Titrated oral compared with vaginal misoprostol for labor induction: a randomized controlled trial.
OBJECTIVE
To compare the efficacy and safety of titrated oral misoprostol and vaginal misoprostol for labor induction.


METHODS
Women between 34 and 42 weeks of gestation with an unfavorable cervix (Bishop score less than or equal to 6) and an indication for labor induction were randomLy assigned to receive titrated oral or vaginal misoprostol. The titrated oral misoprostol group received a basal unit of 20 mL misoprostol solution (1 mcg/mL) every 1 hour for four doses and then were titrated against individual uterine response. The vaginal group received 25 mcg every 4 hours until attaining a more favorable cervix. Vaginal delivery within 12 hours was the primary outcome. The data were analyzed by intention-to-treat.


RESULTS
Titrated oral misoprostol was given to 101 (48.8%) women and vaginal misoprostol to 106 (51.2%) women. Completed vaginal delivery occurred within 12 hours in 75 (74.3%) women in the titrated oral group and 27 (25.5%) women in the vaginal group (relative risk [RR] 8.44, 95% confidence interval [CI] 4.52-15.76). The incidence of hyperstimulation was 0.0% in the titrated oral group compared with 11.3% in the vaginal group (RR 0.08, 95% CI 0.01-0.61). Although more women experienced nausea (10.9%) in the titrated oral group (RR 27.07, 95% CI 1.57-465.70), fewer infants had Apgar scores of less than 7 at 1 minute in the titrated oral group than in the vaginal group (RR 0.10, 95% CI 0.01-0.76).


CONCLUSIONS
Titrated oral misoprostol is associated with a lower incidence of uterine hyperstimulation and a lower cesarean delivery rate than vaginal misoprostol for labor induction in patients with unfavorable cervix.


BACKGROUND
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00529295


METHODS
I.
Cheng
Shi-Yann
SY
Department of Obstetrics, China Medical University Beigang, Hospital, Beigang, Yunlin, China. shiyann@ms18.url.com.tw
Ming
Ho
H
Lee
Jui-Chi
JC
D000282:Administration, Intravaginal; D000284:Administration, Oral; D000328:Adult; D020070:Cervical Ripening / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007751:Labor, Induced / Q000009:adverse effects / Q000379:methods*; D016595:Misoprostol / Q000008:administration & dosage* / Q000009:adverse effects; D010120:Oxytocics / Q000008:administration & dosage* / Q000009:adverse effects; D011247:Pregnancy
D010120:Oxytocics; D016595:Misoprostol