Cerclage for Short Cervix in Twins

Short Cervix, Twins Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02912390
• Other study ID #: 27073a
• Secondary ID: Cerclage in Twin
• Status: Terminated
• Phase: N/A
• First received: August 2, 2016
• Last updated: April 11, 2018
• Start date: January 12, 2017
• Est. completion date: April 11, 2018

Study information

• Verified date: April 2018
• Source: St. Louis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: April 11, 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 45 Years

Eligibility

Inclusion Criteria:

• at least 14 years of age, but less than 55 yrs of age

• must be able to read and write English

• must be able to give informed consent.

• Twin pregnancy

Exclusion Criteria:

• Women with a serious physical or mental illness or condition that would substantially interfere with participation in the study

• membrane prolapse beyond the external cervical os,

• major fetal anomaly in either twins will be excluded from randomization.

Related Conditions & MeSH terms

• Short Cervix, Twins

Intervention

Procedure:
• Cerclage
Macdonald cerclage placed in standard fashion

Other:
• Expectant management
placed on activity restrictions: no heavy lifting, frequent reclining, and pelvic rest.

Locations

Country	Name	City	State
United States	St. Mary's Health Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
St. Louis University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cervical and vaginal microbiomes	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	1 year
Primary	cervical length = 25 mm.	To determine whether cerclage placement in women with twin gestation and cervical length = 25 mm results in pregnancy prolongation.	1 year
Secondary	cervical length = 15 mm.	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.	1 year