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

July 12, 2012 updated by: John Uckele, William Beaumont Hospitals

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

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)

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: manual
Manual removal of placenta
Behavioral: Manual removal
Manual removal of placenta during cesarean delivery
Other Names:
  • manual
Active Comparator: expressed
expressed placental removal
Procedure: Expressed removal
Surgeon will perform an expressed delivery of the placenta
Other Names:
  • expressed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hemodynamic profile, especially Systemic Vascular Resistance
Time Frame: immediately before and 24 hours after cesarean delivery
immediately before and 24 hours after cesarean delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
development of postpartum preeclampsia
Time Frame: within 1 week of delivery
within 1 week of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Beaumont Hospitals

Investigators

  • Principal Investigator: Christian Bogner, MD, William Beaumont Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

July 2, 2008

First Submitted That Met QC Criteria

July 2, 2008

First Posted (Estimate)

July 8, 2008

Study Record Updates

Last Update Posted (Estimate)

July 16, 2012

Last Update Submitted That Met QC Criteria

July 12, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2008-056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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