NCT02372422

Brief Summary

The purpose of this study is to determine if the use of routine transvaginal cervical length ultrasound can be used to prevent preterm deliveries in twin gestations.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Oct 2002

Longer than P75 for not_applicable pregnancy

Status
completed

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

Study Start

First participant enrolled

October 1, 2002

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
Last Updated

February 26, 2015

Status Verified

February 1, 2015

Enrollment Period

3.7 years

First QC Date

February 15, 2015

Last Update Submit

February 20, 2015

Conditions

Pregnancy

Keywords

TwinsTwin gestationPreterm birthPrevention

Outcome Measures

Primary Outcomes (1)

  • Gestational age at delivery

    Gestational age reported as completed weeks of gestation

    Immediately at the time of delivery

Secondary Outcomes (8)

  • Preterm birth at < 35 completed weeks of gestation

    Immediately at the time of delivery

  • Number of days of maternal bed rest

    Immediately at the time of delivery

  • Number of maternal days in the hospital

    Immediately at the time of delivery

  • Use of tocolytic medications

    Immediately at the time of delivery

  • Administration of steroids

    Immediately at the time of delivery

  • +3 more secondary outcomes

Study Arms (2)

Transvaginal Cervical Length Group

EXPERIMENTAL

Clinicians managing the patients were aware of the transvaginal cervical length ultrasound measurements.

Other: Transvaginal ultrasound determination of cervical length

Routine Care

OTHER

Clinicians managing the patients were not aware of any transvaginal cervical length ultrasound measurements.

Other: Routine care

Interventions

Transvaginal ultrasound determination of cervical lengthOTHER

Transvaginal ultrasound was used to measure the length of the cervix from the internal to external os relying on a standard approach and clinicians caring for the patients were made aware of the results.

Transvaginal Cervical Length Group
Routine careOTHER

Routine prenatal care of twins. Digital exams were permitted, but transvaginal ultrasound assessment of cervical length was not.

Routine Care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Twin pregnancy
  • Gestational age \< 20 weeks

You may not qualify if:

  • History of incompetent cervix with plans to place a cerclage
  • History of possible cervical incompetence with preexisting plans to monitor cervical length
  • Prior preterm birth at \< 28 weeks gestational age
  • Plans to leave the area before delivery
  • Known major fetal anomaly
  • Known diagnosis of twin-twin transfusion syndrome
  • Age \< 18
  • Monoamniotic twins

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Michael C Gordon, M.D.

    59th Medical Wing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
William H. Barth, Jr., M.D., Col(ret), USAF, MC

Study Record Dates

First Submitted

February 15, 2015

First Posted

February 26, 2015

Study Start

October 1, 2002

Primary Completion

June 1, 2006

Study Completion

July 1, 2007

Last Updated

February 26, 2015

Record last verified: 2015-02