NCT00711451

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)

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable pregnancy

Timeline
Completed

Started Jul 2008

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 2, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 8, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

July 16, 2012

Status Verified

July 1, 2012

Enrollment Period

2.6 years

First QC Date

July 2, 2008

Last Update Submit

July 12, 2012

Conditions

PregnancyCesarean Delivery

Keywords

systemic vascular resistancepregnancyscheduled cesarean deliverysyncytiotrophoblast apoptosiscontinuous wave Doppler

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic profile, especially Systemic Vascular Resistance

    immediately before and 24 hours after cesarean delivery

Secondary Outcomes (1)

  • development of postpartum preeclampsia

    within 1 week of delivery

Study Arms (2)

manual

ACTIVE COMPARATOR

Manual removal of placenta

Behavioral: Manual removal

expressed

ACTIVE COMPARATOR

expressed placental removal

Procedure: Expressed removal

Interventions

Manual removalBEHAVIORAL

Manual removal of placenta during cesarean delivery

Also known as: manual
manual
Expressed removalPROCEDURE

Surgeon will perform an expressed delivery of the placenta

Also known as: expressed
expressed

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Interventions

Gene Expression

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

  • Christian Bogner, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

July 2, 2008

First Posted

July 8, 2008

Study Start

July 1, 2008

Primary Completion

February 1, 2011

Study Completion

January 1, 2012

Last Updated

July 16, 2012

Record last verified: 2012-07

Locations

US(1)