Overview
This is a noninferiority randomized control trial of two cervical preparation methods prior to same-day Dilation & Evacuation (D&E). Cervical preparation is a process that softens and dilates the cervix prior to a procedure.
The primary objective is to evidence noninferiority of cervical preparation using a single-balloon catheter method when compared to a group receiving osmotic dilators, specifically in D&E operative time.
Secondary objectives will compare the two methods for adequate dilation, ability to complete the operation in the same day, participant pain, satisfaction and safety.
Eligibility
Inclusion Criteria:
- Between 16 weeks 0 days - 18 weeks 6 days gestational age who are pursuing termination, based on reliable gestational age (defined as ultrasonography performed by a clinical provider, or a certain last menstrual period)
- Able to provide informed consent
- English- or Spanish-speaking
- Singleton intrauterine pregnancy
Exclusion Criteria:
- Allergy to betadine, aquacryl hydrogel, latex-free silicone single-balloon catheter, synthetic or natural osmotic dilators
- Fetal demise or known fetal anomaly
- BMI >45
- Incarceration or other inability to give informed consent
- Decide to undergo cervical preparation overnight prior to next-day D&E