Uterine Artery Ligation to Decrease Blood Loss With Central Placenta Previa

March 14, 2016 updated by: Ahmad Sameer Sanad, Minia Maternity University Hospital

Uterine Artery Ligation to Minimize Blood Loss in Patients With Central Placenta Previa

This trial will address the effect of uterine artery ligation during Cesarean section in cases with placenta previa to decrease blood loss.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This Study will address the effect of uterine artery ligation prior to fetal delivery during Cesarean section in cases with central placenta previa to guard against postpartum hemorrhage and to minimize blood loss.

Study Type

Interventional

Enrollment (Actual)

52

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
      • Minia, Egypt, 61111
        • Minia Maternity University Hospital

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

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Placenta previa is diagnosed when the lowest placental edge is located within 5 cm of the internal os at ultrasound
  • Symptomatic Placenta previa with at least one episode of bleeding
  • Estimated gestational age within 28 to 40 weeks
  • Maternal age > 18 years
  • Informed consent
  • Social affiliation

Exclusion Criteria:

  • Premature rupture of membranes
  • Severe bleeding.
  • Abnormal fetal heart rates.
  • Pre-eclampsia, chorioamnionitis, severe chronic renal disease.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ligation group
Uterine artery ligation will be done for patients in this group
Procedure: Uterine artery ligation
Uterine artery ligation during cesarean section before delivery of the baby
Placebo Comparator: Control group
Conventional CS
Procedure: Uterine artery ligation
Uterine artery ligation during cesarean section before delivery of the baby

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in hemoglobin level
Time Frame: hemoglobin level will be done baseline and will be repeated 24 hours after delivery
Changes in hemoglobin level before and after CS will reflect the amount of blood loss during operation
hemoglobin level will be done baseline and will be repeated 24 hours after delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Degree of uterine contractility.
Time Frame: During CS and within 3 hours after CS
During CS and within 3 hours after CS

Collaborators and Investigators

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

Sponsor

Minia Maternity University Hospital

Investigators

  • Principal Investigator: Ahmad S Sameer, MD, Minia Maternity University Hospital

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

November 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

November 29, 2013

First Posted (Estimate)

December 5, 2013

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1150-4666

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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