Bilateral Uterine Artery Ligation in Reducing Incidence of Postpartum Hemorrhage in Cesarean Section

March 8, 2019 updated by: Ahmed Mohamed Abbas, Assiut University

Role of Bilateral Uterine Artery Ligation in Reducing Incidence of Postpartum Hemorrhage in Cesarean Section in Patients At Risk of Uterine Atony A Randomized Controlled Trial

The patients were recruited from women attending labor ward to undergo cesarean section.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1070

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo
      • Assiut, Cairo, Egypt, 002
        • Ahmed Abbas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with one or more of the following conditions undergoing cesarean section for obstetric indication were included:
  • Maternal anemia (not less than 7 gm %).
  • Macrosomic baby >4kgs.
  • Twin pregnancy and high order pregnancy.
  • Polyhydramnios.
  • Grand multipara.
  • Previous history of atonic postpartum hemorrhage.
  • Prolonged vaginal delivery.
  • Emergency cesarean.
  • Chorioamnionitis.

Exclusion Criteria:

  • - Placenta previa.
  • Patients with bleeding tendency (congenital or acquired)
  • Ante-partum hemorrhage.
  • Patients with no risk for uterine atony.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
patients at risk of uterine atony undergoing cesarean section underwent bilateral uterine artery ligation and received oxytocin.
Drug: Oxytocin
20 units by slow intravenous drip injection
Procedure: 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.
Active Comparator: control group
patients at risk of uterine atony undergoing cesarean section received oxytocin only.
Drug: Oxytocin
20 units by slow intravenous drip injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean Blood loss after placental separation
Time Frame: 30 minutes
by using weight of soaked towels (weight of soaked towel - weight of dry towel) and amount of blood in suction set
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

July 8, 2018

First Submitted That Met QC Criteria

July 8, 2018

First Posted (Actual)

July 19, 2018

Study Record Updates

Last Update Posted (Actual)

March 11, 2019

Last Update Submitted That Met QC Criteria

March 8, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUALCS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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