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

Not Applicable

Completed

• Conditions: Pregnancy; Cesarean Section

• Registration Number: NCT00375986
• Lead Sponsor: University of Rochester

Brief 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.

Detailed Description

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

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-11
• Study First Submitted QC: 2006-09-12
• Study First Posted: 2006-09-13
• Study Completion: 2007-06
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-12
• Last Update Posted: 2007-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Hematocrit levels (preoperatively and within 48 hours postoperatively)

Secondary Outcome Measures

Name	Time	Method
Number of units of blood transfused intraoperatively and postoperatively
Development of uterine infection (endometritis)
Length of postoperative hospital stay
Operative time

Trial Locations

Locations (1)

Strong Memorial Hospital; 🇺🇸 Rochester, New York, United States