Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta

July 7, 2020 updated by: Mohamed S Sweed, MD, Ain Shams University

Internal Iliac Artery Ligation Before Cesarean Hysterectomy in Morbidly Adherent Placenta: A Randomized Clinical Trial

40 pregnant females at term diagnosed with morbidly adherent placenta and planned for elective cesarean section were recruited and randomized to 2 groups. Group A: Internal iliac ligation followed by cesarean hysterectomy. Group B: cesarean hysterectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

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, Egypt
        • Ain shams university maternity 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

25 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Placenta previa accreta
  • Previous 2 cesarean section
  • completed her family
  • Hemoglobin > 11 gm/dl
  • Elective cesarean hysterectomy

Exclusion Criteria:

  • Anemia ( Hemoglobin < 11 gm/dl)
  • Not completed her family
  • BMI > 35 Kg/m2
  • Bleeding tendency
  • Emergengy cesarean section
  • Thrombophilia

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: internal iliac artery ligation + cesarean hysterectomy
Procedure: Internal iliac artery ligation
Internal iliac artery ligation and cesarean hysterectomy
Other Names:
  • cesarean hysterectomy
Procedure: cesarean hysterectomy
cesarean hysterectomy
Active Comparator: cesarean hysterectomy
Procedure: cesarean hysterectomy
cesarean hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of blood loss
Time Frame: intraoperative
intraoperative
Amount of Blood transfusion needed in mililiters
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: intraoperative
intraoperative
change of hemoglobin
Time Frame: 24 hours
24 hours
change of hematocrit
Time Frame: 24 hours
24 hours
incidence of injury of important structures during operation
Time Frame: intraoperative
incidence of injury of important structures during operation as urinary bladder, ureteric, intestinal or great vessels injury
intraoperative

Collaborators and Investigators

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

Sponsor

Ain Shams University

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)

March 1, 2017

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

July 2, 2020

Study Registration Dates

First Submitted

January 26, 2019

First Submitted That Met QC Criteria

January 30, 2019

First Posted (Actual)

January 31, 2019

Study Record Updates

Last Update Posted (Actual)

July 8, 2020

Last Update Submitted That Met QC Criteria

July 7, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AS1862

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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