NCT06575023

Brief Summary

To compare the efficacy of lower uterine tamponade and partial lower myometrial resection in the management of intraoperative bleeding in cases with placenta accreta spectrum .

Trial Health

65
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Trial Health Score

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

Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Sep 2024

Typical duration for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress56%
Sep 2024Aug 2027

First Submitted

Initial submission to the registry

August 19, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2027

Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

August 19, 2024

Last Update Submit

August 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • amount of intraopertive blood loss.

    compare of amount of blood loss between two methods by adding collected blood in suction apparatus in milliliters to amount of biood in the soaked towels

    2 years

Secondary Outcomes (4)

  • ICU admission

    2 years

  • Re exploration

    2 years

  • drop of HB level postoperative

    2 years

  • blood transfusion

    2 years

Study Arms (2)

tamponade of lower uterine segmentin managment of placenta accreta spectrum cases

ACTIVE COMPARATOR

usage of tamponade of the lower uterine segment in managment of placnta accreta spectrum cases

Procedure: Tamponade of lower uterine segment in management of placenta accreta spectrum cases

partial myometrial resection of lower uterine segment in management of placenta accreta spectrum

ACTIVE COMPARATOR

partial resection of lower uterine segment myometrium

Procedure: partial myometrial resection of lower uterine segment in management of placenta accreta spectrum cases

Interventions

To compare the efficacy of lower uterine tamponade and partial lower myometrial resection in the management of intraoperative bleeding in cases with placenta accreta spectrum

tamponade of lower uterine segmentin managment of placenta accreta spectrum cases

tamponade vs partial myomertial resection of lower uterine segment in managment of placenta accreta spectrum cases

partial myometrial resection of lower uterine segment in management of placenta accreta spectrum

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women with placenta previa /PAS diagnosed before delivery (by ultrasound and Doppler examination) .
  • Gestational age starting from 28 weeks onwards. 3- Women with at least 1 previous hysterotomy (e.g. Caesarean deliveries, myomectomy) 4- Elective or emergent Caesarean deliveries

You may not qualify if:

  • A pre-existing decision of performing intrapartum hysterectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sentilhes L, Goffinet F, Kayem G. Management of placenta accreta. Acta Obstet Gynecol Scand. 2013 Oct;92(10):1125-34. doi: 10.1111/aogs.12222.

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Central Study Contacts

Abdelrahman Nabil, master degree

CONTACT

Esraa Badran, assistant professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

August 19, 2024

First Posted

August 28, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2027

Last Updated

August 28, 2024

Record last verified: 2024-08