Patient Attitudes Toward Ultrasound Measurement of Cervical Length (TVUS)

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Insufficiency
• Intervention / Treatment: Procedure: Sequential ultrasound; Procedure: Transvaginal ultrasound

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).

• Study Type: Interventional
• Enrollment (Anticipated): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84177
      • Recruiting
      • Intermountain Medical Center
      • Contact: Stephanie T Romero, MD; Phone Number: 828-301-2711; Email: stephanie.romero@hsc.utah.edu
      • Principal Investigator: Stephanie T Romero, MD
      • Sub-Investigator: Michael S Esplin, MD
      • Sub-Investigator: Calla Holmgren, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• singleton gestation
• between 18-28 weeks

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Intermountain Women and Children's Research
• Investigators: Principal Investigator: Stephanie T Romero, MD, Intermountain Medical Center

Publications and helpful links

General Publications

• Esplin MS, O'Brien E, Fraser A, Kerber RA, Clark E, Simonsen SE, Holmgren C, Mineau GP, Varner MW. Estimating recurrence of spontaneous preterm delivery. Obstet Gynecol. 2008 Sep;112(3):516-23. doi: 10.1097/AOG.0b013e318184181a.
• Adams MM, Elam-Evans LD, Wilson HG, Gilbertz DA. Rates of and factors associated with recurrence of preterm delivery. JAMA. 2000 Mar 22-29;283(12):1591-6. doi: 10.1001/jama.283.12.1591.
• 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. doi: 10.1056/NEJM199602293340904.
• Hibbard JU, Tart M, Moawad AH. Cervical length at 16-22 weeks' gestation and risk for preterm delivery. Obstet Gynecol. 2000 Dec;96(6):972-8. doi: 10.1016/s0029-7844(00)01074-7.
• Hassan SS, Romero R, Vidyadhari D, Fusey S, Baxter JK, Khandelwal M, Vijayaraghavan J, Trivedi Y, Soma-Pillay P, Sambarey P, Dayal A, Potapov V, O'Brien J, Astakhov V, Yuzko O, Kinzler W, Dattel B, Sehdev H, Mazheika L, Manchulenko D, Gervasi MT, Sullivan L, Conde-Agudelo A, Phillips JA, Creasy GW; PREGNANT Trial. Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011 Jul;38(1):18-31. doi: 10.1002/uog.9017. Epub 2011 Jun 15.
• 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. doi: 10.1056/NEJMoa067815.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): December 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: November 25, 2011
• First Submitted That Met QC Criteria: November 28, 2011
• First Posted (Estimate): November 30, 2011

Study Record Updates

• Last Update Posted (Estimate): November 30, 2011
• Last Update Submitted That Met QC Criteria: November 28, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Keywords: preterm birth; short cervix; cervical shortening
• Additional Relevant MeSH Terms: Uterine Cervical Diseases; Uterine Diseases; Pregnancy Complications; Abortion, Habitual; Abortion, Spontaneous; Uterine Cervical Incompetence
• Other Study ID Numbers: sonographic cervical length

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No