drugset / Trial / NCT03489928

Misoprostol Labour Induction Study

NCT03489928

Phase 3 Completed 511 enrolled David Young
RandomizedParallel-groupOpen-labelTreatment

Summary

Labour induction is a frequent obstetric intervention (\~20%). Prostaglandins (PGs) are effective agents, but gastrointestinal (GI) intolerance has limited use to non-oral routes. The traditional oxytocin "drip" requires intravenous (IV) use and discourages mobility. Misoprostol, a PG analogue, is marketed for oral treatment of GI disorders, but initiates uterine contraction, an undesirable GI side effect. Recently, there has been a research "boom" on vaginal misoprostol use in pregnancy to induce term labour drawing on this "side effect:". The principal investigator has led one of three groups worldwide which has published on oral misoprostol to study effectiveness, GI tolerance, and safety for mother/baby in term labour induction. Cost per patient has been less then one percent that of other PGs, even less than IV oxytocin.

Timeline

Start
1999-04-01
Primary completion
2000-12-01
Completion
2000-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dinoprostone Other / unclassified 1 mg Intravenous
Subject Dinoprostone Other / unclassified 2 mg Intravenous
Subject Misoprostol Other / unclassified 25 ug Oral
Subject Misoprostol Other / unclassified 50 ug Oral

Indications

No indication recorded.