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CompletedNCT00224250Updated Mar 13, 2018

Ultrasound Study of the Uterine Healing Process After Cesarean Delivery

An interventional study of One- versus two-layer hysterotomy closure in Myometrial Remodeling, sponsored by Yale University. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-13.

Sponsored by Yale University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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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Conditions studied

  • Myometrial Remodeling
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In context

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single
Enrollment
30 participants

Interventions

  • ProcedureOne- versus two-layer hysterotomy closure
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What researchers measure

Primary outcomes

  1. myometrial thickness

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Study locations

1 site
  • Yale-New Haven Hospital
    New Haven, Connecticut 06511, United States
08

References and documents

Publications

  • Hamar BD, Saber SB, Cackovic M, Magloire LK, Pettker CM, Abdel-Razeq SS, Rosenberg VA, Buhimschi IA, Buhimschi CS. Ultrasound evaluation of the uterine scar after cesarean delivery: a randomized controlled trial of one- and two-layer closure. Obstet Gynecol. 2007 Oct;110(4):808-13. doi: 10.1097/01.AOG.0000284628.29796.80. PubMed 17906013 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00224250
Lead sponsor
Yale University
First posted
Sep 22, 2005
Start date
Jan 2005
Last update
Mar 13, 2018

Study contacts

Benjamin Hamar, MD
principal investigator · Yale University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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