Clinical trial NCT01513395: Focal Myometrial Contractions: Impact on Cervical Assessment and Association With Voiding
Official title: Focal Myometrial Contractions: Impact on Cervical Assessment and Association With Voiding. A Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Assessment
Focal Myometrial Contractions
Keywords: Cervical assessment
Focal myometrial contractions
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2012-01-20
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Presence of focal myometrial contraction
timeFrame: Throughout the duration of that ultrasound examination (minutes)
Secondary outcomes:
measure: Location of focal myometrial contractions
timeFrame: Throughout the duration of that ultrasound examination (minutes)
Other outcomes:
Locations:
city: Boston
country: United States
facility: BIDMC - Dept. of Obstetrics and Gynecology
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Diana Rodriguez, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schnettler W, March M, Hacker MR, Modest AM, Rodriguez D. Impaired ultrasonographic cervical assessment after voiding: a randomized controlled trial. Obstet Gynecol. 2013 Apr;121(4):798-804. doi: 10.1097/AOG.0b013e3182860b8d.