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Amr's Maneuver and Postpartum Hemorrhage

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ClinicalTrials.gov Identifier: NCT02660567
Recruitment Status : Completed
First Posted : January 21, 2016
Last Update Posted : May 10, 2019
Sponsor:
Collaborators:
Cairo University
Ain Shams University
October 6 University
National Research Center, Egypt
Information provided by (Responsible Party):
ClinAmygate

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Procedure: Amr maneuver Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Impacts of Using Amr's Maneuver (Cervical Traction) on Atonic Postpartum Hemorrhage; Multi-centre Randomized Controlled Study
Actual Study Start Date : March 2016
Actual Primary Completion Date : July 20, 2017
Actual Study Completion Date : July 20, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02660567


Locations
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Egypt
Cairo University Hospitals (Kasr Al-Aini)
Giza, Egypt
Sponsors and Collaborators
ClinAmygate
Cairo University
Ain Shams University
October 6 University
National Research Center, Egypt
Investigators
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Principal Investigator: Osama Azmy, MD Egypt National Research Centre Reproductive Health Research Department
Study Director: Emad RH Issak, DM ClinAmygate

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: ClinAmygate
ClinicalTrials.gov Identifier: NCT02660567     History of Changes
Other Study ID Numbers: 15127
First Posted: January 21, 2016    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by ClinAmygate:
postpartum hemorrhage
PPH
atonic
new maneuver

Additional relevant MeSH terms:
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Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage