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Focal Myometrial Contractions: Impact on Cervical Assessment and Association With Voiding

NCT01513395 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2012-01-23

No results posted yet for this study

Summary

Focal myometrial (uterine) contractions occur in a substantial number of vaginal ultrasound examinations and can impede accurate cervical length measurement and placental location determination. The timing of bladder voiding is associated with the prevalence of focal myometrial contractions on vaginal ultrasound cervical assessment. We propose a blinded randomized-controlled trial of bladder voiding immediately before vaginal ultrasound for cervical assessment compared with no bladder voiding immediately before vaginal ultrasound in order to determine the prevalence of focal myometrial contractions during vaginal ultrasound cervical assessment and test whether timing of bladder voiding is associated with their incidence.

Conditions

  • Cervical Assessment
  • Focal Myometrial Contractions

Interventions

BEHAVIORAL

Interval bladder emptying

Participants randomized to the "Interval" arm (cervical assessment 15 minutes or more after voiding) will be notified of their allocation and asked to immediately use the rest room and attempt to void completely. A synchronized clock will be located in this restroom, and each participant will be asked to note the time that she completes voiding. This will be confirmed by the research staff by noting the time the participant enters and exits the restroom. The participant will return to the waiting room or ultrasound room. Any indicated trans-abdominal ultrasound imaging will be performed, and preparations will be made for the vaginal ultrasound. The participant will be asked not to void prior to the vaginal ultrasound. Cervical assessment will take place at a minimum of 15 minutes from voiding time.

Sponsors & Collaborators

Principal Investigators

  • Diana Rodriguez, MD, MPH · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-06-30
Completion
2013-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01513395 on ClinicalTrials.gov