Effectiveness and safety of amniotomy after cervical ripening by Foley's catheter balloon on induction of mid-trimester fetal death in utero: a randomized clinical trial
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Abstract
Objective: To explore the value and safety of amniotomy after cervical ripening by Foley catheter balloon on termination of mid-trimester fetal death in utero.
Materials and methods: The study was a randomized clinical trial conducted at Assiut Woman's Health Hospital, Egypt, from November 2021 to June 2023 on non-scared uterus women with mid-trimester fetal death in utero (18–26 weeks). Participants were subjected to Foley catheter balloon insertion and then assigned to group I: Amniotomy group or group II: No amniotomy group according to the randomization. The main outcome was the mean interval (hours) between Foley catheter balloon expulsion to complete abortion. The outcome variables were analyzed using an Independent sample t-test, Mann–Whitney U, and Chi-square test.
Results: Sixty women were included in the study. The balloon expulsion to abortion time was shorter in the amniotomy group than the no-amniotomy group with a statistically significant difference (6.89 ± 2.02 hours vs. 9.22 ± 1.98 hours; p < 0.001). The mean dose of oxytocin was higher in the no-amniotomy group than in the amniotomy group with a statistically significant difference (76.61 ±15.78 IU vs. 57.55 ±16.88 IU; p < 0.001). No statistically significant differences were found between groups as regards the rate of complications.
Conclusion: Performing amniotomy after using a Foley catheter balloon for cervical ripening during induction of mid-trimester fetal death in utero in a non-scarred uterus reduces the time to abortion as well as the oxytocin dose and the procedure is relatively safe.
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