NCT00375986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Sep 2006

Shorter than P25 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

November 14, 2007

Status Verified

November 1, 2007

First QC Date

September 11, 2006

Last Update Submit

November 12, 2007

Conditions

PregnancyCesarean Section

Keywords

Cesarean deliveryPlacental removalBlood loss

Outcome Measures

Primary Outcomes (1)

  • Hematocrit levels (preoperatively and within 48 hours postoperatively)

Secondary Outcomes (4)

  • Number of units of blood transfused intraoperatively and postoperatively

  • Development of uterine infection (endometritis)

  • Length of postoperative hospital stay

  • Operative time

Interventions

Manual placental removal at Cesarean deliveryPROCEDURE
Spontaneous placental removal at Cesarean deliveryPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Prematurity (\<37 weeks)
  • Preoperative chorioamnionitis
  • Vaginal delivery of fetus
  • Emergency Cesarean Delivery
  • Patient's OB not agreeable to participating in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Strong Memorial Hospital

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Eva K. Pressman, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2006

First Posted

September 13, 2006

Study Start

September 1, 2006

Study Completion

June 1, 2007

Last Updated

November 14, 2007

Record last verified: 2007-11

Locations

US(1)