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NCT00711451 Clinical Trial

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

Pregnancy Clinical Trial

Official title:
Manual and Expressed Placental Removal at Planned Cesarean Delivery and Its Effects on Various Cardiac Indices as Measured By Continuous Wave Doppler Ultrasonography

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00711451
Other study ID # 2008-056
Secondary ID
Status Terminated
Phase N/A
First received July 2, 2008
Last updated July 12, 2012
Start date July 2008
Est. completion date January 2012

Study information
Verified date July 2012
Source William Beaumont Hospitals
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility
Status Terminated
Enrollment 19
Est. completion date January 2012
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• Manual removal
Manual removal of placenta during cesarean delivery
Procedure:
• Expressed removal
Surgeon will perform an expressed delivery of the placenta

Locations
Country Name City State
United States William Beaumont Hospital Royal Oak Michigan

Sponsors (1)
Lead Sponsor Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hemodynamic profile, especially Systemic Vascular Resistance immediately before and 24 hours after cesarean delivery No
Secondary development of postpartum preeclampsia within 1 week of delivery No
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