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

This study has been terminated.
(unable to recruit patients)
Sponsor:
Information provided by (Responsible Party):
John Uckele, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00711451
First received: July 2, 2008
Last updated: July 12, 2012
Last verified: July 2012
  Purpose

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)


Condition Intervention
Pregnancy
Cesarean Delivery
Behavioral: Manual removal
Procedure: Expressed removal

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

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Hemodynamic profile, especially Systemic Vascular Resistance [ Time Frame: immediately before and 24 hours after cesarean delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • development of postpartum preeclampsia [ Time Frame: within 1 week of delivery ] [ Designated as safety issue: No ]

Enrollment: 19
Study Start Date: July 2008
Study Completion Date: January 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: manual
Manual removal of placenta
Behavioral: Manual removal
Manual removal of placenta during cesarean delivery
Other Name: manual
Active Comparator: expressed
expressed placental removal
Procedure: Expressed removal
Surgeon will perform an expressed delivery of the placenta
Other Name: expressed

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711451

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Christian Bogner, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: John Uckele, Attending Physician, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00711451     History of Changes
Other Study ID Numbers: 2008-056
Study First Received: July 2, 2008
Last Updated: July 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
systemic vascular resistance
pregnancy
scheduled cesarean delivery
syncytiotrophoblast apoptosis
continuous wave Doppler

ClinicalTrials.gov processed this record on April 17, 2014