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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:
ClinicalTrials.gov Identifier:
NCT00711451
First Posted: July 8, 2008
Last Update Posted: July 16, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
John Uckele, William Beaumont Hospitals
  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
Intervention Model: Parallel Assignment
Masking: None (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 John Uckele, William Beaumont Hospitals:

Primary Outcome Measures:
  • Hemodynamic profile, especially Systemic Vascular Resistance [ Time Frame: immediately before and 24 hours after cesarean delivery ]

Secondary Outcome Measures:
  • development of postpartum preeclampsia [ Time Frame: within 1 week of delivery ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: John Uckele, Attending Physician, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00711451     History of Changes
Other Study ID Numbers: 2008-056
First Submitted: July 2, 2008
First Posted: July 8, 2008
Last Update Posted: July 16, 2012
Last Verified: July 2012

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