Comparison of outpatient with inpatient mifepristone usage for cervical ripening: study protocol for a randomized controlled trial

Background: The proportion of women who undergo labor induction steadily increases due to the increasing number of indications. Most inductions of labor are carried out in inpatient settings. However, outpatient induction may be more convenient to women and cheaper for health service providers. Mifepristone as a cervical ripening agent is rapidly gaining popularity. However, the current literature is lacking regarding the outcomes of its use in outpatient settings. It is also essential to compare clinical outcomes from outpatient with inpatient mifepristone for induction of labor. The present study aimed to evaluate the efficacy and safety of outpatient versus inpatient mifepristone for labor induction. Materials and methods: This is a protocol for a randomized, prospective, open-label clinical trial. Primiparous and multiparous women (n=300) with a singleton pregnancy with fetus in the cephalic presentation at the gestational age between 39 and 41+6 weeks, cervical Bishop’s score 6 or less, indications for labor induction, who meet all inclusion criteria, none of the exclusion criteria, and sign an informed consent form will be randomly allocated to one of two groups (outpatient and inpatient). The two groups will receive a standard protocolized cervical ripening with mifepristone (one or two doses). Discussion: We expect outpatient management with mifepristone to be as effective and safe as an inpatient while increasing economic benefit and patients’ compliance during cervical ripening. Trial registration: isrctn.com. ISRCTN26164110. Registered on February 21th, 2020.

RU486, mifepristone, RU486, antiprogestin, induction of labor, outpatient labor induction, randomized trial