Myometrial Remodeling
Conditions
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.
Interventions
PROCEDUREOne- versus two-layer hysterotomy closure
Sponsors
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| myometrial thickness | — |
Countries
United States
Outcome results
None listed