Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT00711451
Status:
TERMINATED
Last Update Posted:
2012-07-16
First Post:
2008-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Manual and Expressed Placental Removal at Cesarean Delivery and Its Effects on Various Cardiac Indices
Sponsor:
Corewell Health East
Organization:
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
unable to recruit patients
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: