Patient Attitudes Toward Ultrasound Measurement of Cervical Length (TVUS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Intermountain Women and Children's Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Stephanie T. Romero, Intermountain Women and Children's Research
ClinicalTrials.gov Identifier:
NCT01482039
First received: November 25, 2011
Last updated: November 28, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Cervical Insufficiency
Procedure: Sequential ultrasound
Procedure: Transvaginal ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Patient Attitudes Regarding Abdominal Versus Transvaginal Ultrasonography for Assessment of the Cervical Length in Low Risk Patients: a Randomized Trial

Further study details as provided by Intermountain Women and Children's Research:

Primary Outcome Measures:
  • Time [ Time Frame: Assessed on the day of ultrasound (one single visit) ] [ Designated as safety issue: No ]
    The time it takes to perform the assessment of the cervix will be recorded, as well as the time it takes to perform the entire exam.


Secondary Outcome Measures:
  • Patient satisfaction [ Time Frame: Assessed the day of the ultrasound (one single visit) ] [ Designated as safety issue: No ]
    Participants will complete a survey indicating their opinions about the ultrasound experience.

  • Ultrasound adequacy [ Time Frame: Assessed on the day of the ultrasound (one single visit) ] [ Designated as safety issue: No ]
    Assess the frequency with which adequate views of the cervix can be obtained using transabdominal vs transvaginal ultrasonography


Estimated Enrollment: 210
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: 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.
Experimental: Screening Transvaginal Ultrasound
Obtain 3 adequate cervical length measurements using transvaginal ultrasound
Procedure: Transvaginal ultrasound
Obtain 3 transvaginal ultrasound cervical length measurements

Detailed Description:

BACKGROUND AND SIGNIFICANCE

Preterm birth is a significant problem in the United States and worldwide. Approximately twelve percent of births in the US occur before 37 weeks and are considered preterm. Of these, 80% are considered "spontaneous preterm deliveries" (as opposed to iatrogenic) and are related to preterm labor or preterm rupture of membranes (Arias, 2003). Certain pregnancy characteristics have been identified to determine those patients at risk for preterm delivery. These include a history of preterm birth (Esplin, 2008), uterine anomalies, multiple gestation, among other things, both modifiable and not (Gardosi, 2000; Ananth, 2006). However, an important risk factor that can be identified is the presence of specific changes in the cervix, such as cervical shortening, and in fact, studies indicate that the risk of spontaneous preterm birth increases as cervical length decreases (Iams, 1996; Hibbard, 2000).

Some authors now advocate the universal screening of all pregnant women for cervical shortening at the time of the ultrasound that is performed at 18-28 weeks in most women. However, the best approach to evaluate the cervix in low risk patients (those without an identifiable risk factor) remains controversial.

PROTOCOL

  1. Patients will be identified in the Maternal Fetal Medicine office and consented for randomization at the time of presentation for previously scheduled mid-trimester ultrasound
  2. Patients will be given randomly generated treatment allocations within sealed opaque envelopes. Once a patient has consented to enter the trial, the envelope will be opened by the ultrasonographer to determine the assigned treatment regimen.
  3. Patients will be randomized into one of three groups:

    1. Standard US evaluation
    2. Sequential US evaluation
    3. Transvaginal cervical length screening
  4. Maternal demographics including maternal age, height, weight, parity, and gestational age will be collected from the patient as part of the patient questionnaire. Ultrasound exam data including measurements of the fetal biometry, presence of fetal anomalies, placental location and amniotic fluid volume will be collected from the official ultrasound report.

    1. Patients will be assigned a unique study ID number at the time of enrollment and all information including time of ultrasound procedures, clinical data and adequacy of cervical measurement will be linked by the ID number
    2. All data will be entered into an electronic data base in a de-identified fashion and kept in a secure, encrypted web-based database management program (RedCap).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • singleton gestation
  • between 18-28 weeks

Exclusion Criteria:

  • presence of cerclage
  • known short cervix
  • prior preterm birth
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01482039

Contacts
Contact: Stephanie T Romero, MD 828-301-2711 stephanie.romero@hsc.utah.edu

Locations
United States, Utah
Intermountain Medical Center Recruiting
Salt Lake City, Utah, United States, 84177
Contact: Stephanie T Romero, MD    828-301-2711    stephanie.romero@hsc.utah.edu   
Principal Investigator: Stephanie T Romero, MD         
Sub-Investigator: Michael S Esplin, MD         
Sub-Investigator: Calla Holmgren, MD         
Sponsors and Collaborators
Intermountain Women and Children's Research
Investigators
Principal Investigator: Stephanie T Romero, MD Intermountain Medical Center
  More Information

Publications:

Responsible Party: Stephanie T. Romero, Principal Investigator, Intermountain Women and Children's Research
ClinicalTrials.gov Identifier: NCT01482039     History of Changes
Other Study ID Numbers: Sonographic Cervical Length
Study First Received: November 25, 2011
Last Updated: November 28, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Intermountain Women and Children's Research:
short cervix
cervical shortening
preterm birth

ClinicalTrials.gov processed this record on August 21, 2014