NCT06861972

Brief 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. In the study the investigators re discussing the outcome of different plans of management of placenta accreta, namely caesarean hysterectomy and focal myometrium resection.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

March 6, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

January 14, 2025

Last Update Submit

March 2, 2025

Conditions

Obstetric Complication

Outcome Measures

Primary Outcomes (1)

  • operative blood loss

    hemoglobin deficit in mg/dl

    6 months

Secondary Outcomes (5)

  • operative blood loss

    6months

  • need for blood products transfusion

    6months

  • adjacent organ injuries

    6months

  • operative time

    6months

  • ICU admission

    6months

Study Arms (2)

1 (Caesarean Hysterectomy group)

patients with placenta accreta spectrum undergoing caesarean hysterectomy.

Procedure: Caesarean Hysterectomy

2 ( Conservative Management group)

patients with placenta accreta spectrum undergoing focal myometrium resection

Procedure: Conservative management

Interventions

Caesarean HysterectomyPROCEDURE

Caesarean delivery followed by hysterectomy

1 (Caesarean Hysterectomy group)
Conservative managementPROCEDURE

Focal myometrium resection of the area of diseased myometrium after delivery

2 ( Conservative Management group)

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 29231264RESULT

  • 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.

    PMID: 33896009RESULT

  • 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.

    PMID: 22284667RESULT

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

uterine corpus in hysterectomy and areas resected out of the myometrium in focal myometrium resection.

MeSH Terms

Interventions

Conservative Treatment

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

ahmed elharty, MD

CONTACT

01063574555Dr.ahmed.alharthy@gmail.com

aya elbeheiry

CONTACT

01276097367aya.elbeheiry91@icloud.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 14, 2025

First Posted

March 6, 2025

Study Start

April 1, 2025

Primary Completion

September 1, 2025

Study Completion

September 30, 2025

Last Updated

March 6, 2025

Record last verified: 2025-03