Cerclage for Short Cervix in Twins

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

Study Overview

• Status: Terminated
• Conditions: Short Cervix, Twins
• Intervention / Treatment: Procedure: Cerclage; Other: Expectant management

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63117
      • St. Mary's Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 43 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cerclage; - Macdonald cerclage placed in standard fashion	Procedure: Cerclage; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: St. Louis University
• Investigators: Principal Investigator: Laura Vricella, MD, St. Louis University

Study record dates

Study Major Dates

• Study Start: January 12, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): April 11, 2018

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: September 21, 2016
• First Posted (Estimate): September 23, 2016

Study Record Updates

• Last Update Posted (Actual): April 13, 2018
• Last Update Submitted That Met QC Criteria: April 11, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 27073a; Cerclage in Twins (Other Identifier: Saint Louis University Institutional Review Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No