Cervical Dilation
Conditions
Keywords
Cervical Effacement, Cervical Dilation, Labor, Pregnancy
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.
Interventions
DIAGNOSTIC_TESTDigital Cervical Exam
Standard Digital Cervical Exam by an experienced OB provider
DIAGNOSTIC_TESTTransperineal Ultrasound
Self-administered transperineal ultrasound after instruction by a health care professional
DIAGNOSTIC_TESTTransvaginal Ultrasound
Self-administered transvaginal ultrasound after instruction by a health care professional
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed