NCT04518150

Brief Summary

This study will be performed to compare the effectiveness of routine Bakri balloon tamponade and Bilateral Uterine Artery Ligation during cesarean section in patients with placenta previa

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 15, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

September 21, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

August 15, 2020

Last Update Submit

September 18, 2020

Conditions

Placenta Previa

Outcome Measures

Primary Outcomes (1)

  • mean Blood loss after placental separation

    by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set

    30 minutes

Secondary Outcomes (2)

  • The number of participant needed for blood transfusion

    24 hours

  • Number of Participants with postpartum hemorrhage

    24 hours

Study Arms (2)

study group

EXPERIMENTAL

patients with placenta previa undergoing cesarean section underwent bilateral uterine artery ligation plus insertion of Bakri balloon

Device: Bakri balloonProcedure: Bilateral Uterine Artery Ligation

control group

ACTIVE COMPARATOR

patients with placenta previa undergoing cesarean section underwent insertion of Bakri balloon

Device: Bakri balloon

Interventions

Bakri balloonDEVICE

the Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally

Also known as: BBT
control groupstudy group
Bilateral Uterine Artery LigationPROCEDURE

The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally.

Also known as: BUAL
study group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures

You may not qualify if:

  • patients with the high possibility of morbid adherent placenta
  • those presented with severe antepartum hemorrhage
  • Patients with cardiac, hepatic, renal, or thromboembolic disease;
  • patient refuses to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

RECRUITING

MeSH Terms

Conditions

Placenta Previa

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Study Officials

  • nahla w Shady, md

    Aswan universirty

    STUDY CHAIR

Central Study Contacts

hany f Sallam, md

CONTACT

+20102435461hany.farouk@aswu.edu.eg

nahla w Shady, md

CONTACT

+201022336052hanygyne@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single blind randomized controlled trial
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A Professor

Study Record Dates

First Submitted

August 15, 2020

First Posted

August 19, 2020

Study Start

September 1, 2020

Primary Completion

August 31, 2022

Study Completion

October 31, 2022

Last Updated

September 21, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)