Ultrasound Study of the Uterine Healing Process After Cesarean Delivery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Myometrial Remodeling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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One- versus two-layer hysterotomy closure

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes