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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02660567
Other study ID # 15127
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date July 20, 2017

Study information

Verified date May 2019
Source ClinAmygate
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 900
Est. completion date July 20, 2017
Est. primary completion date July 20, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Cairo University Hospitals (Kasr Al-Aini) Giza

Sponsors (5)

Lead Sponsor Collaborator
ClinAmygate Ain Shams University, Cairo University, National Research Center, Egypt, October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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