Recruiting

Observational Study

Sponsor:

Intermountain Women and Children's Research

Code:

NCT01482039

Conditions

Cervical Insufficiency

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Sequential ultrasound

Transvaginal ultrasound

Study Details

Brief 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:

1. Patient satisfaction with ultrasound experience as measured by patient questionnaire
2. 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:

1. Time required to obtain views of the cervix

1. Time from initiation of exam to completion of cervical assessment
2. Time for completion of entire exam
2. Patient satisfaction

1. Comfort/Discomfort of exam procedure
2. Overall impression of exam process
3. 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.

Conditions

Cervical Insufficiency

Study ID

NCT01482039

Start date

Nov, 2011

Status verified date

Nov, 2011

Completion date

Dec, 2012

Anticipated

Primary completion date

Dec, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • singleton gestation
  • between 18-28 weeks

Exclusion Criteria:

  • presence of cerclage
  • known short cervix
  • prior preterm birth

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

no intervention: Standard Ultrasound

Current standard of care - one abdominal view of the cervix to rule out placenta previa

experimental: Sequential Screen

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.

experimental: Screening Transvaginal Ultrasound

Obtain 3 adequate cervical length measurements using transvaginal ultrasound

Interventions

Sequential ultrasound

Abdominal ultrasound first; obtain 3 adequate measurements. If 3 adequate views not obtained or if measurement less than 3 cm, perform transvaginal ultrasound for measurement.

Transvaginal ultrasound

Obtain 3 transvaginal ultrasound cervical length measurements

Primary outcome measure

  • Time [ Time Frame: Assessed on the day of ultrasound (one single visit) ]

Central Contacts and Locations

Central contacts

Locations

Intermountain Medical Center

Recruiting

Salt Lake City, Utah, United States, 84177

Contacts

Principal Investigator:

Stephanie T Romero, MD

More Information

Sponsor

Intermountain Women and Children's Research

Last update posted

Nov 30, 2011

Last verified

Nov, 2011

Keywords

  • short cervix
  • cervical shortening
  • preterm birth

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Intermountain Women and Children's Research on 2011-11-30.