Efficacy and safety of oral hyoscine used for outpatient cervical ripening among primiparous women with term pregnancy.

OBJECTIVE: To assess the efficacy and safety of outpatient administration of oral hyoscine for cervical ripening. METHODS: In a randomized controlled trial at a university hospital in Tehran between September 2017 and December 2018, 100 primiparous women with singleton pregnancy at 380 -400 gestational weeks and Bishop score of 5 or less were randomized to either routine expectant management (control group) or 10 mg of oral hyoscine twice daily for 1 week, followed by once daily for 1 week (hyoscine group). RESULTS: Mean ± SD Bishop score in the hyoscine and control groups was, respectively, 1.19 ± 1.38 and 1.08 ± 1.70 at baseline, and 4.56 ± 2.87 and 2.76 ± 2.14 on admission for delivery (P=0.001). Duration of the first stage was 4.10 ± 5.49 hours in the hyoscine and 5.29 ± 6.48 hours in the control group (P=0.03). Duration of the second and third stages was, respectively, 0.52 ± 0.53 and 0.14 ± 0.25 hours in the hyoscine, and 0.59 ± 1.08 and 0.12 ± 0.15 hours in the control group. No adverse effects were reported. CONCLUSION: Administration of oral hyoscine in an outpatient setting was found to ripen the cervix with no clinically significant adverse drug reaction. IRANIAN REGISTRY OF CLINICAL TRIALS (IRCT20180819040830N1).