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Ultrasound Study of the Uterine Healing Process After Cesarean Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00224250
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : March 13, 2018
Information provided by:
Yale University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Myometrial Remodeling Procedure: One- versus two-layer hysterotomy closure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Ultrasonographic Assessment of the Uterine Scarring Process Following Closure of the Uterus in One Versus Two Layer Technique.
Study Start Date : January 2005

Primary Outcome Measures :
  1. myometrial thickness

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00224250

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United States, Connecticut
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
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Principal Investigator: Benjamin Hamar, MD Yale University

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00224250    
Other Study ID Numbers: 27269
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018