Bollapragada, S., MacKenzie, F., Norrie, J.D., Eddama, O., Petrou, S., Reid, M. and Norman, J.E. (2009) Randomised placebo-controlled trial of outpatient (at home) cervical ripening with isosorbide mononitrate (IMN) prior to induction of labour - clinical trial with analyses of efficacy and acceptability. The IMOP Study. BJOG: An International Journal of Obstetrics and Gynaecology, 116(9), pp. 1185-1195. (doi: 10.1111/j.1471-0528.2009.02216.x)
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Publisher's URL: http://dx.doi.org/10.1111/j.1471-0528.2009.02216.x
Abstract
Objective: To determine whether isosorbide mononitrate (IMN), self-administered vaginally by women at home, improves the process of induction of labour. Design: Randomised double blind placebo-controlled trial. Setting: Large UK maternity hospital. Population or Sample: Nulliparous women with a singleton pregnancy, cephalic presentation ≥37 weeks gestation, requiring cervical ripening prior to induction of labour. Methods: IMN (n = 177) or placebo (n = 173) self-administered vaginally at home at 48, 32 and 16 hours prior to the scheduled time of admission for induction. Main outcome measures: Admission to delivery interval and women’s experience of induction of labour. Results: IMN did not shorten the admission to delivery interval as compared with placebo [mean difference of −1.6 hours (95% CI −5.1,1.9, P = 0.37)], despite being more effective than placebo in inducing a change in Bishop score [mean difference of 0.65 (95% CI 0.14,1.17, P = 0.013)]. While both groups found the overall experience of home treatment to be positive, (mean score of 3.8/10 ± 2.3/10 for the IMN group, where 1 = extremely good and 10 = not at all good) women in the placebo group found it marginally more positive than those in the IMN group (just over half a unit on a 10-point scale, P = 0.043). There were no differences between the groups in the pain or anxiety experienced or willingness to take the treatment in a subsequent pregnancy. Conclusions: IMN self-administered vaginally at home does not shorten admission to delivery interval despite a significant effect on cervical ripeness assessed using the Bishop score. However, women report positive views on cervical ripening at home, and the setting deserves further investigation.
Item Type: | Articles |
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Status: | Published |
Refereed: | Yes |
Glasgow Author(s) Enlighten ID: | Reid, Professor Margaret and Norrie, Prof John and Norman, Professor Jane |
Authors: | Bollapragada, S., MacKenzie, F., Norrie, J.D., Eddama, O., Petrou, S., Reid, M., and Norman, J.E. |
College/School: | College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre ?? 20206000 ?? College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing |
Journal Name: | BJOG: An International Journal of Obstetrics and Gynaecology |
Publisher: | Wiley-Blackwell Publishing Ltd. |
ISSN: | 1470-0328 |
ISSN (Online): | 1471-0528 |
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