Evaluation of mechanical and non-mechanical methods of cervix ripening in women with PROM: A randomized clinical trial

Published:January 20, 2023DOI:



      Premature rupture of membranes (PROM) occurs in 8% of pregnancies. In the absence of spontaneous labor, induction of labor is considered an appropriate strategy for term pregnant women with PROM. There are several approaches for pre-induction cervical ripening, including mechanical methods, such as Foley catheterization, and non-mechanical methods, such as oral misoprostol.


      The purpose of this study was to evaluate and compare the effects of oral misoprostol and Foley catheterization in pregnant women with PROM ≥34w who underwent induction of labor.

      Study design

      A randomized clinical trial was performed. Inclusion criteria were nullipar and multipar pregnant women ≥ 34 weeks of gestational age (GA), singleton pregnancies with cephalic presentation with confirmed amniotic fluid leakage for more than 60 minutes. A total of 104 participants were randomly allocated into two groups, one receiving sublingual misoprostol (miso) and the other receiving transcervical Foley catheter (FC) for cervical ripening. The primary outcome was time from intervention to delivery, and the secondary outcomes included delivery method, maternal and neonatal results (chorioamnionitis, Apgar score, neonatal sepsis and asphyxia), and arterial blood gas (ABG) analysis of the umbilical cord.


      The mean time from induction to delivery (11.6 ± 1.98 for FC vs. 10.16 ± 2.35 hours for miso, P=0.007) and the median duration of cervical ripening (4.5 (0.0-6.0) for FC vs. 4.0 (1.5-6.0) hours for miso, P=0.04) was longer in the FC group. There was no statistically significant difference in the cesarean delivery rate between the two groups (29.6% for FC vs 38.5% for miso, P=0.2). There were no cases of chorioamnionitis or asphyxia in the two groups. There was no significant difference between the two groups in terms of umbilical cord pH, and the first and fifth minute Apgar scores (P=0.1, P=0.4, and P=0.1); nevertheless, these values were higher in the FC group. There were no statistically significant differences among additional secondary outcomes.


      Cervical ripening in PROM cases with FC is associated with longer duration of ripening and time from induction to delivery compared to ripening with misoprostol. The cesarean delivery rate and the maternal and neonatal infection rates were not different between these methods.


      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to American Journal of Obstetrics & Gynecology MFM
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect