Cervical Insufficiency Clinical Trial
— TVUSOfficial title:
Patient Attitudes Regarding Abdominal Versus Transvaginal Ultrasonography for Assessment of the Cervical Length in Low Risk Patients: a Randomized Trial
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.
Status | Unknown status |
Enrollment | 210 |
Est. completion date | December 2012 |
Est. primary completion date | December 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - singleton gestation - between 18-28 weeks Exclusion Criteria: - presence of cerclage - known short cervix - prior preterm birth |
Country | Name | City | State |
---|---|---|---|
United States | Intermountain Medical Center | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Intermountain Women and Children's Research |
United States,
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Fonseca EB, Celik E, Parra M, Singh M, Nicolaides KH; Fetal Medicine Foundation Second Trimester Screening Group. Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med. 2007 Aug 2;357(5):462-9. — View Citation
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Iams JD, Goldenberg RL, Meis PJ, Mercer BM, Moawad A, Das A, Thom E, McNellis D, Copper RL, Johnson F, Roberts JM. The length of the cervix and the risk of spontaneous premature delivery. National Institute of Child Health and Human Development Maternal Fetal Medicine Unit Network. N Engl J Med. 1996 Feb 29;334(9):567-72. — View Citation
Stone PR, Chan EH, McCowan LM, Taylor RS, Mitchell JM; SCOPE Consortium. Transabdominal scanning of the cervix at the 20-week morphology scan: comparison with transvaginal cervical measurements in a healthy nulliparous population. Aust N Z J Obstet Gynaecol. 2010 Dec;50(6):523-7. doi: 10.1111/j.1479-828X.2010.01225.x. Epub 2010 Sep 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time | 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. | Assessed on the day of ultrasound (one single visit) | |
Secondary | Patient satisfaction | Participants will complete a survey indicating their opinions about the ultrasound experience. | Assessed the day of the ultrasound (one single visit) | |
Secondary | Ultrasound adequacy | Assess the frequency with which adequate views of the cervix can be obtained using transabdominal vs transvaginal ultrasonography | Assessed on the day of the ultrasound (one single visit) |
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