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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy, Cesarean Delivery

Intervention / Treatment
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* Behavioral: Manual removal
* Procedure: Expressed removal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: manual<br>Manual removal of placenta | Behavioral: Manual removal<br>* Manual removal of placenta during cesarean delivery<br>* Other names: manual;|
| Active Comparator: expressed<br>expressed placental removal | Procedure: Expressed removal<br>* Surgeon will perform an expressed delivery of the placenta<br>* Other names: expressed;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of postpartum preeclampsia |  | within 1 week of delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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systemic vascular resistance, pregnancy, scheduled cesarean delivery, syncytiotrophoblast apoptosis, continuous wave Doppler