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

NCT ID: NCT00711451

Last Updated: 2012-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-01-31

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.

Conditions

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Pregnancy Cesarean Delivery

Keywords

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systemic vascular resistance pregnancy scheduled cesarean delivery syncytiotrophoblast apoptosis continuous wave Doppler

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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manual

Manual removal of placenta

Group Type ACTIVE_COMPARATOR

Manual removal

Intervention Type BEHAVIORAL

Manual removal of placenta during cesarean delivery

expressed

expressed placental removal

Group Type ACTIVE_COMPARATOR

Expressed removal

Intervention Type PROCEDURE

Surgeon will perform an expressed delivery of the placenta

Interventions

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Manual removal

Manual removal of placenta during cesarean delivery

Intervention Type BEHAVIORAL

Expressed removal

Surgeon will perform an expressed delivery of the placenta

Intervention Type PROCEDURE

Other Intervention Names

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manual expressed

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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William Beaumont Hospitals

OTHER

Sponsor Role lead

Responsible Party

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John Uckele

Attending Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Bogner, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

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William Beaumont Hospital

Royal Oak, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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2008-056

Identifier Type: -

Identifier Source: org_study_id