N/A
N=42
DilaCheck Cervical Dilation Measurement Trial
Cervical Dilation · Labor Pain · Labor Fast · Labor; Irregular
Bottom Line
View on ClinicalTrials.gov: NCT03440723 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Interexaminer Agreement — 9; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DilaCheck (Device); Cervical dilation examination (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Elm Tree Medical Inc.
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Interexaminer Agreement |
9; 4 | — |
| SECONDARY Pain With Examination |
2.8; 3.1 | — |
| SECONDARY Ease of Use |
7 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03440723). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.