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

This study has been completed.
Sponsor:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00375986
First received: September 11, 2006
Last updated: November 12, 2007
Last verified: November 2007
History of Changes
  Purpose

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.


Condition Intervention
Pregnancy
Cesarean Section
 Procedure: Manual placental removal at Cesarean delivery
Procedure: Spontaneous placental removal at Cesarean delivery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Comparison of Manual vs. Spontaneous Removal of the Placenta at Cesarean Section

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Hematocrit levels (preoperatively and within 48 hours postoperatively)

Secondary Outcome Measures:
  • Number of units of blood transfused intraoperatively and postoperatively
  • Development of uterine infection (endometritis)
  • Length of postoperative hospital stay
  • Operative time

Estimated Enrollment: 150
Study Start Date: September 2006
Study Completion Date: June 2007
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00375986

Locations
United States, New York
Strong Memorial Hospital
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Eva K. Pressman, MD University of Rochester
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00375986     History of Changes
Other Study ID Numbers: 00014248
Study First Received: September 11, 2006
Last Updated: November 12, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Cesarean delivery
Placental removal
Blood loss

ClinicalTrials.gov processed this record on May 23, 2013