The Safety of Two Different Oral Misoprostol Dosing Strategies for Labor Preinduction at Term: A Single-Center Retrospective Cohort Study

<b>Background/Objectives:</b> Preinduction of labor is commonly performed in women with unfavorable cervical conditions at term. Oral misoprostol is increasingly used due to its ease of administration and effectiveness; however, optimal dosing regimens remain under investigation. This study aimed to evaluate the safety and effectiveness of two oral misoprostol regimens (25 µg every 2 h versus 50 µg every 4 h) for preinduction of labor in term pregnancies. <b>Methods:</b> This single-center retrospective cohort study included 270 women with singleton term pregnancies who underwent oral misoprostol preinduction. Women received either 25 µg every 2 h (<i>n</i> = 60) or 50 µg every 4 h (<i>n</i> = 210) according to routine clinical protocols. Data were collected from electronic medical records and included demographic and obstetric characteristics, labor course, need for additional interventions (e.g., Foley catheter), and neonatal outcomes. The primary outcome was a composite maternal and neonatal safety endpoint. Secondary outcomes included mode of delivery, need for Foley catheter use, and time to delivery. <b>Results:</b> Both regimens were effective in facilitating labor progression. In crude analysis, the need for additional cervical ripening with a Foley catheter was higher in the 50 µg group compared with the 25 µg group (37.1% vs. 21.7%, <i>p</i> = 0.037); however, after stratification by prelabor rupture of membranes (PROM), this difference was no longer statistically significant (<i>p</i> = 0.39). Cesarean section rates did not differ significantly between groups (29.0% vs. 20.0%, <i>p</i> = 0.22). The time from the last misoprostol dose to delivery was shorter in the 50 µg group, but the difference was not statistically significant (<i>p</i> = 0.17). Neonatal outcomes, including birthweight, Apgar scores, and umbilical cord blood gas parameters, were comparable between groups. No severe maternal or neonatal adverse events were recorded. <b>Conclusions:</b> In this single-center retrospective cohort study, the 25 μg every 2 h and 50 μg every 4 h oral misoprostol regimens were associated with comparable obstetric and neonatal outcomes within the analyzed parameters. No significant differences in recorded maternal or neonatal safety outcomes were observed. Selection of the dosing regimen should take into account individual clinical factors, including parity, cervical status, and membrane status.

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Journal
Journal of Clinical Medicine
Published
2026-03-22
DOI
https://doi.org/10.3390/jcm15062425
Primary Topic
Maternal and Perinatal Health Interventions
Type
article
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article

The Safety of Two Different Oral Misoprostol Dosing Strategies for Labor Preinduction at Term: A Single-Center Retrospective Cohort Study

Julia Rogalska, Witold Kędzia, Magdalena Adamczyk, Paulina Mularczyk et al.
Journal of Clinical Medicine
Maternal and Perinatal Health Interventions
article

The Safety of Two Different Oral Misoprostol Dosing Strategies for Labor Preinduction at Term: A Single-Center Retrospective Cohort Study

Julia Rogalska, Witold Kędzia, Magdalena Adamczyk, Paulina Mularczyk, Małgorzata Kędzia
article en

Abstract

<b>Background/Objectives:</b> Preinduction of labor is commonly performed in women with unfavorable cervical conditions at term. Oral misoprostol is increasingly used due to its ease of administration and effectiveness; however, optimal dosing regimens remain under investigation. This study aimed to evaluate the safety and effectiveness of two oral misoprostol regimens (25 µg every 2 h versus 50 µg every 4 h) for preinduction of labor in term pregnancies. <b>Methods:</b> This single-center retrospective cohort study included 270 women with singleton term pregnancies who underwent oral misoprostol preinduction. Women received either 25 µg every 2 h (<i>n</i> = 60) or 50 µg every 4 h (<i>n</i> = 210) according to routine clinical protocols. Data were collected from electronic medical records and included demographic and obstetric characteristics, labor course, need for additional interventions (e.g., Foley catheter), and neonatal outcomes. The primary outcome was a composite maternal and neonatal safety endpoint. Secondary outcomes included mode of delivery, need for Foley catheter use, and time to delivery. <b>Results:</b> Both regimens were effective in facilitating labor progression. In crude analysis, the need for additional cervical ripening with a Foley catheter was higher in the 50 µg group compared with the 25 µg group (37.1% vs. 21.7%, <i>p</i> = 0.037); however, after stratification by prelabor rupture of membranes (PROM), this difference was no longer statistically significant (<i>p</i> = 0.39). Cesarean section rates did not differ significantly between groups (29.0% vs. 20.0%, <i>p</i> = 0.22). The time from the last misoprostol dose to delivery was shorter in the 50 µg group, but the difference was not statistically significant (<i>p</i> = 0.17). Neonatal outcomes, including birthweight, Apgar scores, and umbilical cord blood gas parameters, were comparable between groups. No severe maternal or neonatal adverse events were recorded. <b>Conclusions:</b> In this single-center retrospective cohort study, the 25 μg every 2 h and 50 μg every 4 h oral misoprostol regimens were associated with comparable obstetric and neonatal outcomes within the analyzed parameters. No significant differences in recorded maternal or neonatal safety outcomes were observed. Selection of the dosing regimen should take into account individual clinical factors, including parity, cervical status, and membrane status.

Journal of Clinical MedicineVol. 15(6)
Poznan University of Medical Sciences (PL)
Decent work and economic growth
Openalex Percentile: Top 9%
Maternal and Perinatal Health Interventions
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