Cerclage for Short Cervix in Twins
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|ClinicalTrials.gov Identifier: NCT02912390|
Recruitment Status : Terminated (On Internal Hold)
First Posted : September 23, 2016
Last Update Posted : April 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Short Cervix, Twins||Procedure: Cerclage Other: Expectant management||Not Applicable|
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
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cerclage for Ultrasound-Diagnosed Short Cervix in Twins: A Randomized Controlled Trial|
|Study Start Date :||January 12, 2017|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||April 11, 2018|
Active Comparator: Cerclage
- Macdonald cerclage placed in standard fashion
Macdonald cerclage placed in standard fashion
Active Comparator: Expectant management
- Patient is placed on activity restrictions
Other: Expectant management
placed on activity restrictions: no heavy lifting, frequent reclining, and pelvic rest.
- cervical length ≤ 25 mm. [ Time Frame: 1 year ]To determine whether cerclage placement in women with twin gestation and cervical length ≤ 25 mm results in pregnancy prolongation.
- cervical length ≤ 15 mm. [ Time Frame: 1 year ]To perform a planned subgroup analysis with adequate power to determine whether cerclage placement results in pregnancy prolongation in twins gestations with cervical length ≤ 15 mm.
- cervical and vaginal microbiomes [ Time Frame: 1 year ]To assess the cervical and vaginal microbiomes as well as presence of vaginal infections to determine potential predictors for spontaneous preterm birth in twin gestations with short cervix
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912390
|United States, Missouri|
|St. Mary's Health Center|
|Saint Louis, Missouri, United States, 63117|
|Principal Investigator:||Laura Vricella, MD||St. Louis University|