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Ultrasound Study of the Uterine Healing Process After Cesarean Delivery

Not Applicable
Completed
Conditions
Myometrial Remodeling
Registration Number
NCT00224250
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
30
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
myometrial thickness
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Yale-New Haven Hospital

🇺🇸

New Haven, Connecticut, United States

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