Ultrasound Study of the Uterine Healing Process After Cesarean Delivery

March 9, 2018 updated by: Yale University

Ultrasonographic Assessment of the Uterine Scarring Process Following Closure of the Uterus in One Versus Two Layer Technique.

Our hypothesis is that there is no difference in the healing process in those women who have a one- or two-layer uterine closure at the time of cesarean delivery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We are recruiting women who are presenting for their first (primary) cesarean delivery. They will be randomized to one- or two-layer myometrial closure at the time of their cesarean delivery. Ultrasound will be used to serially assess the myometrial thickness and myometrial remodeling process.

Study Type

Interventional

Enrollment

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale-New Haven Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • singleton gestation
  • term pregnancy
  • Kerr uterine incision employed
  • age > 18

Exclusion Criteria:

  • Pain score > 4
  • Current cesarean delivery for non-reassuring fetal status or other emergent situation (eg. maternal bleeding, etc.)
  • Prior cesarean section
  • Prior uterine surgery
  • Hysterotomy other than Kerr (low transverse) incision in current cesarean
  • Extension of the uterine incision in current cesarean
  • Multifetal pregnancy
  • Maternal diabetes mellitus
  • Maternal connective tissue disorder
  • Uterine malformation
  • Uterine myomas (fibroids) in the anterior lower uterine segment
  • Chorioamnionitis
  • Non-English speaking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
myometrial thickness

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Benjamin Hamar, MD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 9, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 27269

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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