Cervical Preparation for Same-Day Dilation & Evacuation

Launched by BOSTON MEDICAL CENTER · Jan 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different methods to prepare the cervix before a procedure called Dilation and Evacuation (D&E), which is used for second-trimester abortions. The goal is to find out if using a single-balloon catheter to soften and open the cervix is as effective as using osmotic dilators, which are another type of device used for the same purpose. The researchers will look at how long the procedure takes, how well each method works, how much pain participants feel, and overall satisfaction with their experience.

To participate in this trial, women need to be between 16 and 18 weeks pregnant and seeking a termination. They should be able to give informed consent and speak either English or Spanish. Participants will receive one of the two cervical preparation methods on the same day as their D&E procedure. It's important to note that women who have certain allergies, a high body mass index (BMI), or specific pregnancy complications may not be eligible for this study. Overall, this trial aims to ensure that women have a safe and effective option for cervical preparation before their procedure.

Gender

FEMALE

Eligibility criteria

• 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