Bilateral Uterine Artery Ligation During the Cesarean Delivery of Twins

NCT ID: NCT04518176

Last Updated: 2020-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-08-31

Brief Summary

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Objective to assess the effectiveness of prophylactic bilateral uterine artery ligation (BUAL) in reducing the incidence of postpartum hemorrhage during cesarean delivery among women with twin pregnancy

Detailed Description

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A randomized clinical trial at Aswan University Maternity Hospital, Egypt. Women with twin pregnancy undergoing scheduled or emergency cesarean were randomized into two groups. In the BUAL group, women underwent BUAL before placental delivery; in the control group, women had cesarean delivery without BUAL. The primary outcome was the estimated blood loss during a cesarean

Conditions

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Cesarean Section Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized controlled study
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

open label randomized controlled study

Study Groups

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study group

patients with twin pregnancy undergoing cesarean section underwent bilateral uterine artery ligation and received oxytocin.

Group Type EXPERIMENTAL

bilateral uterine artery ligation

Intervention Type PROCEDURE

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

Oxytocin

Intervention Type DRUG

20 units by slow intravenous drip injection

control group

patients with twin pregnancy undergoing cesarean section received oxytocin only.

Group Type ACTIVE_COMPARATOR

Oxytocin

Intervention Type DRUG

20 units by slow intravenous drip injection

Interventions

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bilateral uterine artery ligation

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

Intervention Type PROCEDURE

Oxytocin

20 units by slow intravenous drip injection

Intervention Type DRUG

Other Intervention Names

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BUAL

Eligibility Criteria

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Inclusion Criteria

* women undergoing cesarean section
* twin pregnancy

Exclusion Criteria

* Placenta previa.
* Ante-partum hemorrhage.
* patient refuse to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aswan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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hany farouk

A Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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nahla w Shady, md

Role: STUDY_CHAIR

Aswan universirty

Locations

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Aswan University Hospital

Aswān, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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hany f Sallam, md

Role: CONTACT

+20102435461 ext. 002

nahla w Shady, md

Role: CONTACT

+201022336052 ext. 002

Facility Contacts

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Hany F Sallam, MD

Role: primary

0122336052 ext. 002

Nahla W Shady, MD

Role: backup

01092440504 ext. 002

Other Identifiers

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aswu/279/8/18

Identifier Type: -

Identifier Source: org_study_id

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