Clinical trial NCT05038891: Self-Obtained Ultrasound Scans for Measurement of Cervical Dilation and Effacement in Labor
Official title: Self-Obtained Transperineal and Transvaginal Ultrasound Scans for Measurement of Cervical Dilation and Effacement in Labor: Implications for Telemedicine and Home Hospital in Obstetrics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervical Dilation
Keywords: Cervical Effacement
Cervical Dilation
Labor
Pregnancy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This pilot study will enroll pregnant women undergoing induction of labor at the Family Birth Center at Mayo Clinic Hospital in Rochester, MN. The target population will include women with a singleton fetus at gestational age greater than 28 weeks 0 days gestation who have intact membrane status at time of induction of labor.

Brief summary: This is a pilot study to test the accuracy and comfort of self-directed ultrasound imaging of cervical dilation and effacement in pregnant women undergoing induction of labor. The study will assess correlation of cervical measurements between self-directed imaging and experienced provider digital cervical examinations.

Detailed description: The primary objective will assess correlation of cervical measurements with gold standard of provider digital cervical examinations and self-obtained transperineal and transvaginal images. Experienced providers performing digital cervical examinations will be blinded to ultrasound images and measurements. The maternal-fetal medicine subspecialist interpreting the ultrasound images will be blinded to patient details and will document ultrasound measurement of cervical dilation of the internal cervical os as the mean of anterior-posterior and transverse measurements and cervical length. 2-D ultrasound images and cine clips will be obtained at up to five different time points during the induction of labor.

As as secondary objective, participant discomfort and anxiety will be measured following the initial set of cervical measurements using the Visual Analog Scale and Six-Item State-Trait Anxiety Inventory.

Eligibility criteria: Inclusion Criteria:

* Pregnant females age 18 years or older
* Third trimester of pregnancy with a singleton fetus (gestational age \>28 weeks)
* Pre-gestational body mass index \<40
* Scheduled for induction of labor
* Eligible for induction of labor based on current birth center guidelines
* Intact membranes when presenting for induction of labor

Exclusion Criteria:

* History of prior cervical loop electrosurgical excisional procedure or cold knife conization
* Cerclage placement during current pregnancy
* Positive COVID-19 test within 7 days of admission for induction of labor
* Fever \> 38.0 C at time of admission for induction of labor

Primary outcomes:
measure: Correlation of cervical examination between self-obtained ultrasound measurements and provider digital exam.
timeFrame: Data collection during induction of labor with image interpretation through end of study, assessed up to 6 months
Secondary outcomes:
measure: Participant-perceived discomfort after cervical examination using a 10 point Visual Analog Scale (VAS)
timeFrame: On day of induction after first cervical examination during first assessment, through study completion up to 6 months
measure: Participant anxiety levels will be measured via the Six-Item Spielberger State-Trait Anxiety Inventory (STAI-6)
timeFrame: On day of induction after first cervical examination during first assessment, through study completion up to 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Methodist Hospital
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Regan N Theiler, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Megan Miller, M.D.
role: STUDY_CHAIR
References: