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NCT02408315 · ClinicalTrials.gov registry record · Phase 3
Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE)
A Phase 3 study of Pregnancy, sponsored by Indiana University.
- Completed
- Registry status
- Phase 3
- Development phase
- 300
- Enrollment target
- 2
- Study locations
NCT02408315: Completed Phase 3 study of Pregnancy, sponsored by Indiana University.
NCT02408315 is a Phase 3 study of Pregnancy that has completed, run by Indiana University. The registered enrollment target is 300 participants, below the 871-participant average among 191 other Pregnancy trials with a reported enrollment target (66% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02408315, a Phase 3 study of Pregnancy, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 300 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
number of hours from placement of study drug to delivery Cesarean delivery for fetal non--reassurance indication
Conditions Studied
Interventions
- DRUG misoprostol/placebo
Study Locations (2)
Indiana
- IU Health Methodist Hospital - Indianapolis
- Sidney and Lois Eskenazi Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2015-09 |
| Est. Completion | 2021-12 |
| Phase | Phase 3 |
What the finished NCT02408315 record still lists
NCT02408315 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 871-participant average among 191 other Pregnancy trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Pregnancy appearing as the primary indexed condition, and to 1 intervention - of which misoprostol/placebo is the first listed.
NCT02408315 reports a single indexed study location in Indiana.
Frequently Asked Questions
What is clinical trial NCT02408315 about?
NCT02408315 is a clinical study titled "Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE)". 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 objec...
What is the current status of trial NCT02408315?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 300 participants. The study started on 2015-09. Estimated completion is 2021-12.
What conditions does trial NCT02408315 study?
This clinical trial studies the following conditions: Pregnancy.
What interventions are being tested in trial NCT02408315?
The interventions under investigation include: misoprostol/placebo (DRUG).
Who is sponsoring clinical trial NCT02408315?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02408315 being conducted?
This trial has 2 study locations across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02408315's enrollment target sits among peer trials
300 68th of 191 higher than 120 of 191 other Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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