Cervical ripening balloon for same day cervical preparation for second trimester abortion
Abortion
Awarded 2025
Uta Landy Complex Family Planning Scholars
Gabrielle Taper, MD
University of New Mexico
$7,500

Gabrielle Taper, MD is a Complex Family Planning fellow at the University of New Mexico. She completed her medical education at UTHealth Houston, and her residency at the University of Texas at Austin.

In this study, we propose a randomized controlled trial of cervical preparation method via cervical ripening balloon and buccal misoprostol (experimental group) versus cervical preparation with osmotic dilators and buccal misoprostol (standard care) for same-day outpatient abortion. The purpose of this study is to determine the feasibility, acceptability, and safety profile of using a cervical ripening balloon for cervical preparation for same-day outpatient abortion via dilation and evacuation (D&E) between 18 weeks 0 days and 19 weeks 6 days gestation. We hypothesize that cervical ripening balloons plus misoprostol are non-inferior to osmotic dilators with misoprostol (standard care) when comparing D&E procedure length and additionally are well-tolerated in the outpatient setting. Recruitment, consent and procedures for eligible participants will occur at the University of New Mexico Center for Reproductive Health. The primary outcome will be length of time for procedure completion. Secondary outcomes will focus on safety factors including estimated blood loss and complications, as well as, patient and physician satisfaction. A sample size of 24 (12 per arm) will detect a difference of 10 minutes with 80% power and an alpha of 2.5%; We intend to recruit 36 participants to ensure statistical power and to give the possibility to more robustly evaluate secondary outcomes.