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Comparative Study
. 2025 Mar 15;25(1):295.
doi: 10.1186/s12884-025-07375-9.

Clinical comparison of vaginal misoprostol combined with a foley balloon versus vaginal misoprostol alone for inducing labor: a prospective cohort study

Rui Zheng  1 , Lijia Du  1 , Xiaoxiong Zhu  1 , Xiaoying Zhang  1 , Weihua Han  2 , Zhifen Yang  3
Affiliations
Comparative Study

Clinical comparison of vaginal misoprostol combined with a foley balloon versus vaginal misoprostol alone for inducing labor: a prospective cohort study

Rui Zheng et al. BMC Pregnancy Childbirth. .

Abstract

Objective: To compare the induction-to-delivery time and maternal satisfaction associated with vaginal misoprostol combined with a Foley balloon to those associated with vaginal misoprostol alone for labor induction.

Methods: This was a prospective cohort study involving singleton full-term pregnant women with fetuses who were observed in the cephalic position; these patients were divided into a combination group (25 µg vaginal misoprostol combined with a Foley balloon, n = 94) and a misoprostol group (25 µg vaginal misoprostol, n = 105). The primary outcome was the induction-to-delivery time, and the secondary outcomes included maternal satisfaction, mode of delivery and neonatal conditions.

Results: The induction-to-delivery time was significantly lower in the combination group than in the misoprostol group (13.91 [10.85-21.48] hours vs. 17.8 [12.63-26.63] hours, respectively; P = 0.016), and this difference was still observed in analyses including only those women with vaginal births (13.40 [10.65-20.47] hours vs. 18.49 [12.91-27.00] hours, respectively; P = 0.001). Stratified analysis revealed that this benefit was particularly significant among nulliparous women. The questionnaire survey revealed similar levels of maternal satisfaction with birth experience between the combination group and the misoprostol group (69.9% vs. 66.7%, P = 0.627) but a higher rate of pain during labor induction in the combination group (16% vs. 5.8%, P = 0.02). No significant differences were observed in neonatal conditions, satisfaction rates regarding the duration of labor induction and the frequency and intensity of contractions between the groups.

Conclusion: Vaginal misoprostol combined with a Foley balloon effectively shortens the induction-to-delivery time but induces more severe pain during labor induction, thus providing overall satisfaction comparable to that of vaginal misoprostol for labor induction. An optimal scheme for labor induction should be determined according to expectations regarding the induction-to-delivery time, and the personal feelings of the pregnant women.

Keywords: Clinical comparison; Foley; Induction of labor; Misoprostol; Satisfaction.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: This study received approval from the Ethics Committee of the Fourth Hospital of Hebei Medical University (Approval Number: 2020KY420). All of the methods were performed in accordance with approved protocols and relevant guidelines and regulations. All of the participants provided signed informed consent for participating in the study. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests.

Figures

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CONSORT flow diagram
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