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Obstetric ComplicationNCT06861972

Caesarean Hysterectomy Versus Conservative Management of Placenta Accreta: A Comparative Study

An observational study of Obstetric Complication, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Placenta accreta rates are rising alongside the rising rates of caesarean deliveries. This has lead to a vast number of studies negotiating the histopathological nature, risk factors and outcomes of pregnancies complicated with placenta accreta. Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Obstetric Complication
What is being tested?
Caesarean Hysterectomy and Conservative management
Type of treatment
Surgery or procedure
How many people
36 participants
Where
1 siteEgypt
Study dates
1 Apr 2025to 30 Sep 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: A total number of 36 pregnant patients at or after 34 weeks diagnosed of having placenta accreta spectrum were admitted and managed in Kasr Al-Ainy School of Medicine Hospital.

Who may be able to join

  • Singleton pregnancy with living fetus
  • Average liquor: 5-25 cm
  • Gestational age ≥ 34 weeks at time of termination
  • Previous lower segment cesarean section/s
  • Suspected placenta accreta spectrum.

Who cannot join

  • Hepatic, cardio-pulmonary or coagulation disorders
  • Hemoglobin< 9.5g/dl
  • Ruptured membranes
  • Need for emergency delivery as Antepartum hemorrhage or contractions
  • Placental abruption
  • Lower uterine segment fibroids
  • Consent withdrawal

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Cairo University Hospitals

    Cairo, 11261

Other trials in Egypt

About this study

Placenta accreta rates are rising alongside the rising rates of caesarean deliveries. This has lead to a vast number of studies negotiating the histopathological nature, risk factors and outcomes of pregnancies complicated with placenta accreta. In the study the investigators re discussing the outcome of different plans of management of placenta accreta, namely caesarean hysterectomy and focal myometrium resection.

Read the detailed description

Rising rates of caesarean delivery worldwide and especially in Egypt have affected higher rates of placenta accreta spectrum disorders. The increasing prevalence of this life-threatening condition can be primarily prevented by efforts targeted at reducing primary caesarean deliveries as well as encouraging trial of labor after caesarean deliveries of carefully selected gravidas in well-equipped hospitals, capable of providing continuous electronic fetal heart rate monitoring, along with offering one to one health care based systems with the capability of performing emergency caesarean deliveries when needed. As for secondary prevention, the best surgical approach to uterine incisions in caesarean deliveries is yet to be found and universally applied. The said approach will aim at decreasing short and long term complications of uterine scarification resulting in decreased number of placenta accreta cases and possibly downgrading their difficulty, too. Having failed to prevent such occurrence, optimization of PAS management can be attempted to try and decrease implicated injuries. As previously noted, multidisciplinary systematic approach of managing placenta accreta spectrum disorders is indispensable to reduce maternal morbidity and mortality afflicted by this grave condition. The said approach begins with identification of the risk factors of PAS occurrence, calculating pretest probability of PAS and thus early suspicion and referral can be offered by the widely applicable 2nd trimester anomaly scan. After confirming the diagnosis in the 3rd trimester, birthing plans are formulated according to the gravity of the condition assessed by the patient's clinical condition, the ultrasound scan signs, together with social factors as proximity to a healthcare facility capable of offering such management alongside the maternal take on prolonged hospitalization. Decision making and choosing the place of delivery is shared between the pregnant lady, her birth companion and her following up obstetrician. Since elective management of such cases has been proven to be associated with less adjacent organ injuries and associated morbidities, late preterm delivery is usually elected after a course of antenatal corticosteroids as per local protocol.

Guidelines concerned with PAS management still consider caesarean hysterectomy as the main management of placenta accreta disorders. Owing to the high rate of associated morbidity with caesarean hysterectomy, different researchers are hunting down updated recent management approaches with less morbidity and mortality.

Our study evaluated different outcomes with conservative management of placenta accreta spectrum disorders, namely, focal myometrium resection of the adherent defective myometrium along with its overlying placenta after devascularization, as opposed to caesarean hysterectomy. Data will be observed in a total of 36 PAS patients managed in the OBGYN department, in Kasr Al-Ainy School of medicine hospital, with 18 patients undergoing the previously explained conservative management and 18 patients undergoing caesarean hysterectomy. Demographic data of both study groups, alongside operative time, adjacent organ injury estimated blood loss, need for blood transfusion, Inotropic support and ICU admission will be collected, recorded and analyzed.

Being tested
Caesarean Hysterectomy, Conservative management

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Caesarean HysterectomyProcedure or surgery

    Caesarean delivery followed by hysterectomy

  • Conservative managementProcedure or surgery

    Focal myometrium resection of the area of diseased myometrium after delivery

Study groups in NCT06861972
Study groupRoleWhat they receive
1 (Caesarean Hysterectomy group)patients with placenta accreta spectrum undergoing caesarean hysterectomy.
Receives: Procedure: Caesarean Hysterectomy
2 ( Conservative Management group)patients with placenta accreta spectrum undergoing focal myometrium resection
Receives: Procedure: Conservative management

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. operative blood loss

    hemoglobin deficit in mg/dl

    Measured: 6 months

Secondary outcomes (5)
  1. operative blood loss

    visual estimation of operative blood loss in ml

    Measured: 6months

  2. need for blood products transfusion

    no of blood products transfused in both groups in no. of units

    Measured: 6months

  3. adjacent organ injuries

    rates of urinary bladder or ureteric injuries

    Measured: 6months

  4. operative time

    operative time in minutes

    Measured: 6months

  5. ICU admission

    need for ICU admission and length of stay in days

    Measured: 6months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2025
  2. Study start1 Apr 2025
  3. Primary completion1 Sep 2025
  4. Study completion30 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06861972
Sponsor's protocol ID
MD-13-2023
Status last verified
Mar 2025
First submitted
14 Jan 2025
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Collins SL, Chantraine F, Morgan TK, Jauniaux E. Abnormally adherent and invasive placenta: a spectrum disorder in need of a name. Ultrasound Obstet Gynecol. 2018 Feb;51(2):165-166. doi: 10.1002/uog.18982. No abstract available.

    PubMed 29231264
  • Nieto-Calvache AJ, Palacios-Jaraquemada JM, Osanan G, Cortes-Charry R, Aryananda RA, Bangal VB, Slaoui A, Abbas AM, Akaba GO, Joshua ZN, Vergara Galliadi LM, Nieto-Calvache AS, Sanin-Blair JE, Burgos-Luna JM; Latin American group for the study of placenta accreta spectrum. Lack of experience is a main cause of maternal death in placenta accreta spectrum patients. Acta Obstet Gynecol Scand. 2021 Aug;100(8):1445-1453. doi: 10.1111/aogs.14163. Epub 2021 May 24.

    PubMed 33896009
  • Jauniaux E, Jurkovic D. Placenta accreta: pathogenesis of a 20th century iatrogenic uterine disease. Placenta. 2012 Apr;33(4):244-51. doi: 10.1016/j.placenta.2011.11.010. Epub 2012 Jan 28.

    PubMed 22284667

Questions about this trial

What is this clinical trial studying?

An observational study of Obstetric Complication, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

operative blood loss (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06861972, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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