Recruiting

Observational Study

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT01513395

Conditions

Cervical Assessment

Focal Myometrial Contractions

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Interval bladder emptying

Study Details

Brief 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

Study ID

NCT01513395

Start date

Jan, 2012

Status verified date

Jan, 2012

Completion date

Nov, 2013

Anticipated

Primary completion date

Jun, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Gestational age of 14+0/7 through 31+6/7 weeks
  • Presenting for obstetric ultrasound in the MFMU for cervical assessment and/or placental location determination
  • Verbal consent
  • Ability to refrain from urination for at least 15 minutes
  • Age 18 years or greater

Exclusion Criteria:

  • N/A

Study Design

Enrollment

112 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Immediate

Participants randomized to the "Immediate" or control arm (voiding within five minutes of cervical assessment), will undergo any indicated trans-abdominal ultrasound imaging and preparations for vaginal ultrasound (including readying the probe and preparing the exam table for lithotomy position) prior to using the restroom. The participant will be instructed to proceed to the restroom to empty her bladder completely. A synchronized clock will be placed in the restroom, and the patient 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. Vaginal ultrasound and cervical assessment will then be performed immediately upon return to the ultrasound room (within a maximum of 5 minutes from voiding time).

experimental: Interval

Participants randomized to the "Interval" or experimental 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

Interventions

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.

Primary outcome measure

  • Presence of focal myometrial contraction [ Time Frame: Throughout the duration of that ultrasound examination (minutes) ]

Central Contacts and Locations

Central contacts

William T Schnettler, MD

513-290-0900wschnett@bidmc.harvard.edu

Diana Rodriguez, MD, MPH

drodrig4@bidmc.harvard.edu

Locations

BIDMC - Dept. of Obstetrics and Gynecology

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

William T Schnettler, MD

513-290-0900wschnett@bidmc.harvard.edu

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Jan 23, 2012

Last verified

Jan, 2012

Keywords

  • Cervical assessment
  • Focal myometrial contractions

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2012-01-23.