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Ultrasound Study of the Uterine Healing Process After Cesarean Delivery

Yale University logo

Yale University

Status

Completed

Conditions

Myometrial Remodeling

Treatments

Procedure: One- versus two-layer hysterotomy closure

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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