Skip to main content
OpenTrials
Completed

NCT Number: NCT00224250

Ultrasound Study of the Uterine Healing Process After Cesarean Delivery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myometrial Remodeling

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale-New Haven Hospital

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

One- versus two-layer hysterotomy closure

Procedure

Primary outcomes

  1. myometrial thickness

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2005
First posted
Sep 22, 2005
Registry last updated
Mar 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.