Isosorbide mononitrate for preinduction cervical ripening at or post-term pregnancy: randomised placebo-controlled clinical trial
Introduction Effective labour induction is marked by the onset of uterine contractions, progressive cervical dilation, and effacement, culminating in a vaginal birth without maternal or fetal complications. The success of induction largely depends on cervical ripening. Isosorbide mononitrate (ISMN),...
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BMJ Publishing Group
2025-01-01
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| Series: | Gynecology and Obstetrics Clinical Medicine |
| Online Access: | https://gocm.bmj.com/content/5/1/e000064.full |
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| author | Ramy Mohamed El-Naggar Ahmed Nagy Shaker Mohamed Attia Raslan Heba Rady El-Bassyouny |
| author_facet | Ramy Mohamed El-Naggar Ahmed Nagy Shaker Mohamed Attia Raslan Heba Rady El-Bassyouny |
| author_sort | Ramy Mohamed El-Naggar |
| collection | DOAJ |
| description | Introduction Effective labour induction is marked by the onset of uterine contractions, progressive cervical dilation, and effacement, culminating in a vaginal birth without maternal or fetal complications. The success of induction largely depends on cervical ripening. Isosorbide mononitrate (ISMN), a nitric oxide donor, has shown potential for cervical ripening, facilitating labour induction by promoting cervical softening, effacement and dilation. This study evaluates the efficacy and safety of ISMN for cervical ripening before labour induction at term or post-term.Methods In this double-blinded randomised controlled trial, 160 primigravidas with an unripe cervix (Bishop score<6) undergoing labour induction at term or post-term were enrolled. The ISMN group received 40 mg of intravaginal ISMN in the posterior fornix every 4 hours, up to four doses. The placebo group received intravaginal pyridoxine placebos on the same schedule. The primary outcome measured was the duration from labour induction to placental delivery. Secondary outcomes included caesarean section rates.Results The ISMN group had a statistically significant shorter induction-to-delivery time compared with the placebo group (20.57±4.64 hours vs 23.15±5.13 hours, p=0.01). Additionally, the time from the first dose to delivery was reduced in the ISMN group. The caesarean section rate was lower in the ISMN group (29% vs 41%, p=0.17), though this difference was not statistically significant.Conclusion ISMN is an effective and safe option for cervical ripening, potentially shortening the labour duration.Trial registration number https://clinicaltrials.gov/study/NCT03544606. |
| format | Article |
| id | doaj-art-aa5e500346c44ee1addffc653d521c61 |
| institution | Kabale University |
| issn | 2097-0587 2667-1646 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | Gynecology and Obstetrics Clinical Medicine |
| spelling | doaj-art-aa5e500346c44ee1addffc653d521c612025-01-22T03:00:14ZengBMJ Publishing GroupGynecology and Obstetrics Clinical Medicine2097-05872667-16462025-01-015110.1136/gocm-2024-000064Isosorbide mononitrate for preinduction cervical ripening at or post-term pregnancy: randomised placebo-controlled clinical trialRamy Mohamed El-Naggar0Ahmed Nagy Shaker1Mohamed Attia Raslan2Heba Rady El-Bassyouny3Obstetric and Gynecology, Tanta University, Tanta, Gharbia, EgyptObstetrics and Gynecology, Kafr el-Sheikh University, Kafr el-Sheikh, EgyptObstetric and Gynecology, Tanta University, Tanta, Gharbia, EgyptObstetric and Gynecology, Tanta University, Tanta, Gharbia, EgyptIntroduction Effective labour induction is marked by the onset of uterine contractions, progressive cervical dilation, and effacement, culminating in a vaginal birth without maternal or fetal complications. The success of induction largely depends on cervical ripening. Isosorbide mononitrate (ISMN), a nitric oxide donor, has shown potential for cervical ripening, facilitating labour induction by promoting cervical softening, effacement and dilation. This study evaluates the efficacy and safety of ISMN for cervical ripening before labour induction at term or post-term.Methods In this double-blinded randomised controlled trial, 160 primigravidas with an unripe cervix (Bishop score<6) undergoing labour induction at term or post-term were enrolled. The ISMN group received 40 mg of intravaginal ISMN in the posterior fornix every 4 hours, up to four doses. The placebo group received intravaginal pyridoxine placebos on the same schedule. The primary outcome measured was the duration from labour induction to placental delivery. Secondary outcomes included caesarean section rates.Results The ISMN group had a statistically significant shorter induction-to-delivery time compared with the placebo group (20.57±4.64 hours vs 23.15±5.13 hours, p=0.01). Additionally, the time from the first dose to delivery was reduced in the ISMN group. The caesarean section rate was lower in the ISMN group (29% vs 41%, p=0.17), though this difference was not statistically significant.Conclusion ISMN is an effective and safe option for cervical ripening, potentially shortening the labour duration.Trial registration number https://clinicaltrials.gov/study/NCT03544606.https://gocm.bmj.com/content/5/1/e000064.full |
| spellingShingle | Ramy Mohamed El-Naggar Ahmed Nagy Shaker Mohamed Attia Raslan Heba Rady El-Bassyouny Isosorbide mononitrate for preinduction cervical ripening at or post-term pregnancy: randomised placebo-controlled clinical trial Gynecology and Obstetrics Clinical Medicine |
| title | Isosorbide mononitrate for preinduction cervical ripening at or post-term pregnancy: randomised placebo-controlled clinical trial |
| title_full | Isosorbide mononitrate for preinduction cervical ripening at or post-term pregnancy: randomised placebo-controlled clinical trial |
| title_fullStr | Isosorbide mononitrate for preinduction cervical ripening at or post-term pregnancy: randomised placebo-controlled clinical trial |
| title_full_unstemmed | Isosorbide mononitrate for preinduction cervical ripening at or post-term pregnancy: randomised placebo-controlled clinical trial |
| title_short | Isosorbide mononitrate for preinduction cervical ripening at or post-term pregnancy: randomised placebo-controlled clinical trial |
| title_sort | isosorbide mononitrate for preinduction cervical ripening at or post term pregnancy randomised placebo controlled clinical trial |
| url | https://gocm.bmj.com/content/5/1/e000064.full |
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