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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Beth Israel Deaconess Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
William Schnettler, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01513395
First received: January 17, 2012
Last updated: January 20, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Cervical Assessment
Focal Myometrial Contractions
Behavioral: Interval bladder emptying

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Focal Myometrial Contractions: Impact on Cervical Assessment and Association With Voiding. A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Presence of focal myometrial contraction [ Time Frame: Throughout the duration of that ultrasound examination (minutes) ] [ Designated as safety issue: No ]

    Focal myometrial contraction as defined by transvaginal ultrasound findings:

    • Thickening of the myometrial portion of the uterine wall visualized as two distinctly different areas of echogenicity
    • An unusually long-appearing cervix (possibly more than 50 mm) with an S-shaped endocervical canal and apparent internal os located appreciably cephalad
    • Asymmetric anterior and posterior lower uterine segment widths cephalad to apparent internal os
    • The thickening is transient.


Secondary Outcome Measures:
  • Location of focal myometrial contractions [ Time Frame: Throughout the duration of that ultrasound examination (minutes) ] [ Designated as safety issue: No ]

    The location of focal myometrial contractions in relation to the internal cervical os is defined by:

    • Distance from internal os to caudal-most portion of focal myometrial contraction (measured with a curved line)..
    • Proportion that lie immediately adjacent to the internal cervical os.


Estimated Enrollment: 112
Study Start Date: January 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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.

Detailed Description:

This blinded randomized-controlled trial will be performed through the Division of Maternal Fetal Medicine at Beth Israel Deaconess Medical Center. We will offer enrollment to any pregnant woman at gestational weeks 14+0/7 through 31+6/7 presenting for obstetric ultrasound where cervical assessment and/or placental location determination is indicated. Patient positioning and image acquisition will follow a standard protocol and will be performed by the co-investigators. Outcome ascertainment will be performed by two co-investigators blinded to participant allocation upon completion of data collection. Demographic and obstetrical outcome data will be collected via review of the medical record. Analysis of primary and secondary outcomes will yield incidence data, and comparisons will be made between groups.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01513395

Contacts
Contact: William T Schnettler, MD 513-290-0900 wschnett@bidmc.harvard.edu
Contact: Diana Rodriguez, MD, MPH drodrig4@bidmc.harvard.edu

Locations
United States, Massachusetts
BIDMC - Dept. of Obstetrics and Gynecology Recruiting
Boston, Massachusetts, United States, 02215
Contact: William T Schnettler, MD    513-290-0900    wschnett@bidmc.harvard.edu   
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Diana Rodriguez, MD, MPH Beth Israel Deaconess Medical Center
  More Information

No publications provided by Beth Israel Deaconess Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: William Schnettler, Fellow in Maternal Fetal Medicine, Instructor, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01513395     History of Changes
Other Study ID Numbers: 2011-P-000425/2 BIDMC
Study First Received: January 17, 2012
Last Updated: January 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Cervical assessment
Focal myometrial contractions

ClinicalTrials.gov processed this record on September 18, 2014