Self-Obtained Ultrasound Scans for Measurement of Cervical Dilation and Effacement in Labor

Mayo Clinic

Status: Completed

Conditions: Cervical Dilation

Treatments: Diagnostic Test: Transperineal Ultrasound; Diagnostic Test: Digital Cervical Exam; Diagnostic Test: Transvaginal Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT05038891

21-004735

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Digital Cervical Assessment performed first

Description:

A digital cervical exam will be performed by an experienced senior obstetrics and gynecology resident, using index finger and middle finger to measure the dilation and thickness of the cervix. This is the gold standard measurement utilized to assess the labor course. In this group, the digital cervical exam is done first, followed by a participant-performed ultrasound imaging assessment of the cervix.

Treatment:

Diagnostic Test: Transvaginal Ultrasound

Diagnostic Test: Transperineal Ultrasound

Diagnostic Test: Digital Cervical Exam

Ultrasound Assessment performed first

Description:

Ultrasound imaging will be first taught by an experienced RN, then self-performed by the participant in the presence of junior obstetrics and gynecology resident and the RN. The junior resident will ensure the ultrasound device is functioning properly and the images are saved. In this group, the participant-performed imaging assessment is done first, followed by a digital cervical exam performed by an experienced senior obstetrics and gynecology resident.

Treatment:

Diagnostic Test: Transvaginal Ultrasound

Diagnostic Test: Transperineal Ultrasound

Diagnostic Test: Digital Cervical Exam