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

Completed

• Conditions: Cervical Dilation
• Interventions: Diagnostic Test: Digital Cervical Exam; Diagnostic Test: Transperineal Ultrasound; Diagnostic Test: Transvaginal Ultrasound

• Registration Number: NCT05038891
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-09-02
• Study First Posted: 2021-09-09
• Study Start: 2021-09-13
• Primary Completion: 2022-09-01
• Study Completion: 2022-12-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Digital Cervical Assessment performed first	Digital Cervical Exam	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.
Ultrasound Assessment performed first	Digital Cervical Exam	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.
Digital Cervical Assessment performed first	Transperineal Ultrasound	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.
Ultrasound Assessment performed first	Transperineal Ultrasound	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.
Ultrasound Assessment performed first	Transvaginal Ultrasound	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.
Digital Cervical Assessment performed first	Transvaginal Ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Correlation of cervical examination between self-obtained ultrasound measurements and provider digital exam.	Data collection during induction of labor with image interpretation through end of study, assessed up to 6 months	Data collection will occur at up to five time points along a participant's labor course. Providers will be blinded to ultrasound images. Data includes provider digital exam, transperineal ultrasound cine clip with mean (anterior-posterior and transverse) measurement of internal os and total cervical length and transvaginal ultrasound cine clips with mean (anterior-posterior and transverse) measurement of internal os and total cervical length. Ultrasound images will be read by maternal-fetal medicine subspecialist blinded to patient information, labor stage and provider cervical examination.

Secondary Outcome Measures

Name	Time	Method
Participant-perceived discomfort after cervical examination using a 10 point Visual Analog Scale (VAS)	On day of induction after first cervical examination during first assessment, through study completion up to 6 months	The Visual Analog Scale values range from 0 to 10 where higher values indicate more pain and will be assessed once after the first cervical examination.
Participant anxiety levels will be measured via the Six-Item Spielberger State-Trait Anxiety Inventory (STAI-6)	On day of induction after first cervical examination during first assessment, through study completion up to 6 months	The 6 items which are on a 4 point likert scale will be administered to participants post first cervical exam. The 6 items are summed, divided by 6 and hen multiplied by 20 to give a range of 20 to 80. Higher scores indicate more anxiety.

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic Methodist Hospital; 🇺🇸 Rochester, Minnesota, United States