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\begin{document}

\title{Uterus Preservation Versus Caesarean Hysterectomy in Management of
Placenta Accreta Spectrum: A Multicentre International Study}



\author[1]{Sherif Shazly}%
\author[2]{Ismet Hortu}%
\author[3]{Jin-chung Shih}%
\author[1]{Rauf  Melekoglu}%
\author[4]{Shangrong  Fan}%
\author[5]{Farhatulain ahmed}%
\author[6]{Erbil Karaman}%
\author[7]{Ildar Fatkullin}%
\author[8]{Pedro Pinto}%
\author[9]{Setyorini  Irianti}%
\author[10]{Joel  Tochie}%
\author[11]{Amr Abdelbadie}%
\author[12]{Mohamed Ashraf}%
\author[13]{Ahmad Radwan}%
\author[1]{Esraa Sayed}%
\author[1]{Gena Elassall}%
\author[13]{Esraa Hosny}%
\author[13]{Shimaa Ali}%
\author[13]{Ayman Dawood}%
\author[2]{A. Mete Ergenoglu}%
\author[14]{Ahmet Yeniel}%
\author[14]{Sermet  Sagol}%
\author[14]{Ismail Itil}%
\author[3]{Jessica Kang}%
\author[15]{KUAN-YING HUANG}%
\author[16]{Ercan  Yilmaz}%
\author[17]{Yiheng  Liang}%
\author[18]{Hijab Aziz}%
\author[18]{Tayyiba  Akhter}%
\author[18]{Afshan  Ambreen}%
\author[6]{Çağrı  Ateş}%
\author[19]{Yasemin  Karaman}%
\author[7]{Albir Khasanov }%
\author[7]{Larisa Fatkullina }%
\author[7]{Nariman  Akhmadeev}%
\author[7]{Adelina Vatanina }%
\author[8]{Ana Machado}%
\author[8]{Nuno Montenegro}%
\author[9]{Jusuf  Effendi}%
\author[9]{Dodi  Suardi}%
\author[9]{Ahmad Pramatirta}%
\author[9]{Muhamad Aziz}%
\author[9]{Amilia Siddiq}%
\author[20]{Ingrid  Ofakem}%
\author[20]{Julius Dohbit}%
\author[21]{Mohamed Fahmy}%
\author[21]{Mohamed Anan}%
\affil[1]{Affiliation not available}%
\affil[2]{Ege University}%
\affil[3]{National Taiwan University Hospital, National Taiwan University College of Medicine}%
\affil[4]{Peking University Shenzhen Hospital}%
\affil[5]{Department of Obstetrics and Gynaecology, Fatima Memorial Hospital, Punjab, Pakistan}%
\affil[6]{Yuzuncu Yil University Faculty of Medicine}%
\affil[7]{Kazan State Medical University}%
\affil[8]{Centro Hospitalar de São João EPE}%
\affil[9]{Universitas Padjadjaran}%
\affil[10]{Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon}%
\affil[11]{Department of Obstetrics and Gynaecology, Aswan University Hospital, Aswan, Egypt}%
\affil[12]{Assiut University Faculty of Medicine}%
\affil[13]{Assiut University}%
\affil[14]{Ege Universitesi}%
\affil[15]{National Taiwan University Hospital}%
\affil[16]{Inonu University School of Medicine}%
\affil[17]{Peking University}%
\affil[18]{Fatima Memorial Hospital}%
\affil[19]{Van Lokman Hekim Hayat Hospital}%
\affil[20]{University of Yaounde I}%
\affil[21]{Aswan University}%


\vspace{-1em}



  
  \date{May 04, 2024}


\begingroup
\let\center\flushleft
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\selectlanguage{english}
\begin{abstract}
Objective: To compare peripartum outcomes of uterus preserving
procedures to caesarean hysterectomy in women with placenta accreta
spectrum (PAS), and to identify risk factors associated with adverse
maternal outcomes. Design: Retrospective study (ClinicalTrials.gov
identifier: NCT04384510) Setting:11 tertiary centres from 9 countries
Population or Sample: women with of PAS who were managed in
participating centres between January 1st, 2010 and December 31st, 2019.
Women who had confirmed diagnosis with PAS with adequate documentation
and follow-up, were considered eligible. Main Outcome Measures: Primary
outcome was massive PAS-associated perioperative blood loss
(intraoperative blood loss [?] 2500 ml, bleeding associated massive
transfusion protocol, or complicated by disseminated intravascular
coagulopathy). Results: Out of 797 women, 727 were eligible for the
study. Five hundred ninety-two (81.43\%) women were managed by uterus
preserving procedures versus 135 (18.56\%) who underwent caesarean
hysterectomy. After adjustment for significant or close-to-significance
variables, type of management was not associated with higher risk of
massive blood loss (aOR 1.71, 95\% CI 0.78 - 3.81). Other factors that
were significantly associated with higher risk of massive PAS-associated
blood loss included body mass index, preoperative haemoglobin, centrally
located placenta, diffuse placental invasion, parametrial invasion, and
intrauterine foetal death. Conclusions: In the presence of sufficient
experience, uterus preserving procedures may not be associated with
higher risk of massive blood loss compared to caesarean hysterectomy.
Funding: none%
\end{abstract}%



\sloppy


\textbf{Introduction}

Placenta accreta spectrum (PAS) refers to a spectrum of pathological
placental adherence disorders, in which trophoblastic growth invades the
deeper tissue of the uterine wall to various degrees (1). PAS has drawn
considerable attention in the current century since the incidence of PAS
has increased significantly in response to the rising trend of caesarean
deliveries (CD) (2). The incidence of PAS rose from 1 in 4,000
deliveries in the 70s of the last century to 1 in 533 to 1 in 730
deliveries in the last decade (3). PAS is associated with significant
maternal morbidity including massive obstetric haemorrhage,
coagulopathy, ICU admission, mechanical ventilation, infection, and
prolonged hospitalization. Maternal mortality reaches 30\% in some
reports (4).

Caesarean hysterectomy is, by far, the most widely accepted management
of PAS since it promotes controlled surgical circumstances and precludes
massive bleeding from placental disruption. Caesarean hysterectomy is
endorsed by the American College of Obstetricians and Gynecologists
(ACOG) and the Royal College of Obstetricians and Gynaecologists (RCOG)
as a primary approach in women with PAS (5, 6). Nevertheless, the
practice of uterine preservation, which comprise several procedures that
aim at stopping uterine bleeding without removing the uterus, is widely
adopted worldwide (7). This practice is driven by high motivation of
many women to preserve their future fertility, which has led to
increasing experience of performing these procedures (8). However,
evidence on efficacy and safety of most uterus preserving procedures are
limited due to paucity of consistent studies and limited sample size.
These factors have resulted in a wide gap between evidence-based
recommendations and current practice regarding PAS management in many
countries of the world.

Placenta accreta spectrum international database (PAS-ID) is a large
international multi-center study of women with confirmed diagnosis of
PAS. The objective of this study is to compare perioperative massive
blood loss between women who underwent uterus preserving procedures and
caesarean hysterectomy. In addition, the study aims at identifying
antenatal and intrapartum risk factors associated with massive bleeding
in women with PAS.

\textbf{Methods}

Study population

The ``Placenta Accreta Spectrum International Database (PAS-ID)'' is a
multicentre international database of women diagnosed with PAS that was
initiated on January 21\textsuperscript{st}, 2020 by Middle-East
Obstetrics and Gynaecology Graduate Education (MOGGE) Foundation
(\emph{ClinicalTrials.gov identifier: NCT04384510}). A consortium of 11
PAS referral centres, which conduct both caesarean hysterectomy and
uterus preservation, contributed to the study. These centres locate in 9
countries \emph{(Portugal, Russia, Turkey, Taiwan, Indonesia, China,
Pakistan, Egypt, and Cameroon)}, which present 3 different continents.
Data of PAS patients were retrospectively collected between January
1\textsuperscript{st}, 2010 and December 31\textsuperscript{st}, 2019.
Inclusion criteria included clinical and histopathological diagnosis of
PAS, management, and delivery by the respective center, including at
least 6 weeks of postpartum follow-up. Women with deficient
documentation, inadequate antenatal or postpartum follow-up, or no
documented authorization to use clinical data for research purposes,
were excluded from the study. Variability of PAS management protocols
were limited among centres and over time within the same center. In
general, diagnosis of PAS was made by greyscale transabdominal and
transvaginal ultrasound with Doppler assessment during mid-trimester
foetal anatomy scan, which might be repeated if necessary. Magnetic
resonance imaging was confined to cases where extent of invasion beyond
the uterus is suspicious. Women with PAS Patients were counselled on
management options. Deliveries was planned between 35 and 37 weeks of
gestation unless earlier delivery was indicated for emergency situations
or due to another obstetric indication. Either preoperative or
intraoperative ultrasound was performed to localize the placenta.
Intraoperatively, adequate exposure of the lower uterine segment was
made prior to delivery, the uterus was incised away from placental site.
Once the foetus was delivered, uterine bleeding and placental invasion
were assessed to determine surgical approach. Common uterus preserving
procedures included swing of placental bed, vascular ligation, and
compression sutures, most commonly B-Lynch and Nausicaa sutures (9).
Uterine wall resection was considered when area of invasion was
localized, and re-approximation of uterine edges was achievable. Blood
transfusion was determined by clinical assessment until laboratory test
results were available. Interventional radiology was not available in
most centres and was offered to a few patients if it was supported by a
multidisciplinary team decision. Postoperative admission to intensive
care unit (ICU) versus high dependency unit was decided by the surgeon
and the anaesthetist based on maternal hemodynamic stability, laboratory
tests, and the presence of other risk factors.

Data abstraction

Data of eligible patients were reviewed and abstracted using a
standardized spreadsheet that comprise patient baseline
information\emph{(e.g. age, parity, body mass index ``BMI'', ethnicity,
smoking status)}, obstetric and gynaecologic data \emph{(e.g. obstetric
complications, previous CS, prior gynaecologic surgeries)}, medical
history, antepartum and intrapartum disease characteristics \emph{(e.g.
PAS type, complete versus focal uterine wall invasion, bladder invasion,
parametrial invasion, placental location)}, diagnosis \emph{(antepartum
versus intrapartum diagnosis, imaging modality, and gestational age at
diagnosis)}, antepartum haemoglobin level, intraoperative
details\emph{(e.g. hysterectomy versus uterine preservation, uterus
preserving procedures used either surgical or IR-related, success of
uterine preservation, use of preoperative or intraoperative sonographic
assessment, type of uterine incision and its relation to the placenta,
intraoperative blood loss, transfused blood products, surgical
complications)}, maternal outcomes \emph{(success of uterine
preservation, length of hospital stay, admission to intensive care unit
{[}ICU{]}, postoperative complications),} and neonatal outcomes. Data
collection was completed on June 15\textsuperscript{th}, 2020.

Study Outcomes

Primary outcome of the study was massive PAS-associated blood loss. This
indicates intraoperative blood loss equal to or greater than 2500 ml,
blood loss necessitating massive blood transfusion (defined as
transfusion of at least 10 units of packed red blood cells {[}RBCs{]}
within 24 hours) or disseminated intravascular coagulopathy (DIC)
secondary to intraoperative blood loss. Statistical analysis Continuous
variables were described in means and standard deviations/medians and
interquartile ranges (IQR), and categorical variables were summarized in
numbers and percentages. Shapiro-wilk test was used to test normality of
distribution; parametric variables were compared using student's t test
while non-parametric variables were tested using Mann-Whitney U test.
Logistic regression was used to test association between the primary
independent variable (uterus preservation vs. caesarean hysterectomy),
with adjustment for potential confounders, and outcomes (massive
PAS-associated blood loss and admission to ICU). Each independent
variable was first tested using univariable logistic regression and
results were expressed in unadjusted odds ratio (OR) and 95\% confidence
interval (CI). Variables which yielded p-values of less than 0.2 in
univariable logistic regression were included in the final multivariable
logistic regression model. Results were presented as adjusted ORs (aORs)
and 95\% CIs. Statistical analysis was conducted using STATA 16 software
(StataCorp, College Station, TX).

\textbf{Results}

Out of 797 women who were reviewed during data collection, 727 women
were eligible for the study. Five hundred ninety-two (81.43\%) women
were managed by uterus preserving procedures, while 135 (18.56\%)
underwent caesarean hysterectomy. Their mean ages were 32.99 \selectlanguage{ngerman}± 4.94 and
33.83 ± 4.73 years, respectively. Of women manged by uterus preserving
procedures, PAS type was accreta in 293 (49.49\%) and 10 (7.41\%) in
women who had caesarean hysterectomy. Placenta percreta was present 86
(63.70\%) of women who had caesarean hysterectomy. In women managed by
caesarean hysterectomy, placental site was most commonly central,
covering the internal os in 78 (57.78\%) women, while it was equally
localized anterior low, posterior low, or central in women who had
uterus preservation. Among women who were treated with uterus preserving
procedures, compression sutures were applied to 195 (32.94\%) patients,
placental bed swing was done in 115 (19.43\%) patients, vascular
ligation was performed in 89 (15.03\%), and local uterine wall resection
was achieved in 33 (5.57\%) patients. Uterus preservation was
unsuccessful in 20.1\% of cases. Massive blood loss was reported in 129
(17.74\%) of women. Patient characteristics, PAS features and management
approaches are summarized in Table 1.

Incidence of intraoperative complications were significantly higher
among women manged by caesarean hysterectomy. Specifically,
unintentional cystotomy occurred in 33 (24.44\%) women in the
``caesarean hysterectomy'' group compared to 41 (6.93\%) in the ``uterus
preservation'' group (p \textless{} 0.0001). Otherwise, bowel and
ureteric injuries were comparable in both groups. PAS-associated massive
blood loss was more common in ``caesarean hysterectomy'' group compared
to ``uterus preservation'' group (43 {[}31.9\%{]} vs. 86 {[}14.5\%{]},
respectively; \emph{p} \textless{} 0.0001). There was no significant
difference in the incidence of maternal admission to ICU between the 2
groups. Table 2 shows a summary of clinical outcomes of treatment
groups.

On univariate analysis, uterus preservation was associated with lower
risk of PAS-associated massive blood loss (unadjusted OR 0.36, 95\% CI
0.24 - 0.56). After adjustment for significant or close-to-significance
variables, management approach was not associated with higher risk of
massive blood loss (aOR 1.71, 95\% CI 0.78 - 3.81). Massive blood loss
was significantly associated with BMI (aOR 1.09, 95\% CI 1.02 - 1.15),
gestational age at diagnosis (aOR 1.08, 95\% CI 1.02 - 1.14),
preoperative haemoglobin (aOR 0.77, 95\% CI 0.65 - 0.92), interventional
radiology (aOR 5.62, 95\% CI 2.38 - 13.29), centrally located placenta
(aOR 2.28, 95\% CI 1.25 - 4.18), diffuse versus localized invasion (aOR
3.15, 95\% 1.61 - 6.16), incision away from the placenta (aOR 0.26, 95\%
CI 0.13 - 0.51), bladder invasion (aOR 3.08, 95\% CI 1.95 -- 8.61),
parametrial invasion (aOR 5.37, 95\% CI 1.21 -- 23.79), and intrauterine
foetal death (aOR 10.25, 95\% CI 1.51 -- 69.34) (Table 3).

\textbf{Discussion}

\emph{Main Findings}

In the current study, data from a multicentre study was used to compare
uterus preserving procedure to caesarean hysterectomy in women with PAS.
After adjusting for potential confounders, uterus preserving procedures
did not seem to increase risk of perioperative massive blood loss. Our
results also showed that increased BMI, more advanced gestational age at
diagnosis of PAS, use of interventional radiology, centrally located
placenta over the internal os, diffuse placental invasion, parametrial
and bladder invasion, and intrauterine foetal death were risk factors
for massive blood loss. On the other side, higher preoperative
haemoglobin, and uterine incision away from the placenta were both
protective against significant bleeding. Incidence of complications
between the two approaches were comparable with higher incidence in
unintentional cystotomy in women undergoing caesarean hysterectomy.

\emph{Strengths and limitations}

The study is supported by a large PAS cohort, that is representative of
international practice. The study conveyed results of the most used
conservative approaches. The study precluded the confounding effect of
most clinically relevant determinants of outcomes. However, the study
was limited by the inherent disadvantages of retrospective studies.
Retrospective approach was selected due to recruitment difficulties
associated with uncommon disorders. The study did not include all uterus
preserving procedures, such as ``leaving the placenta in situ'', which
may be less commonly adopted. The study did not include antenatal
sonographic features, which were not feasible to assess and include in
retrospect while outcomes were already known.

\emph{Interpretation}

Uterus preserving procedures are considered by many obstetricians
worldwide in women with PAS who are highly motivated to preserve their
fertility. However, evidence on safety of these procedures is lacking
and therefore, their use has not been endorsed by guidelines. An
exception is ``leaving the placenta in situ'', which is considered by
RCOG and FIGO (the International Federation of Gynaecology and
Obstetrics) (6, 10). Unfortunately, this approach is not commonly
incorporated in practice due to concerns on complexity of postpartum
care and possibility of serious complications (11). Uterus preserving
procedures lack evidence-based support because data are derived from
small studies, which usually present new or modified techniques rather
than validation of a previous technique (12, 13). In addition, many of
these studies do not define criteria of eligible women for uterus
preserving procedures versus caesarean hysterectomy. Instead, they
describe a successful technique that was performed on a selected group
of patients. Paucity of cases of PAS is another barrier to validation of
these studies. Therefore, available data are unlikely to draw a robust
conclusion on these procedures. PAS-ID was created to permit studying of
a large cohort of women with PAS, that were managed by centres that
offer both caesarean hysterectomy and uterus preserving procedures. The
study was conducted internationally to convey spectrum of the most
widely accepted management options, which were noticeably consistent.

Although current results seem to support uterus preserving procedures as
a safe alternative to caesarean hysterectomy in women interested in
future fertility, this conclusion should be cautiously interpreted. The
study was conducted in PAS referral centres, with long experience in
uterus preserving procedures. Since these procedures are not recognized
or no longer supported in many countries, experience is limited to some
foreign obstetricians and similar results cannot be granted.
Accordingly, uterus preserving procedures should only be considered in
experienced centres. However, incorporation of uterus preservation
training, as a part of a PAS training program, may be encouraged to
rebuild and enhance this experience particularly in nationally
recognized PAS centres. Interpretation of our results should also
encompass patient selection. There were no strict criteria to define
which women were considered for uterus preserving procedures in our
cohort other than patient preference, and the decision was mainly made
intraoperatively. Therefore, our results may be caused by appropriate
obstetricians' judgement in patient selection, which should be
recapitulated into criteria to facilitate reproducibility of outcomes.
Accordingly, we defined factors which would alter risk of massive blood
loss to improve selection process. While relation of these factors to
blood loss, such as parametrial invasion, are apparently justifiable,
clinical judgement of these factors is necessary. For example,
interventional radiology is probably associated with, rather than
causative of, massive blood loss since selected women may be those at
higher risk of significant intraoperative bleeding. Moreover, a previous
study on women who were managed with uterus preserving procedures was
conducted using the same database, to create a scoring system that
predict success of these procedures. The MOGGE CON-PAS score comprises
specific parameters that can be used to calculate probability of success
of uterine preservation and can be used to improve selection process
(14).

\textbf{Conclusion}

uterus preservation procedures may be comparable to caesarean
hysterectomy in probability of perioperative massive blood loss if
robust experience in performing these procedures is available. Awareness
of antenatal and intraoperative risk factors is crucial for proper
patient selection. However, prospective studies may be recommended to
validate these conclusions.

\textbf{Acknowledgements:} none

\textbf{Disclosure of Interests:} The authors have no conflicts of
interest. No financial disclosure to declare

\textbf{Contribution to Authorship:}

SAS: principal investigator, study concept, study design, data analysis,
manuscript writing

IH: Regional principal investigator, study design and data collection,
manuscript reviewing

J-C S: Regional principal investigator, study design and data
collection, manuscript reviewing

RM: Regional principal investigator, study design and data collection,
manuscript reviewing

SF: Regional principal investigator, study design and data collection,
manuscript reviewing

FAA: Regional principal investigator, study design and data collection,
manuscript reviewing

EK: Regional principal investigator, study design and data collection,
manuscript reviewing

IF: Regional principal investigator, study design and data collection,
manuscript reviewing

PVP: Regional principal investigator, study design and data collection,
manuscript reviewing

SI: Regional principal investigator, study design and data collection,
manuscript reviewing

JNT: Regional principal investigator, study design and data collection,
manuscript reviewing

ASA: Regional principal investigator, study design and data collection,
manuscript reviewing

MAS: Data cleaning, statistical analysis, manuscript writing, manuscript
reviewing

AAR: Data cleaning, statistical analysis, manuscript writing, manuscript
reviewing

EGS: Data cleaning, statistical analysis, manuscript writing, manuscript
reviewing

GME: Data cleaning, statistical analysis, manuscript writing, manuscript
reviewing

EMH: Data cleaning, statistical analysis, manuscript writing, manuscript
reviewing

SSA: Data cleaning, statistical analysis, manuscript writing, manuscript
reviewing

ASD: Study design, manuscript writing, manuscript reviewing

AME: Study coordinator, data collection, manuscript reviewing

AOY: Data collection, review of collected data and quality assessment,
manuscript reviewing

SS: Data collection, review of collected data and quality assessment,
manuscript reviewing

IMI: Study coordinator, data collection, manuscript reviewing

JK: Data collection, review of collected data and quality assessment,
manuscript reviewing

KYH: Data collection, review of collected data and quality assessment,
manuscript reviewing

EY: Study coordinator, data collection, manuscript reviewing

YL: Study coordinator, data collection, manuscript reviewing

HA: Data collection, review of collected data and quality assessment,
manuscript reviewing

TA: Data collection, review of collected data and quality assessment,
manuscript reviewing

AA: Data collection, review of collected data and quality assessment,
manuscript reviewing

ÇA: Study coordinator, data collection, manuscript reviewing

YK: Data collection, review of collected data and quality assessment,
manuscript reviewing

AK: Data collection, review of collected data and quality assessment,
manuscript reviewing

LF: Data collection, review of collected data and quality assessment,
manuscript reviewing

NA: Study coordinator, data collection, manuscript reviewing

AV: Study coordinator, data collection, manuscript reviewing

AM: Data collection, review of collected data and quality assessment,
manuscript reviewing

SG: Data collection, review of collected data and quality assessment,
manuscript reviewing

NM: Data collection, review of collected data and quality assessment,
manuscript reviewing

JSE: Study coordinator, data collection, manuscript reviewing

DS: Data collection, review of collected data and quality assessment,
manuscript reviewing

AYP: Data collection, review of collected data and quality assessment,
manuscript reviewing

MAA: Study coordinator, data collection, manuscript reviewing

AS: Data collection, review of collected data and quality assessment,
manuscript reviewing

IO: Data collection, review of collected data and quality assessment,
manuscript reviewing

JSD: Study coordinator, data collection, manuscript reviewing

MSF: Data collection, review of collected data and quality assessment,
manuscript reviewing

MAA: Data collection, review of collected data and quality assessment,
manuscript reviewing

\textbf{Details of Ethics Approval:}

Before the study was conducted, all participating centers obtained
institutional review board (IRB) approval. Primary IRB approval was
issued in Aswan University by Aswan faculty of medicine ethics committee
(\emph{date: 11/2/2020; reference number: Aswu/439/2/20}). The study was
approved by the Inonu University scientific research and ethical
committee on 3/3/2020 (\emph{reference number: 2020/476}), by Ege
University IRB on 14/4/2020 (\emph{reference number: 20-4.1 T/3}), by
Fatima memorial hospital/college of medicine and dentistry on 5/12/2020
(\emph{reference number:} \emph{FMH-03-2020-IRB747-M}), by Van Yuzuncu
yil University ethical board on 09/06/2020 (\emph{reference number:
55163642-100-E.36909}), by Kazan State University local ethical
committee on 30/6/2020 (\emph{reference number: 1765}), by Centro
Hospitalar São João ethics committee on 21/5/2020 (\emph{reference
number: 76/2020}), National Taiwan University College of Medicine
ethical committee on 30/3/2020 (\emph{reference number: 202003007RINC}),
Faculty of Medicine of University of Yaoundé I ethical committee on
25/2/2020 (\emph{reference numbers: 1019/CIERSH/DM/2020}). Both Peking
University Shenzhen Hospital and Universitas Padjadjaran Bandung were
waived for the minimal risk per their local hospital policies.

\textbf{Funding:} None



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