Exploring Outpatient Induction of Labor with Oral Misoprostol

User involvement, Safety, Feasibility, and Women’s Perspectives

Sammendrag

Background: Induction of labor (IOL) rates have increased markedly worldwide over the past decades, becoming one of the most common obstetric interventions in high-income countries. In Norway, nearly 30% of all births are induced. Concurrently, there is a growing emphasis on woman-centered care, user involvement, and the importance of a positive birth experience. Outpatient IOL using low-dose oral misoprostol has been proposed as a way to reduce pressure on maternity wards while supporting women’s preferences. However, evidence on its safety, feasibility, and acceptability is limited.
Aim: The overall aim of the Labor Induction INpatient and Outpatient (LINO) project was to investigate outpatient IOL using low-dose oral misoprostol by assessing its medical safety and feasibility, and women’s perspectives. Specifically, we aimed to: Pre-study: Develop a PhD project based on verified knowledge gapsand user priorities through a Needs Led Research process. Study 1: Assess the proportion of women eligible for outpatient IOL,report safety outcomes, and assess the efficacy of the IOL processes ofthe eligible pregnancies. Study 2: Evaluate the clinical outcomes and feasibility of implementing oral misoprostol in the outpatient IOL protocol in a Norwegian setting. Study 3: Explore and describe women’s real-time reflections on what is important to them during induction of labor.
Methods: The thesis includes a pre-study and three original studies. In the prestudy, we conducted a Needs Led Research process, combining literature review and user involvement to identify and prioritize research needs. In Study 1, we applied outpatient IOL criteria to a 7-month historical cohort to assess the safety and feasibility of outpatient care. In Study 2, we tested outpatient IOL in clinical settings through a prospective cohort study, with women self-allocating to either outpatient or inpatient care. In Study 3, a qualitative study, we analyzed in-themoment reflections from women collected once a day throughout their IOL process. Results: The pre-study informed the development of the main aim and sub aims for the LINO project. In study 1, including 1,320 women, 29.7% met the eligibility criteria for outpatient IOL. Serious adverse events before or in early labor were rare. The average duration from initiation of IOL to administration of the last misoprostol tablet was 22.4 hours. In Study 2, including 212 women, no births occurred outside the hospital or within 30 minutes of admission. Adverse events were rare, with no significant differences in safety outcomes between the outpatient and inpatient groups. Women in the outpatient group had significantly shorter pre-labor hospital stays (median 12.3 vs. 28.1 hours), and 76% of the women in this group completed the misoprostol treatment at home. Study 3 included 146 women from Study 2. Through the analysis of the women’s reflections, we identified three main categories: demanding mental processes, the crucial role of supportive relationships, and essential practical needs. The overarching theme was the need to feel secure facing the unfamiliar and life-altering experience of childbirth. Conclusions: We found no evidence suggesting that outpatient IOL using low-dose oral misoprostol is unsafe in low-risk pregnancies in resource-rich settings as in Norway. However, current evidence is limited, and larger studies are needed for definitive conclusions. Although outpatient IOL may not fully address the resource challenges posed by rising IOL rates, it provides a valuable expansion of women's options during IOL. However, it is not suitable for all, and a woman-centered approach, including shared decision-making, clear eligibility criteria, and structured follow-up, is essential to ensure safety and a high quality of care.