NCT02660567

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2017

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

1.4 years

First QC Date

January 19, 2016

Last Update Submit

May 9, 2019

Conditions

Postpartum Hemorrhage

Keywords

postpartum hemorrhagePPHatonicnew maneuver

Outcome Measures

Primary Outcomes (1)

  • 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

    24 hour

Study Arms (2)

Amr Maneuver

EXPERIMENTAL

Active management of third stage plus Amr's maneuver

Procedure: Amr maneuver

Active management alone

NO INTERVENTION

Active management of third stage alone

Interventions

Amr maneuverPROCEDURE

sustained traction of the anterior and posterior lips of the cervix by ovum forceps downwards and anteriorly until maximum yield for about 90 seconds

Amr Maneuver

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University Hospitals (Kasr Al-Aini)

Giza, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 32609374DERIVED

  • 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.

    PMID: 30281778DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Osama Azmy, MD

    Egypt National Research Centre Reproductive Health Research Department

    PRINCIPAL INVESTIGATOR

  • Emad RH Issak, DM

    ClinAmygate

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2016

First Posted

January 21, 2016

Study Start

March 1, 2016

Primary Completion

July 20, 2017

Study Completion

July 20, 2017

Last Updated

May 10, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)