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| Sponsored by: |
William Beaumont Hospitals |
|---|---|
| Information provided by: | William Beaumont Hospitals |
| ClinicalTrials.gov Identifier: | NCT00711451 |
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: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
manual: Active Comparator
Manual removal of placenta
|
Behavioral: Manual removal
Manual removal of placenta during cesarean delivery
|
|
expressed: Active Comparator
expressed placental removal
|
Procedure: Expressed removal
Surgeon will perform an expressed delivery of the placenta
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: John E Uckele, M.D. | 248-551-0610 | john.uckele@beaumont.edu |
| Contact: Evie Russell, R.N. | 248-898-2068 | evie.russell@beaumont.edu |
| United States, Michigan | |
| William Beaumont Hospital | Recruiting |
| Royal Oak, Michigan, United States, 48073 | |
| Contact: Evie Russell, RN 248-898-2068 Evie.Russell@beaumont.edu | |
| Contact: Christian Bogner, MD Christian.Bogner@beaumonthospitals.com | |
| Principal Investigator: Christian Bogner, MD | |
| Principal Investigator: | Christian Bogner, MD | William Beaumont Hospitals |
More Information
| Responsible Party: | William Beaumont Hospital ( Christian Bogner, M.D. ) |
| Study ID Numbers: | 2008-056 |
| Study First Received: | July 2, 2008 |
| Last Updated: | February 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00711451 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
systemic vascular resistance pregnancy scheduled cesarean delivery syncytiotrophoblast apoptosis continuous wave Doppler |
