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NCT00375986 Clinical Trial

A Comparison of Manual vs. Spontaneous Removal of the Placenta at Cesarean Section

Pregnancy Clinical Trial

Official title:
A Comparison of Manual vs. Spontaneous Removal of the Placenta at Cesarean Section

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00375986
Other study ID # 00014248
Secondary ID
Status Completed
Phase N/A
First received September 11, 2006
Last updated November 12, 2007
Start date September 2006
Est. completion date June 2007

Study information
Verified date November 2007
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if there are differences in operative blood loss with manual vs. spontaneous removal of the placenta during cesarean section.

Description:

Patients undergoing scheduled cesarean deliveries are randomized to manual or spontaneous placental removal.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All term pregnant women 18 years of age and older undergoing scheduled cesarean delivery at Strong Memorial Hospital.

Exclusion Criteria:

- Prematurity (<37 weeks)

- Preoperative chorioamnionitis

- Vaginal delivery of fetus

- Emergency Cesarean Delivery

- Patient's OB not agreeable to participating in this study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Procedure:
• Manual placental removal at Cesarean delivery

• Spontaneous placental removal at Cesarean delivery

Locations
Country Name City State
United States Strong Memorial Hospital Rochester New York

Sponsors (1)
Lead Sponsor Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hematocrit levels (preoperatively and within 48 hours postoperatively)
Secondary Number of units of blood transfused intraoperatively and postoperatively
Secondary Development of uterine infection (endometritis)
Secondary Length of postoperative hospital stay
Secondary Operative time
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