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Sequential Screen for Cervical Insufficiency (TVUS Trial)

N/A
Waitlist Available
Led By Stephanie T Romero, MD
Research Sponsored by Intermountain Women and Children's Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed on the day of the ultrasound (one single visit)
Awards & highlights

TVUS Trial Summary

The investigators propose a prospective evaluation of methods to assess cervical length for uncomplicated singleton gestations between 18-28 weeks presenting to the MFM office for routine mid pregnancy ultrasound. The investigators hypothesize that a sequential approach to screening of the cervix (which consists of initial transabdominal evaluation first with transvaginal ultrasound reserved only for those patients in whom the cervix appears short on transabdominal exam or when adequate views cannot be obtained with the transabdominal approach alone) will take less time, will result in the same number of adequate views of the cervix and will have higher patient satisfaction that a universal transvaginal screening approach. OBJECTIVE To determine the best strategy for cervical length screening in uncomplicated singleton gestations between the gestational ages of 18-28 weeks. Primary outcome: 1) Time required to obtain adequate views of the cervical length. Secondary outcomes: Patient satisfaction with ultrasound experience as measured by patient questionnaire Number of adequate views of the cervix obtained with each approach STUDY DESIGN This is a prospective study to compare strategies for cervical length measurements in uncomplicated singleton gestations seen in the MFM office for routine mid pregnancy fetal well being ultrasound between 18-28 weeks gestation. The different strategies include 1) Transabdominal assessment of the cervix (current standard), 2) Sequential evaluation of the cervical length (transabdominal followed by transvaginal if necessary due to short cervix or inadequate transabdominal views), and 3) Transvaginal cervical length assessment. Patients with an uncomplicated singleton gestation presenting for a routine mid pregnancy ultrasound between 18-28 weeks will be randomized into one of the three groups noted above after consent is obtained. Ultrasound examination will then take place and data collected. The various strategies listed above will be compared for the following: Time required to obtain views of the cervix Time from initiation of exam to completion of cervical assessment Time for completion of entire exam Patient satisfaction Comfort/Discomfort of exam procedure Overall impression of exam process Number of adequate views of the cervix obtained Maternal demographics including age, parity, weight, height and due date/gestational age will also be obtained for all consenting patients.

Eligible Conditions
  • Cervical Insufficiency

TVUS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed on the day of ultrasound (one single visit)
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed on the day of ultrasound (one single visit) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time
Secondary outcome measures
Patient satisfaction
Ultrasound adequacy

TVUS Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Sequential ScreenExperimental Treatment1 Intervention
Start with 3 abdominal views of the cervix with measurement. If 3 adequate views cannot be obtained, or if measurement is less than 3cm, then will perform transvaginal scan for measurement.
Group II: Screening Transvaginal UltrasoundExperimental Treatment1 Intervention
Obtain 3 adequate cervical length measurements using transvaginal ultrasound
Group III: Standard UltrasoundActive Control1 Intervention
Current standard of care - one abdominal view of the cervix to rule out placenta previa
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transvaginal ultrasound
2013
Completed Phase 3
~1780

Find a Location

Who is running the clinical trial?

Intermountain Women and Children's ResearchLead Sponsor
Stephanie T Romero, MDPrincipal InvestigatorIntermountain Medical Center

Frequently Asked Questions

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~16 spots leftby May 2025