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Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE)

NCT02408315 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-04-13

Study results available
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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.

Conditions

  • Pregnancy

Interventions

DRUG

misoprostol/placebo

buccal or vaginal routes of administration/ placebo to compare methods for efficacy and safety during induction.

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • David M Haas, MD · IU School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-11-30
Completion
2021-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02408315 on ClinicalTrials.gov