Amr's Maneuver and Postpartum Hemorrhage

NCT ID: NCT02660567

Last Updated: 2019-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-07-20

Brief Summary

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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

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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

Conditions

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Postpartum Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Amr Maneuver

Active management of third stage plus Amr's maneuver

Group Type EXPERIMENTAL

Amr maneuver

Intervention Type PROCEDURE

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

Active management alone

Active management of third stage alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Ain Shams University

OTHER

Sponsor Role collaborator

October 6 University

OTHER

Sponsor Role collaborator

National Research Centre, Egypt

OTHER

Sponsor Role collaborator

ClinAmygate

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Osama Azmy, MD

Role: PRINCIPAL_INVESTIGATOR

Egypt National Research Centre Reproductive Health Research Department

Emad RH Issak, DM

Role: STUDY_DIRECTOR

ClinAmygate

Locations

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Cairo University Hospitals (Kasr Al-Aini)

Giza, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 32609374 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30281778 (View on PubMed)

Other Identifiers

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15127

Identifier Type: -

Identifier Source: org_study_id

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