DilaCheck Cervical Dilation Measurement Trial

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.

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.