BACKGROUND
Pre-labor rupture of membranes occurs in 8% of pregnancies. In the absence of spontaneous
labor, induction of labor is considered an appropriate strategy for term pregnant
women with pre-labor rupture of membranes. There are several approaches for preinduction
cervical ripening, including mechanical methods, such as Foley catheterization, and
nonmechanical methods, such as oral misoprostol.
OBJECTIVE
This study aimed to evaluate and compare the effects of oral misoprostol and Foley
catheterization in pregnant women with pre-labor rupture of membranes at ≥34 weeks
of gestation who underwent induction of labor.
STUDY DESIGN
A randomized clinical trial was conducted. The inclusion criteria included nulliparous
and multiparous pregnant women at ≥34 weeks of gestation with singleton pregnancies,
cephalic presentation, and confirmed amniotic fluid leakage for more than 60 minutes.
A total of 104 participants were randomly allocated into 2 groups, one receiving sublingual
misoprostol and the other receiving transcervical Foley catheter 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 analysis of the umbilical cord.
RESULTS
The mean time from induction of labor to delivery (11.6±1.98 hours for Foley catheter
vs 10.16±2.35 hours for misoprostol; P=.007) and the median duration of cervical ripening (4.5 hours [interquartile range,
0.0–6.0] for Foley catheter vs 4.0 hours [interquartile range, 1.5–6.0] for misoprostol;
P=.04) were longer in the Foley catheter group than in the misoprostol group. There
was no statistically significant difference in the cesarean delivery rate between
the 2 groups (29.6% for Foley catheter vs 38.5% for misoprostol; P=.2). There was no case of chorioamnionitis or asphyxia in the 2 groups. There was
no significant difference between the 2 groups in terms of umbilical cord pH and the
1- and 5-minute Apgar scores (P=.1, P=.4, and P=.1); nevertheless, these values were higher in the Foley catheter group. There was
no statistically significant difference among additional secondary outcomes.
CONCLUSION
In pre-labor rupture of membranes cases, cervical ripening with a Foley catheter was
associated with a longer duration of ripening and time from induction to delivery
than cervical ripening with misoprostol. The cesarean delivery rate and the maternal
and neonatal infection rates were not different between these methods.
Key words
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Article info
Publication history
Published online: January 20, 2023
Accepted:
January 14,
2023
Received in revised form:
December 27,
2022
Received:
October 19,
2022
Footnotes
The authors report no conflict of interest.
This study received no funding.
The trial was registered with the Iranian Registry of Clinical Trials (identification number: IRCT20121224011862N4; https://www.irct.ir/search/result?query=IRCT20121224011862N4).
Cite this article as: Mokhtarpour S, Sahhaf F, Vahedi L, et al. Evaluation of mechanical and nonmechanical methods of cervix ripening in women with pre-labor rupture of membranes: a randomized controlled trial. Am J Obstet Gynecol MFM 2023;XX:x.ex–x.ex.
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