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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00375986
Recruitment Status : Completed
First Posted : September 13, 2006
Last Update Posted : November 14, 2007
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment
Pregnancy Cesarean Section Procedure: Manual placental removal at Cesarean delivery Procedure: Spontaneous placental removal at Cesarean delivery

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Comparison of Manual vs. Spontaneous Removal of the Placenta at Cesarean Section
Study Start Date : September 2006
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

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




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.

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): 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

ClinicalTrials.gov Identifier: NCT00375986     History of Changes
Other Study ID Numbers: 00014248
First Posted: September 13, 2006    Key Record Dates
Last Update Posted: November 14, 2007
Last Verified: November 2007

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