Need for cervical dilation prior to second-trimester uterine procedures Pregnancy and Childbirth
Conditions
Interventions
This is an open-label, single-arm feasibility study of a 14 mm intracervical balloon radial dilation device (M360-CDD-001-14) in participants at 13–16 weeks’ gestation planning a second-trimester uter
intravenous sedation is provided per site standard of care. The balloon is inflated with sterile water and then deflated and removed.
Cervical dilation is assessed after balloon removal. The planned
if dilation is inadequate or not tolerated, standard cervical preparation methods are used. Treatment consists of a single procedural episode, with a safety follow-up contact 3–7 days after device use
Sponsors
Medicines360
Eligibility
Sex/Gender
Female
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed study consent 2. Healthy females 18 years old or more at the time of enrollment 3. Unwanted pregnancy or fetal demise at 13 0/7 to 16 0/7 weeks gestation/gestational size 4. Desiring uterine evacuation and signed procedure consent before signing study informedconsent 5. BMI <40.0 kg/m^2 6. English speakers and readers
Exclusion criteria
Exclusion criteria: 1. Prior failed uterine evacuation attempt in the current pregnancy 2. Known cervical stenosis 3. Coagulopathy or current use of anticoagulants 4. Use of misoprostol within 48 hours prior to enrollment 5. Study staff or a member of the immediate family of a study staff 6. Any condition or circumstance that, in the opinion of the Investigator, would constitute contraindications to study participation, compromise the participant’s ability to comply with the study protocol, or interfere with data collection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful cervical dilation measured using adequate dilation that is tolerated by the participant throughout the radial dilation process and does not require further cervical preparation (e.g., medications or rigid dilation) prior to uterine evacuation, assessed at end of study visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Participant pain assessment measured using participant-reported pain assessment questions at during and immediately after device use at the enrollment visit;Investigator assessment of ease of use and participant tolerance of the device measured using investigator-completed assessment questions at following completion of the cervical dilation attempt;Adverse events and adverse device effects associated with balloon cervical dilation measured using clinical assessment and participant report from device use at the safety follow-up contact (3–7 days post-procedure) | — |
Countries
Canada
Contacts
Public ContactMitch Creinin
Outcome results
None listed