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Comparing Blood Loss During Caesarean Section Between Manual Separation of Placenta & Conservative Management

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ClinicalTrials.gov Identifier: NCT02480556
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmed M.Kamel, Kasr El Aini Hospital

Brief Summary:
to compare the blood loss during caesarean section between two different methods of separating the placenta after fetal extraction, keeping in mind that most blood loss occurs after placental separation.

Condition or disease Intervention/treatment Phase
Haemorrhage Procedure: manual seperation of the placenta Procedure: Conservative separation of placenta Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 838 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Comparing Blood Loss Between Manual Separation & Conservative Management for Removal of the Placenta During Caesarean Section; a Randomized Controlled Study
Study Start Date : July 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A
manual seperation of the placenta
Procedure: manual seperation of the placenta
manual separation of the placenta will be done immediately after fetal extraction & cord clamping, where the fingers of the surgeon will be insinuated between the margin of the placenta and the uterine cavity, then by sawing movement and controlled traction by the other hand till placenta is separated from the uterine cavity

Active Comparator: Group B
Conservative separation of placenta
Procedure: Conservative separation of placenta

Conservative separation of placenta:

in group B but following fetal extraction and cord clamping, the placenta will be left insitu & uterus is massaged awaiting spontaneous placental separation





Primary Outcome Measures :
  1. Blood Loss [ Time Frame: 10 minutes ]


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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480556


Locations
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Egypt
11562
Garden City, Cairo, Egypt, 11562
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Principal Investigator: Ahmed M Kamel, M.D Lecturer of obstetrics & gynecology

Publications:
AWHONN Practice Brief (2014): Quantification of Blood Loss: AWHONN Practice Brief Number 1. JOGNN, 00, 1-3; 2014. DOI: 10.1111/1552-6909.12519.

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Responsible Party: Ahmed M.Kamel, Lecturer of Obstetrics & gynecology, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT02480556     History of Changes
Other Study ID Numbers: A22062015
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: March 3, 2016
Last Verified: August 2015

Keywords provided by Ahmed M.Kamel, Kasr El Aini Hospital:
blood loss; caesarean section ; manual placental separation

Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes