NCT02912390

Cerclage for Short Cervix in Twins

Cerclage for Ultrasound-Diagnosed Short Cervix in Twins: A Randomized Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: St. Louis University · Academic / Other
• Sex: Female
• Age: 14 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Short Cervix, Twins

Interventions

Type	Name	Description
PROCEDURE	Cerclage	Macdonald cerclage placed in standard fashion
OTHER	Expectant management	placed on activity restrictions: no heavy lifting, frequent reclining, and pelvic rest.

Timeline

• Start date: 2017-01-12
• Primary completion: 2018-03-01
• Completion: 2018-04-11
• First posted: 2016-09-23
• Last updated: 2018-04-13

Locations

1 site across 1 country: United States