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TerminatedNCT00711451Updated Jul 16, 2012

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

An interventional study of Manual removal and Expressed removal in Pregnancy and Cesarean Delivery, sponsored by Corewell Health East. Terminated at 1 site in United States. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-16.

Sponsored by Corewell Health East · Not applicable, Interventional, and Treatment

Why this study was terminated
unable to recruit patients
Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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)

Read the 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.

02

Conditions studied

  • Pregnancy
  • Cesarean Delivery

Keywords

  • systemic vascular resistance
  • pregnancy
  • scheduled cesarean delivery
  • syncytiotrophoblast apoptosis
  • continuous wave Doppler
03

In context

Lead sponsor

Corewell Health East is the lead sponsor of 19 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • pregnant
  • scheduled for cesarean delivery
  • able to give informed consent

Exclusion criteria

Exclusion Criteria:

  • taking medications that may affect hemodynamics
  • unable to give informed consent
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Active comparator
    manual

    Manual removal of placenta

    Behavioral: Manual removal

  • Active comparator
    expressed

    expressed placental removal

    Procedure: Expressed removal

Interventions

  • BehavioralManual removal

    Manual removal of placenta during cesarean delivery

    Also known as: manual

  • ProcedureExpressed removal

    Surgeon will perform an expressed delivery of the placenta

    Also known as: expressed

06

What researchers measure

Primary outcomes

  1. Hemodynamic profile, especially Systemic Vascular Resistance

    Time frame: immediately before and 24 hours after cesarean delivery

Secondary outcomes

  1. development of postpartum preeclampsia

    Time frame: within 1 week of delivery

07

Study locations

1 site
  • William Beaumont Hospital
    Royal Oak, Michigan 48073, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00711451
Lead sponsor
Corewell Health East
Responsible party
John Uckele (Attending Physician, Corewell Health East) — Principal investigator
First posted
Jul 8, 2008
Start date
Jul 2008
Primary completion
Feb 2011
Completion
Jan 2012
Last update
Jul 16, 2012

Study contacts

Christian Bogner, MD
principal investigator · Corewell Health East

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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