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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
Sponsor:
Information provided by (Responsible Party):
Laura Vricella, MD, St. Louis University

Brief 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

Condition or disease Intervention/treatment Phase
Short Cervix, Twins Procedure: Cerclage Other: Expectant management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Missouri
St. Mary's Health Center
Saint Louis, Missouri, United States, 63117
Sponsors and Collaborators
St. Louis University
Investigators
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Principal Investigator: Laura Vricella, MD St. Louis University
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Responsible Party: Laura Vricella, MD, Assistant Professor, St. Louis University
ClinicalTrials.gov Identifier: NCT02912390    
Other Study ID Numbers: 27073a
Cerclage in Twins ( Other Identifier: Saint Louis University Institutional Review Board )
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: April 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No