Patient Attitudes Toward Ultrasound Measurement of Cervical Length

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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 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. Patients will be randomized into one of three groups: Standard US evaluation Sequential US evaluation Transvaginal cervical length screening 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. 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 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).

Official Title
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Patient Attitudes Regarding Abdominal Versus Transvaginal Ultrasonography for Assessment of the Cervical Length in Low Risk Patients: a Randomized Trial

Conditions
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Cervical Insufficiency

Intervention / Treatment
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* Procedure: Sequential ultrasound
* Procedure: Transvaginal ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: singleton gestation between 18-28 weeks Exclusion Criteria: presence of cerclage known short cervix prior preterm birth

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Ultrasound<br>Current standard of care - one abdominal view of the cervix to rule out placenta previa | |
| Experimental: Sequential Screen<br>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<br>* 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.<br>|
| Experimental: Screening Transvaginal Ultrasound<br>Obtain 3 adequate cervical length measurements using transvaginal ultrasound | Procedure: Transvaginal ultrasound<br>* Obtain 3 transvaginal ultrasound cervical length measurements<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Participants will complete a survey indicating their opinions about the ultrasound experience. | Assessed the day of the ultrasound (one single visit) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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short cervix, cervical shortening, preterm birth