Abstract
Objective
This study aimed to investigate the effectiveness and safety of a method combining double-balloon catheter for cervical ripening and intravenous drip of oxytocin on the induction of term labor, providing the reference for clinical safety.
Methods
A total of 120 pregnant women with a gestation between 37+0 and 41+6 weeks, indications of labor induction, singleton pregnancy with cephalic presentation were enrolled. The patients were divided into the research group receiving cervical dilation balloon combined with intravenous drip of oxytocin and the control group receiving an intravenous drip of oxytocin at a concentration of 0.5% for labor induction (n = 60 for each). The effectiveness and safety of labor induction were evaluated by the rates of successful cervical ripening promotion and labor induction, as well as the vaginal delivery rate, induced labor time, total duration of labor, the total amount of postpartum hemorrhage within 24 h after giving birth, the incidences of postpartum hemorrhage, cervical laceration, puerperal infection and neonatal outcomes.
Results
There was no statistical difference in the basal demographic and clinical characteristics, including ages, gestational weeks, delivery times and Bishop scores at admission between two groups. The rate of successful cervical ripening promotion (research vs. control = 90.00% vs. 55.00%), the rate of successful induction (95.00% vs. 40.00%), the vaginal delivery rate (93.33% vs. 63.33%), the induced labor time (15.03 ± 5.40 vs. 30.68 ± 10.82 h), and the total duration of labor (8.12 ± 2.65 vs. 15.01 ± 6.06 h) were significantly different between two groups (all P < 0.05). There was no significant difference in the total amount of postpartum hemorrhage, incidences of postpartum hemorrhage, cervical laceration, puerperal infection as well as the neonatal outcomes, including neonatal weight, neonatal asphyxia and incidence of meconium aspiration syndrome between two groups.
Conclusions
Compared to labor induction of oxytocin, the method combining double-balloon catheter for cervical ripening and intravenous drip of oxytocin for the induction of term labor has a higher vaginal delivery rate, shorter total duration of labor, and does not increase the incidences of postpartum hemorrhage and neonatal infection, which is a more effective and safer method for induction of term labor.
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Funding
This study was supported by the grants from the Nature Science Foundation of China (81470015 and 81670256), the Science and Technology Project of Special Funds of Guangzhou (2014J4100168), Guangdong Science and Technology Project (2016A020216005, 2015B090903063 and 2015A020212006), the Natural Science Foundation of Guangdong Province (2014A030313079) and Guangzhou Science and Technology Project (201510010052).
Conflict of interest
The authors declare that they have no conflict of interest.
Ethical approval
This study was approved by the institutional review board of Longgang District Center Hospital of Shenzhen.
Informed consent
Informed consent was obtained from all individual participants included in the study.
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Wu, X., Wang, C., Li, Y. et al. Cervical dilation balloon combined with intravenous drip of oxytocin for induction of term labor: a multicenter clinical trial. Arch Gynecol Obstet 297, 77–83 (2018). https://doi.org/10.1007/s00404-017-4564-9
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DOI: https://doi.org/10.1007/s00404-017-4564-9