of the problem How do we deal with this difficulty in this study?
if they have surgery at another hospital or if they
have emergency surgery.
When to obtain informed Obtaining patient’s informed consent long before Considering that in LMIC, it is common for PAS patients to
consent from patients? surgery allows for potential changes in their be identified late or lost to follow-up, and daily surgical
clinical condition, which could render them schedules may be altered because of other urgent cases
ineligible. Obtaining consent shortly before (with insufficient operating room availability), we
surgery might not provide them with sufficient decided to provide a comprehensive overview of the
time to ask questions or adequately contemplate various surgical options available at the time of
their response. diagnosing PAS and scheduling surgery. Patients
desiring more children, expressing doubts, or refusing to
participate were excluded. Patients expressing an
intention to participate signed their informed consent
1 hour before surgery, allowing sufficient time for
thoughtful decision-making. This strategy was approved
by our ethics committee.
How to objectively Visual estimation of bleeding is inaccurate. An objective blood measurement protocol was established
measure intraoperative The calculation of blood loss by evaluating changes with the following 3 components: weight of blood-
bleeding? in hemoglobin levels is inaccurate. soaked clothing, evaluation of the content of suction
The volume of amniotic fluid lost can alter the devices, and content of the vaginal blood collection bag.
quantification of bleeding in suction devices. Graduated collection bags were distributed for the
Not all hospitals usually weigh surgical pads. quantification of vaginal bleeding.
Not all hospitals use graduated blood collection
bag placed under the patient’s pelvis.
How to ensure that the The validity of any classification depends on the Supervision of included patients through photographic and
topographic judgments of the person who applies it. video recording evaluation of the surgeries performed.
classification is applied It is possible that the results of the study are
correctly? affected by the surgeon reporting a different
category than the one the patient presents.
Is it ethical in a hospital In hospitals where uterine-conserving surgery is A discussion session was held with all participants.
used to perform OSCS routinely performed, it may be controversial to We reviewed the available evidence supporting the use of
to propose subject a patient candidate for uterine sparing OSCS and hysterectomy, finding that in the absence of
hysterectomy to surgery to a hysterectomy. previous RCTs (or previous feasibility trials), the
patients? In one of the hospitals that initially wanted to be evidence was limited to case studies, retrospective
included (Buenos Aires, Argentina), approval cohorts, and expert opinion.
from the ethics committee was finally not The potential positive impact on patients in other hospitals
obtained because most patients who consulted was evaluated, if a benefit with OSCS was proven.
there did so for the option of uterine sparing Multiple hospitals were invited to participate in this study.
surgery. After registration of the research protocol in www.
clinicaltrials.gov, the project was disseminated in
several international scientific activities. Although there
are several centers that routinely apply uterine-sparing
surgery (Egypt, Vietnam, Israel, Ireland, Nicaragua,
Bolivia, Taiwan), it was not possible to coordinate the
participation of other centers, and the calculated sample
size (n=60) was achieved with the participation of 2
hospitals in 20 months.
If in this feasibility study If, among the results of this feasibility trial, we find This may be a discussion to address in the future, but it is
we find that OSCS is at that OSCS is feasible in most patients possible that this feasibility study alone could be
least equivalent to randomized to that treatment, the frequency of sufficient to validate OSCS as a treatment option for
hysterectomy, would it complications is similar between the 2 groups, PAS. Currently, OSCS is mentioned in international
be ethical to and the clinical outcomes are comparable, it guidelines as a procedure applicable to a minority of
subsequently conduct a would be ethical in the future to conduct a formal patients, in a few hospitals.
formal RCT? RCT knowing that OSCS offers the advantage of
preserving fertility or at least conserving the
uterus (some women prefer to keep their uterus
even if they do not desire future pregnancies).

(continued)

12 AJOG MFM June 2024

 Original Research

TABLE 6
Difficulties observed during the implementation of the randomized controlled trial comparing 2 surgical techniques
for placenta accreta spectrum (continued)
Identified difficulty Description of the problem How do we deal with this difficulty in this study?
Is an intention-to-treat If an OSCS candidate ultimately receives In the current situation of low frequency of use of OSCS,
analysis appropriate? hysterectomy, intention-to-treat analysis can the priority is to demonstrate that this procedure is
negatively affect OSCS results. possible and safe.
If the results suggest benefit, in the presence of
confounding factors, the potential benefit may be
greater.
How to handle unequal Different hospitals have different influx of patients A differential contribution was established, with 50% of
patient contributions in with PAS. The unequal contribution of patients patients coming from the hospital with the highest
different hospitals with from participating hospitals may influence the volume and 25% from each of the hospitals with the
different patient flow? results of a multicenter study. lowest volume.
In the end of this study, only 2 hospitals participated, and
patients were enrolled until the sample of 60 women
was complete, with greater contribution from one of the
hospitals.
It is recommended to include several hospitals to dilute
the effect that a hospital with a high patient flow can
have in multicenter studies.
How to manage the time One of the hospitals took a year to obtain approval. The planned preparation period (before patient
needed to obtain Another hospital never obtained approval and could recruitment) for an RCT must consider enough time for
approvals at each not include patients. internal authorization procedures in each center.
hospital? It is possible to begin recruitment in hospitals with low
patient flow by allowing a longer inclusion window for
patient admission before approvals are obtained in
hospitals with high patient flow.
How to perform blinding? Impossible to mask during the execution of the Blinded observers should be used for evaluating
surgical procedure. outcomes.
How to decide which Participating hospitals must correctly perform the Interventions to be compared must be clearly defined and
hospitals can surgical technique to be evaluated. the participating hospitals must perform both
participate? There are many published modifications for OSCS. procedures according to the study protocol.
During the enrollment period for this study, the Inclusion of hospitals that master the different PAS
detailed protocol was published in clinical trials, management options.
and hospitals with a high flow of patients with Inclusion of hospitals with a high flow of patients.
PAS were invited to participate through social Establish surgical technique standardization programs to
networks and through direct emails. Only 3 which the participating hospitals adhere.
hospitals were interested and approval from the Quality control of surgical intervention.
ethics committee was only obtained in 2 of them.
How to handle hospitals Few hospitals routinely implement OSCS, with Publication of case series applying conservative surgical
interested in most of them located in LMIC. Conducting a techniques in PAS is becoming increasingly common.
participating that do multicenter study becomes challenging when Most of these involve modifications to OSCS.
not yet master OSCS? only a limited number of hospitals use the Training experienced surgeons in performing OSCS, who
technique under evaluation. are already proficient in hysterectomy for PAS, is not
complex. Proper patient selection for this technique
using intraoperative staging and remote virtual
supervision has shown positive results.
Learning new surgical techniques is an integral part of the
necessary continuous improvement in any reference
center for PAS.
How to manage the Some surgical protocols require the use of Use of surgical protocol focused on procedures achievable
variability of resources expensive technology that is not available in all in hospitals with limited resources.
available in different hospitals. Inclusive and pragmatic or experience-based design.
hospitals?

(continued)

June 2024 AJOG MFM 13

Original Research

TABLE 6
Difficulties observed during the implementation of the randomized controlled trial comparing 2 surgical techniques
for placenta accreta spectrum (continued)
Identified difficulty Description of the problem How do we deal with this difficulty in this study?
How to stimulate the Structural, cultural, and psychological resistance Week-by-week support/contact with each participating
recruitment of patients exists to the use of randomization, especially hospital.
in participating during emergent surgeries. Clear authorship policy with encouragement for
hospitals? participation.
Likely, the inclusion of patients taken to elective surgery
without vaginal bleeding (not emergent condition) will be
the best option for the RCT.
How to manage the Complex surgical procedures may be subject to Minor modifications in a certain technique should not be
variability of surgical multiple variations in each of their steps, even by evaluated individually because these small changes are
technique applied in different surgeons within the same hospital. unlikely to produce detectable benefits on their own.
each hospital? However, when considered collectively, they may do so.
RCTs are appropriate when a clear, clinically relevant
choice exists between the techniques.
How to follow the Some patients had a remote residence, and follow- Apply different follow-up strategies (video call, phone,
patients? up on day 42 was not possible in person. email, outpatient appointments).
How to finance the We did not have financial support for this study. Change to a culture of cooperation rather than competition
study? with which each participating hospital contributes
resources for the execution of the study.
LMIC, low- and middle-income countries; OSCS, one step conservative surgery; PAS, placenta accreta spectrum; RCT, randomized controlled trial.
Nieto-Calvache. One-step conservative surgery vs hysterectomy for placenta accreta spectrum. Am J Obstet Gynecol MFM 2024.

whom OSCS is not a good strategy CRediT authorship Software, Writing − review & editing.
(because they do not have enough contribution statement Juan Sebastian Galindo: Formal analy-
healthy myometrium to repair the

Albaro Jos
e Nieto-Calvache: Concep- sis, Software, Supervision, Validation.
uterus) and for whom the first recom- tualization, Data curation, Formal anal- Valentina Galindo-Velasco: Data cura-
mended option would be hysterectomy. ysis, Investigation, Methodology, tion, Writing − review & editing. Luisa
However, there is also a high percentage Project administration, Writing − origi- Fernanda Rivera-Torres: Data cura-
of women with less extensive lesions for nal draft, Writing − review & editing. tion, Writing − review & editing. Juan
whom both OSCS and hysterectomy Rozi Aditya Aryananda: Conceptuali- Manuel Burgos-Luna: Data curation,
would be viable (Table 5). For these zation, Data curation, Formal analysis, Investigation, Writing − review & edit-
patients, the choice between OSCS and Investigation, Methodology, Project ing. Amarnath Bhide: Conceptualiza-
hysterectomy should take into account administration, Writing − original tion, Data curation, Writing − review &
both the patient’s expectations and the draft, Writing − review & editing. Jos
e editing.
expertise of the treating group. The Miguel Palacios-Jaraquemada: Data
choice of surgical technique may need curation, Investigation, Writing −
to be guided by the topographic surgical review & editing. Nareswari Cininta: ACKNOWLEDGMENTS
staging. Data curation, Investigation, Writing −
We thank the Centro de Investigaciones
review & editing. Ariani Grace: Data Clínicas, Fundacio
n Valle del Lili, Cali, Colombia,
curation, Writing − review & editing. for their support in the execution of this study.
Juan Pablo Benavides-Calvache: Data We also extend our gratitude to Philip Sedgwick,
Conclusion curation, Investigation, Writing − origi- BSc, PhD, CStat, SFHEA, Professor of Medical
Statistics and Medical Education, Institute of
An RCT comparing 2 surgical techni- nal draft, Writing − review & editing.
Medical, Biomedical and Allied Health Educa-
ques for the treatment of PAS is feasible. Clara Ivette Campos: Conceptualiza- tion, St. George’s, University of London, for his
OSCS is a valid alternative to hysterec- tion, Investigation, Writing − review & guidance during the study design.
tomy in the large majority of cases, but editing. Adriana Messa-Bryon: Data
this can only be ascertained following curation, Investigation, Writing −
intraoperative surgical staging. The clin- review & editing. Liliana Vallecilla: Supplementary materials
ical outcomes are largely comparable Formal analysis, Investigation, Method- Supplementary material associated with
with these 2 surgical techniques. & ology. Daniela Sarria: Data curation, this article can be found in the online

14 AJOG MFM June 2024

 Original Research

version at doi:10.1016/j.ajogmf.2024. 12. Palacios-Jaraquemada JM, Basanta N, “Triple P Procedure” conservative surgical
101333. Labrousse C, Martínez M. Pregnancy outcome approach. Int J Gynaecol Obstet 2020;148:
in women with prior placenta accreta spectrum 65–71.
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Corresponding author: Albaro Jos
e Nieto-Calvache,
Gynecol MFM 2023;5:100802. mally invasive placenta managed using the MD. [email protected]

June 2024 AJOG MFM 15

Original Research

Cirugía conservadora de un solo paso vs histerectomía para el espectro de acretismo

placentario: un estudio controlado aleatorizado de factibilidad.

ANTECEDENTES
El espectro de la placenta accreta es una condición grave asociada con morbilidad materna significativa e incluso mortalidad. El
tratamiento recomendado es la histerectomía. Una alternativa es la cirugía conservadora de 1- paso, que implica la resección en
bloque del miometrio afectado por el espectro de la placenta accreta junto con la placenta, seguido de la reconstrucción uterina.
Actualmente, no existen estudios que comparen estas dos técnicas en el contexto de un estudio controlado aleatorizado.

OBJETIVO
Realizamos un estudio controlado aleatorizado multicéntrico registrado prospectivamente comparando la histerectomía con la
cirugía conservadora de 1- paso. El objetivo fue recopilar la factibilidad y los resultados clínicos de ambas técnicas en mujeres
asignadas a histerectomía o a cirugía conservadora de 1- paso. Además de evaluar la disposición de las participantes a ser alea-
torizadas, también recopilamos datos sobre la pérdida de sangre intraoperatoria, la necesidad de transfusión, los eventos adver-
sos graves y otros resultados clínicos.

DISEÑO DEL ESTUDIO

Sesenta mujeres con una fuerte sospecha prenatal de espectro de placenta accreta fueron asignadas aleatoriamente a histerecto-
mía (n=31) o cirugía conservadora de 1- paso (n=29).

RESULTADOS
Durante un período de 20 meses, 60 de las 64 pacientes elegibles (93.7%) fueron sometidas a aleatorización. El análisis por
intención de tratar mostró que los resultados clínicos de la cirugía conservadora de 1- paso fueron comparables a los de la his-
terectomía (pérdida de sangre intraoperatoria mediana, 1740 mL [rango intercuartil, 1010−2410] vs 1500 mL [rango intercuar-
til, 1122−2753]; razón de probabilidades, 1 [1−1]; P=.942; duración mediana de la cirugía, 135 minutos [rango intercuartil, 111
−180] vs 155 minutos [rango intercuartil, 120−185]; razón de probabilidades, 0.99 [0.98−1]; P=.151; tasa de transfusión, 58.6%
vs 61.3%; razón de probabilidades, 0.96 [0.83−1.76]; P=.768; y tasa de eventos adversos, 17.2% vs 9.7%; razón de probabili-
dades, 1.77 [0.43−10.19]; P=.398; respectivamente). En el subgrupo de mujeres con clase tipo 1 en la clasificación topográfica,
todas las participantes asignadas a la cirugía de 1- paso tuvieron resultados exitosos, que fueron superiores a los de la histerec-
tomía. Esto se evidenció por menor duración de la cirugía (mediana, 125 [rango intercuartil, 98−128] vs 180 [129−226] minu-
tos; P=.002), menor tasa de transfusión (46.2% vs 82.4%) y menos unidades de glóbulos rojos transfundidas (mediana, 1
[rango intercuartil, 1−1.8] vs 3 [rango intercuartil, 2−4] unidades; P=.007).

CONCLUSIÓN
Un estudio controlado aleatorizado que compara dos técnicas quirúrgicas para el tratamiento del espectro de la placenta
accreta es factible. La reparación conservadora de 1- paso es una alternativa válida a la histerectomía en la gran mayoría de los
casos, pero esto solo puede confirmarse después de la estadificación quirúrgica intraoperatoria.

Palabras clave
accreta, estudio controlado aleatorizado, técnica quirúrgica, cirugía conservadora del útero &

16 AJOG MFM June 2024