Short Cervix, Twins Clinical Trial
Official title:
Cerclage for Ultrasound-Diagnosed Short Cervix in Twins: A Randomized Controlled Trial
Through cervical length measurement in uncomplicated twin gestations, women with cervical length ≤ 25 mm will be approached for randomization to cerclage placement or expectant management with activity restriction and treatment of preterm labor
Pregnant women with twin gestations are screened for short cervix with transvaginal cervical
length measurements as part of routine care at St. Mary's Health Center (SMHC) and Saint
Louis University's (SLUCare) Physician Group. (Transvaginal cervical length measurement every
2 weeks from 16weeks/0days-23weeks/6days weeks, per hospital practice) Women pregnant with
twin gestations at SMHC who meet study criteria will undergo transvaginal length screening
between 16 and 24 weeks gestation. Those women with transvaginal cervical length measurements
at or below 25 mm will be approached for study participation.
If a patient agrees to participate in the trial, they will be randomized in 1:1 fashion to
cerclage vs. expectant management.
Participants found to have a vaginal infection by cultures performed at randomization will be
treated with appropriate antibiotics per usual institutional practices
Cerclage arm:
- Macdonald cerclage placed in standard fashion: mersilene suture preferred for
standardization
Expectant management arm:
- Patient is placed on activity restrictions: no heavy lifting, frequent reclining, and
pelvic rest.
If a participant does not consent to participate in the trial, permission to collect their
outcome information in an observational manner will be requested.
The neonatal medical record will be reviewed for outcome data on twins, weights,
complications, neonatal intensive care unit (NICU) stay, to 28 day after discharge.
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