drugset / Trial / NCT03171480
Use of Nitrous Oxide Donor for Labor Induction in Women With PreEclampsia
RandomizedParallel-groupQuadruple-blindPrevention
Summary
A randomized controlled trial (RCT) of nitric-oxide donor (NOD) isosorbide mononitrate (IMN) versus placebo as an adjuvant to misoprostol/ intra-cervical Foley bulb for induction of labor to decrease rate of cesarean deliveries in pregnancies complicated by preeclampsia (≥24/0 weeks' gestation)
Timeline
- Start
- 2017-10-30
- Primary completion
- 2020-07-01
- Completion
- 2020-07-01
Publications
- Background Buhimschi I, Ali M, Jain V, Chwalisz K, Garfield RE. Differential regulation of nitric oxide in the rat uterus and cervix during pregnancy and labour. Hum Reprod. 1996 Aug;11(8):1755-66. doi: 10.1093/oxfordjournals.humrep.a019481.
- Background Ghosh A, Lattey KR, Kelly AJ. Nitric oxide donors for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2016 Dec 5;12(12):CD006901. doi: 10.1002/14651858.CD006901.pub3.
- Background Chanrachakul B, Herabutya Y, Punyavachira P. Randomized trial of isosorbide mononitrate versus misoprostol for cervical ripening at term. Int J Gynaecol Obstet. 2002 Aug;78(2):139-45. doi: 10.1016/s0020-7292(02)00128-5.
- Background El-Khayat W, Alelaiw H, El-kateb A, Elsemary A. Comparing vaginal misoprostol versus Foley catheter plus vaginal isosorbide mononitrate for labor induction. J Matern Fetal Neonatal Med. 2016;29(3):487-92. doi: 10.3109/14767058.2015.1007036. Epub 2015 Feb 19.
- Background Thomson AJ, Lunan CB, Cameron AD, Cameron IT, Greer IA, Norman JE. Nitric oxide donors induce ripening of the human uterine cervix: a randomised controlled trial. Br J Obstet Gynaecol. 1997 Sep;104(9):1054-7. doi: 10.1111/j.1471-0528.1997.tb12066.x.
- Results Collingham JP, Fuh KC, Caughey AB, Pullen KM, Lyell DJ, El-Sayed YY. Oral misoprostol and vaginal isosorbide mononitrate for labor induction: a randomized controlled trial. Obstet Gynecol. 2010 Jul;116(1):121-126. doi: 10.1097/AOG.0b013e3181e408f2.
- Gee SE, Ma'ayeh M, Cackovic H, Samuels P, Thung SF, Landon MB, Rood KM. Addition of vaginal isosorbide mononitrate for labor induction in pregnancies complicated by hypertensive diseases of pregnancy: a randomized controlled trial. Am J Obstet Gynecol MFM. 2021 Jul;3(4):100343. doi: 10.1016/j.ajogmf.2021.100343. Epub 2021 Feb 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Isosorbide Mononitrate | Other / unclassified | 40 mg | Other |