Randomized Placebo-Controlled Trial of Outpatient (at Home) Cervical Ripening With Isosorbide Mononitrate (IMN) Prior to Induction of Labor-Clinical Trial With Analyses of Efficacy and Acceptability: The IMOP Study EDITORIAL COMMENT

S. S. Bollapragada*, F. MacKenzie, J. D. Norrie, O. Eddama, S. Petrou, M. Reid, J. E. Norman

*Corresponding author for this work

Research output: Contribution to journalEditorialpeer-review

Abstract

Several investigators have hypothesized that outpatient preinduction cervical ripening with nitric oxide donors such as isosorbide mononitrate (IMN) would reduce the elapsed time from hospital admission to delivery and improve women's experience of induction of labor. This double-blind randomized placebo-controlled trial investigated whether vaginal self-administration at home by woman at term would improve the process of induction of labor. The study subjects were 350 nulliparous singleton women with cephalic presentation at ≥37 weeks' gestation, requiring cervical ripening before induction of labor. The participants self-administered IMN (n = 177) or placebo (n = 173) vaginally at home without fetal monitoring at 48, 32, and 16 hours before the scheduled time of admission for induction of labor. The primary study outcome measures were the elapsed time interval from hospital admission to delivery and the women's experience of home treatment for cervical ripening. Maternal satisfaction was determined with a questionnaire, using a 10 point scale with 1 = extremely good and 10 = not at all good.

There was no statistically significant difference between the 2 study groups in the admission to delivery interval; the mean difference was 1.59 hours, with a 95% confidence interval (CI) of −5.08 to 1.89, P = 0.37. Compared to placebo, however, IMN was more effective in inducing a mean change in modified Bishop score from recruitment to hospital admission (mean difference: 0.65 [95% CI, 0.14–1.17, P = 0.013]). With regard to maternal satisfaction, the overall experience of home treatment was positive in both groups. Women in the placebo group reported it to be marginally more positive than those in the IMN group (placebo: 3.23 vs. IMN: 3.84; the mean difference was 0.61, with a 95% CI of 0.02–1.21, P = 0.043). No difference between the 2 groups was reported in either pain or anxiety levels or in the willingness to have the treatment in a subsequent pregnancy.

These data show that administration of IMN at home is effective in ripening the cervix but does not shorten the admission to delivery interval or improve maternal satisfaction. The investigators conclude from these findings that IMN in this setting has limited clinical value.
Original languageEnglish
Pages (from-to)699-700
Number of pages2
JournalObstetrical & Gynecological Survey
Volume64
Issue number11
DOIs
Publication statusPublished - Nov 2009

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