NCT02912390

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

January 12, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2018

Completed
Last Updated

April 13, 2018

Status Verified

April 1, 2018

Enrollment Period

1.1 years

First QC Date

August 2, 2016

Last Update Submit

April 11, 2018

Conditions

Short Cervix, Twins

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • cervical length ≤ 15 mm.

    1 year

Other Outcomes (1)

  • cervical and vaginal microbiomes

    1 year

Study Arms (2)

Cerclage

ACTIVE COMPARATOR

\- Macdonald cerclage placed in standard fashion

Procedure: Cerclage

Expectant management

ACTIVE COMPARATOR

\- Patient is placed on activity restrictions

Other: Expectant management

Interventions

CerclagePROCEDURE

Macdonald cerclage placed in standard fashion

Cerclage
Expectant managementOTHER

placed on activity restrictions: no heavy lifting, frequent reclining, and pelvic rest.

Expectant management

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Mary's Health Center

St Louis, Missouri, 63117, United States

Location

MeSH Terms

Interventions

Cerclage, CervicalWatchful Waiting

Intervention Hierarchy (Ancestors)

Obstetric Surgical ProceduresSurgical Procedures, OperativeOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Laura Vricella, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 2, 2016

First Posted

September 23, 2016

Study Start

January 12, 2017

Primary Completion

March 1, 2018

Study Completion

April 11, 2018

Last Updated

April 13, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)