Clinical trial NCT03440723: DilaCheck Cervical Dilation Measurement Trial
Official title: Inter-examiner Agreement of a Novel Device for the Measurement of Cervical Dilation in Labor: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Dilation
Labor Pain
Labor Fast
Labor; Irregular
Keywords: Cervical Dilation
Dilation
Sterile vaginal examination
Lead sponsor: Elm Tree Medical Inc.
Sponsor class: INDUSTRY
Collaborators: name: Thomas Jefferson University
First posted: 2018-02-22
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial in which participants are randomly assigned to one of two arms, control or treatment
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Trial to compare the interexaminer agreement between two cervical dilation examinations conducted by Labor and Delivery physicians when using standard methods versus DilaCheck device.

Detailed description: The trial seeks to compare the DilaCheck device with standard digital cervical dilation examinations. 50 laboring female participants will be enrolled with 25 randomly assigned to the control arm and 25 to the treatment (DilaCheck) arm. Each participant will receive two cervical dilation examinations from two separate physicians. The main outcome measure is agreement between the two cervical dilation measurements. Secondary outcomes include ease of use of the device and pain levels.

Eligibility criteria: Inclusion Criteria:

* The research population is pregnant women in the first stage of labor. Subjects eligible for inclusion in the study must be: pregnant women who are admitted to a Labor and Delivery unit for management or induction of labor in the first stage of labor, are able to give informed consent, are 18 years of age or greater, speak English, and have a gestational age greater than or equal to 37 weeks (i.e. term pregnancy). Patients are only consented if they have adequate pain control, either because they are not yet in labor (i.e. are admitted for an induction of labor) or have a functioning epidural.

Exclusion Criteria:

* Exclusion criteria include progression to the second stage of labor (i.e. known dilation of ten centimeters), known rupture of membranes, any condition that renders labor unsafe for the patient (e.g. cardiac conditions, pulmonary hypertension) and any other condition that necessitates an emergent or urgent cesarean section (e.g. non-reassuring fetal status, placental abruption, hemorrhage, cord prolapse). All participants are necessarily female due to the subject matter. Given the vulnerability of pregnant patients under the age of 18, this study will exclude children. There are no restrictions on eligibility based on race or ethnicity.

Primary outcomes:
measure: Interexaminer Agreement
timeFrame: Immediate upon examination
Secondary outcomes:
measure: Pain With Examination
timeFrame: Immediate within 5 minutes of examinations
measure: Ease of Use
timeFrame: Upon conclusion of the trial, <3 months from time of last examination with device
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
References:
citation: Martin EL, Firman B, Berghella V. Novel device vs manual examinations for the measurement of cervical dilation in labor: a randomized controlled trial. Am J Obstet Gynecol MFM. 2021 May;3(3):100328. doi: 10.1016/j.ajogmf.2021.100328. Epub 2021 Feb 11.