Patient Attitudes Toward Ultrasound Measurement of Cervical Length

NCT01482039 | Unknown

• 1 other identifier: Sonographic Cervical Length
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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. 1.Patient satisfaction with ultrasound experience as measured by patient questionnaire
2. 2.Number of adequate views of the cervix obtained with each approach
3. 3.Time required to obtain views of the cervix
4. 4.Time from initiation of exam to completion of cervical assessment
5. 5.Time for completion of entire exam
6. 6.Patient satisfaction
7. 7.Comfort/Discomfort of exam procedure
8. 8.Overall impression of exam process
9. 9.Number of adequate views of the cervix obtained

Conditions

Cervical Insufficiency

Keywords

short cervix; cervical shortening; preterm birth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient satisfaction

  Assessed the day of the ultrasound (one single visit)

• Ultrasound adequacy

  Assessed on the day of the ultrasound (one single visit)

Study Arms (3)

Standard Ultrasound

NO INTERVENTION

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

Sequential Screen

EXPERIMENTAL

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

Screening Transvaginal Ultrasound

EXPERIMENTAL

Obtain 3 adequate cervical length measurements using transvaginal ultrasound

Procedure: Transvaginal ultrasound

Interventions

Sequential ultrasound PROCEDURE

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.

Sequential Screen

Transvaginal ultrasound PROCEDURE

Obtain 3 transvaginal ultrasound cervical length measurements

Screening Transvaginal Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• singleton gestation
• between 18-28 weeks

You may not qualify if:

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

Sponsors & Collaborators

• Intermountain Women and Children's Research: lead

Study Sites (1)

Intermountain Medical Center

Salt Lake City, Utah, 84177, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 18757647 BACKGROUND

• 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.

  PMID: 10735396 BACKGROUND

• 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.

  PMID: 8569824 BACKGROUND

• 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.

  PMID: 11084188 BACKGROUND

• 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.

  PMID: 21472815 BACKGROUND

• 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.

  PMID: 17671254 BACKGROUND

• 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.

  PMID: 21133862 BACKGROUND

MeSH Terms

Conditions

Uterine Cervical Incompetence; Premature Birth

Condition Hierarchy (Ancestors)

Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Abortion, Habitual; Abortion, Spontaneous; Pregnancy Complications; Genital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Stephanie T Romero, MD

  Intermountain Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie T Romero, MD

CONTACT

828-301-2711; stephanie.romero@hsc.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2011
• First Posted: November 30, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 30, 2011

Record last verified: 2011-11

Locations

US (1)