- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02912390
Cerclage for Short Cervix in Twins
Cerclage for Ultrasound-Diagnosed Short Cervix in Twins: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Missouri
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Saint Louis, Missouri, United States, 63117
- St. Mary's Health Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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.
Time Frame: 1 year
|
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.
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.
|
1 year
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laura Vricella, MD, St. Louis University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Short Cervix, Twins
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Universitaire Ziekenhuizen KU LeuvenUnknownMonochorionic TwinsBelgium
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Juniper Pharmaceuticals, Inc.Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedPreterm Delivery | Short Cervix | Short Uterine Cervical LengthUnited States, Israel, Belarus, Chile, Czech Republic, India, Italy, Russian Federation, South Africa, Ukraine
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University of PennsylvaniaCompletedPremature Birth | Short CervixUnited States
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Université de SherbrookeCHU de Quebec-Universite Laval; Centre hospitalier de l'Université de Montréal... and other collaboratorsCompletedPreterm Birth | Short CervixCanada
-
Mỹ Đức HospitalMy Duc Phu Nhuan Hospital HCMC, Vietnam; Quang Ninh Obstetrics and Pediatrics...Unknown
-
University of PennsylvaniaCompletedPreterm Birth | Short CervixUnited States
-
Hillel Yaffe Medical CenterUnknown
-
Stanford UniversityCompleted
Clinical Trials on Cerclage
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Aarhus University HospitalOdense University Hospital; Oslo University Hospital; Rigshospitalet, Denmark; Hvidovre... and other collaboratorsNot yet recruitingPreterm Birth | Cervical Insufficiency
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Stony Brook UniversityRecruitingThe Primary Outcome is Preterm Delivery Before 28 Weeks Gestational Age Compared to Women With One vs Two Cerclages PlacedUnited States
-
Obstetrix Medical GroupTerminatedFetal Membranes, Premature RuptureUnited States
-
Zagazig UniversityRecruitingPreterm Birth | Twin Pregnancy With Antenatal Problem | Cervical ShorteningEgypt
-
Zagazig UniversityRecruitingPreterm Birth | Twin Pregnancy, Antepartum Condition or Complication | Cervical CerclageEgypt
-
Quanta MedicalCousin BiotechRecruiting
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University of AarhusCompletedCervical Insufficiency | Pre-Term
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Rambam Health Care CampusUnknown
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Eunice Kennedy Shriver National Institute of Child...University of Alabama at BirminghamCompletedLabor, PrematureUnited States