At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium
In Brief
A Phase 3 clinical trial evaluating misoprostol/placebo for Pregnancy. Completed, enrolled 300 participants across 2 sites.
Detailed Summary
The primary objective of this study is to compare the efficacy and safety of vaginal and buccal misoprostol for women undergoing labor induction at greater than or equal to 37+ 0 completed weeks gestation. Thus, the investigators have both efficacy and a safety primary outcomes. The secondary objective of this study is to assess the pharmacokinetic(PK) parameters with these two routes of administration in a sub-cohort of this trial. The long term objective of this line of research is to inform providers' clinical decision making for the large number of women having labor induction. By providing robust PK and pharmacodynamic (PD) evaluation, clinical outcomes data for these two routes of administration, clinicians will be informed for evidence-based decisions about the preferred route of administration of misoprostol.
Study Details
Timeline
Interventions
buccal or vaginal routes of administration/ placebo to compare methods for efficacy and safety during induction.