Amr’s Maneuver and Postpartum Hemorrhage

Overview

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

Full Title of Study: “The Impacts of Using Amr’s Maneuver (Cervical Traction) on Atonic Postpartum Hemorrhage; Multi-centre Randomized Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Participant)
  • Study Primary Completion Date: July 20, 2017

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

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Amr Maneuver
    • Active management of third stage plus Amr’s maneuver
  • No Intervention: Active management alone
    • Active management of third stage alone

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • ClinAmygate
  • Collaborator
    • Cairo University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Osama Azmy, MD, Principal Investigator, Egypt National Research Centre Reproductive Health Research Department
    • Emad RH Issak, DM, Study Director, ClinAmygate

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