Back to resultsAmr's Maneuver and Postpartum Hemorrhage
Primary Purpose
Postpartum Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Amr maneuver
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring postpartum hemorrhage, PPH, atonic, new maneuver
Eligibility 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
Sites / Locations
- Cairo University Hospitals (Kasr Al-Aini)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Amr Maneuver
Active management alone
Arm Description
Active management of third stage plus Amr's maneuver
Active management of third stage alone
Outcomes
Primary Outcome Measures
the incidence of postpartum hemorrhage
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02660567
First Posted
January 19, 2016
Last Updated
May 9, 2019
Sponsor
ClinAmygate
Collaborators
Cairo University, Ain Shams University, October 6 University, National Research Centre, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT02660567
Brief Title
Amr's Maneuver and Postpartum Hemorrhage
Official Title
The Impacts of Using Amr's Maneuver (Cervical Traction) on Atonic Postpartum Hemorrhage; Multi-centre Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
July 20, 2017 (Actual)
Study Completion Date
July 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ClinAmygate
Collaborators
Cairo University, Ain Shams University, October 6 University, National Research Centre, Egypt
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
postpartum hemorrhage, PPH, atonic, new maneuver
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
900 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Amr Maneuver
Arm Type
Experimental
Arm Description
Active management of third stage plus Amr's maneuver
Arm Title
Active management alone
Arm Type
No Intervention
Arm Description
Active management of third stage alone
Intervention Type
Procedure
Intervention Name(s)
Amr maneuver
Intervention Description
sustained traction of the anterior and posterior lips of the cervix by ovum forceps downwards and anteriorly until maximum yield for about 90 seconds
Primary Outcome Measure Information:
Title
the incidence of postpartum hemorrhage
Description
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
Time Frame
24 hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osama Azmy, MD
Organizational Affiliation
Egypt National Research Centre Reproductive Health Research Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emad RH Issak, DM
Organizational Affiliation
ClinAmygate
Official's Role
Study Director
Facility Information:
Facility Name
Cairo University Hospitals (Kasr Al-Aini)
City
Giza
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32609374
Citation
Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663.
Results Reference
derived
PubMed Identifier
30281778
Citation
Hamdy A, Azmy O, Lotfy R, Attia AA, Elsherbini MM, Al Sawaf A, Soliman MM, Sharaf MF, Kamel A, Abd El-Raouf MN, Salem S, Rasheed MA, Torky H, Issak ER. Multicenter randomized controlled trial assessing the impact of a cervical traction maneuver (Amr's maneuver) on the incidence of postpartum hemorrhage. Int J Gynaecol Obstet. 2019 Jan;144(1):56-61. doi: 10.1002/ijgo.12687. Epub 2018 Oct 22.
Results Reference
derived
Learn more about this trial
Amr's Maneuver and Postpartum Hemorrhage
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