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

Tracking Information

First Received Date ^ICMJE

September 11, 2006

Last Updated Date

November 12, 2007

Start Date ^ICMJE

September 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Hematocrit levels (preoperatively and within 48 hours postoperatively)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00375986 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Pregnancy
Cesarean Section

Intervention ^ICMJE

Procedure: Manual placental removal at Cesarean delivery
Procedure: Spontaneous placental removal at Cesarean delivery

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

150

Completion Date

June 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00375986

Other Study ID Numbers ^ICMJE

00014248

Has Data Monitoring Committee

Responsible Party

Not Provided

Study Sponsor ^ICMJE

University of Rochester

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Eva K. Pressman, MD

University of Rochester

Information Provided By

University of Rochester

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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