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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
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Bollapragada, S. S., MacKenzie, F. M., Norrie, J. D., Eddama, O., Petrou, Stavros, Reid, M. and Norman, Jane 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 & Gynaecology, Vol.116 (No.9). pp. 1185-1195. ISSN 14700328
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Official 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: | Journal Article |
|---|---|
| Subjects: | R Medicine > RA Public aspects of medicine R Medicine > RG Gynecology and obstetrics R Medicine > RM Therapeutics. Pharmacology |
| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School |
| Library of Congress Subject Headings (LCSH): | Labor, Induced (Obstetrics), Self medication, Self-care, Health, Clinical trials, Placebos (Medicine) |
| Journal or Publication Title: | BJOG: An International Journal of Obstetrics & Gynaecology |
| Publisher: | Wiley-Blackwell Publishing Ltd. |
| ISSN: | 14700328 |
| Date: | 2009 |
| Volume: | Vol.116 |
| Number: | No.9 |
| Page Range: | pp. 1185-1195 |
| Identification Number: | 10.1111/j.1471-0528.2009.02216.x |
| Status: | Peer Reviewed |
| Publication Status: | Published |
| Access rights to Published version: | Restricted or Subscription Access |
| Funder: | WellBeing (Organization) |
| URI: | http://wrap.warwick.ac.uk/id/eprint/37018 |
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