Amr's Maneuver and Postpartum Hemorrhage

May 9, 2019 updated by: ClinAmygate

The Impacts of Using Amr's Maneuver (Cervical Traction) on Atonic Postpartum Hemorrhage; Multi-centre Randomized Controlled Study

The impacts of using Amr's manoeuvre (cervical traction) on atonic postpartum hemorrhage is a randomized controlled, multi-centre study that aims to compare the incidence of post partum hemorrhage (PPH> 500 ml blood loss) within the first 24 hours of labor after using Amr's maneuver with active management of the third stage versus active management alone

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary:

Compare the incidence of post partum hemorrhage (PPH> 500 ml blood loss) within the first 24 hours of labor after using Amr's maneuver with active management of the third stage versus active management alone

Secondary:

Comparing:

  • The amount of blood loss in each arm of the study
  • Hematocrit before and after labor
  • Duration from delivery of placenta till discharge from the delivery room

Study Type

Interventional

Enrollment (Actual)

900

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
      • Giza, Egypt
        • Cairo University Hospitals (Kasr Al-Aini)

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All pregnant females aged 18 years or more, candidate for normal vaginal delivery during the period of the study will be included

Exclusion Criteria:

  • Women presenting with pre-existing maternal hemorrhagic conditions such as factor 8 or 9 deficiency or Von Willebrand's disease or those who had assisted vaginal delivery

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amr Maneuver
Active management of third stage plus Amr's maneuver
Procedure: Amr maneuver
sustained traction of the anterior and posterior lips of the cervix by ovum forceps downwards and anteriorly until maximum yield for about 90 seconds
No Intervention: Active management alone
Active management of third stage alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of postpartum hemorrhage
Time Frame: 24 hour
the incidence of post partum hemorrhage (PPH> 500 ml blood loss) within the first 24 hours of labor after using Amr's maneuver with active management of the third stage
24 hour

Collaborators and Investigators

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

Sponsor

ClinAmygate

Collaborators

Cairo University
Ain Shams University
National Research Centre, Egypt
October 6 University

Investigators

  • Principal Investigator: Osama Azmy, MD, Egypt National Research Centre Reproductive Health Research Department
  • Study Director: Emad RH Issak, DM, ClinAmygate

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)

March 1, 2016

Primary Completion (Actual)

July 20, 2017

Study Completion (Actual)

July 20, 2017

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

January 20, 2016

First Posted (Estimate)

January 21, 2016

Study Record Updates

Last Update Posted (Actual)

May 10, 2019

Last Update Submitted That Met QC Criteria

May 9, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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