Manual and Expressed Placental Removal at Cesarean Delivery and Its Effects on Various Cardiac Indices

Not Applicable

Terminated

• Conditions: Cesarean Delivery; Pregnancy
• Interventions: Behavioral: Manual removal; Procedure: Expressed removal

• Registration Number: NCT00711451
• Lead Sponsor: William Beaumont Hospitals

Brief Summary

The purpose of this study is to evaluate whether manual removal of the placenta during a cesarean delivery results in higher changes in the resistance of blood flow throughout the body, also called systemic vascular resistance (SVR)

Detailed Description

Patients presenting to William Beaumont Hospital Royal Oak Labor and Delivery for a scheduled low transverse cesarean delivery will be asked to participate in a prospective, randomized study to evaluate any changes in systemic vascular resistance (SVR) pre- and post-delivery.

After obtaining informed consent, the patients will be randomized to one of two groups: group 1 will have manual removal of the placenta at cesarean section and group 2 will have expressed removal of the placenta at cesarean section.

Both groups will have a pre-operative continuous wave Doppler evaluation and a post-operative continuous wave Doppler evaluation at 24 hours after delivery. Continuous wave Doppler evaluation will be used pre- and post-operatively to evaluate any changes in SVR.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-02
• Study First Submitted QC: 2008-07-02
• Study First Posted: 2008-07-08
• Primary Completion: 2011-02
• Study Completion: 2012-01
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-12
• Last Update Posted: 2012-07-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 19

Inclusion Criteria

• pregnant
• scheduled for cesarean delivery
• able to give informed consent

Exclusion Criteria

• taking medications that may affect hemodynamics
• unable to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
manual	Manual removal	Manual removal of placenta
expressed	Expressed removal	expressed placental removal

Primary Outcome Measures

Name	Time	Method
Hemodynamic profile, especially Systemic Vascular Resistance	immediately before and 24 hours after cesarean delivery

Secondary Outcome Measures

Name	Time	Method
development of postpartum preeclampsia	within 1 week of delivery

Trial Locations

Locations (1)

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States