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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 April 2016
Main ID:  NCT02480556
Date of registration: 22/06/2015
Prospective Registration: Yes
Primary sponsor: Kasr El Aini Hospital
Public title: Comparing Blood Loss During Caesarean Section Between Manual Separation of Placenta & Conservative Management
Scientific title: Comparing Blood Loss Between Manual Separation & Conservative Management for Removal of the Placenta During Caesarean Section; a Randomized Controlled Study
Date of first enrolment: July 2015
Target sample size: 838
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02480556
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention  
Phase:  N/A
Countries of recruitment
Egypt
Contacts
Name:     Ahmed M Kamel, M.D
Address: 
Telephone:
Email:
Affiliation:  Lecturer of obstetrics & gynecology
Key inclusion & exclusion criteria

Inclusion Criteria:

- Inclusion criteria for this study were healthy volunteers scheduled for Caesarean
section, age range between 20-38 years

Exclusion Criteria:

- Exclusion from the study included patients with anemia, abnormal coagulation defects,
multi-fetal gestation, failed progress in ongoing labour, pregnancy induced
hypertension & other factors increasing risk for primary postpartum hemorrhage.
Diagnosed uterine fibroid or mullerian anomalies. A maximum of 10 minutes was allowed
in group B before actively removing the placenta, as a diagnosis of retained placenta
and abnormal placental adhesions is probably the cause and the patient was excluded
from the results



Age minimum: 20 Years
Age maximum: 38 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Haemorrhage
Intervention(s)
Procedure: Conservative separation of placenta
Procedure: manual seperation of the placenta
Primary Outcome(s)
Blood Loss [Time Frame: 10 minutes]
Secondary Outcome(s)
Secondary ID(s)
A22062015
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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