Phase 3
Completed N=300
Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE)
Source: ClinicalTrials.gov NCT02408315 ↗Enrolled (actual)
300
Serious AEs
6.7%
Results posted
Jul 2019
Primary outcomePrimary: Time to Delivery — 28.1; 20.1 hours — p=0.663
◆ Published Evidence
Established
35citations · ~5 / year
A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term (the IMPROVE trial): a triple-masked randomized controlled trial.
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.
Linked Publications (2)
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A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term (the IMPROVE trial): a triple-masked randomized controlled trial.
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Pharmacokinetics of vaginal versus buccal misoprostol for labor induction at term.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Delivery |
28.1; 20.1 | 0.663 |
| PRIMARY Number of Participants With Cesarean Deliveries Based on Fetal Non-Reassurance Indications |
14; 5 | — |
| SECONDARY Number of Vaginal Deliveries That Occurred Within 24 Hours |
58; 89 | — |
| SECONDARY Number of Participants Who Had Uterine Hyperstimulation |
18; 22 | — |
| SECONDARY Number of Neonatal Intensive Care Unit (NICU) Admission |
30; 31 | — |
| SECONDARY Number of Doses Misoprostol Used |
3; 2 | — |
| SECONDARY Uterine Rupture |
0; 0 | — |
| SECONDARY Dose of Oxytocin Used for Augmentation |
6; 4 | — |
| SECONDARY Number of Participants With Neonatal Cord Gases Measured |
12; 15 | — |
Eligibility Criteria
Inclusion Criteria
- A medical indication for induction of labor at a gestational age between 37 +0 and 38 +6 weeks OR an elective or medical indication for induction of labor at a gestational age greater than or equal to 39 + 0 completed weeks
- Participant age of greater than or equal to14 years old
- Singleton pregnancy
- Modified Bishop score of less than or equal to 6
- Vertex fetal presentation by examination or ultrasound
- Any membrane status
Exclusion Criteria
- Elective inductions between 37 +0 and 38 +6 completed weeks are specifically excluded
- Known intrauterine fetal demise
- Any uterine scar including prior cesarean section and myomectomy
- Known major fetal congenital malformations that may impact neonatal health
- Other evidence of fetal compromise (such as Category 2 or 3 tracing) before the induction begins
- Prior induction/cervical ripening methods utilized during this pregnancy
- Allergy to misoprostol
- Known untreated cervical infection (e.g. Gonorrhea, Chlamydia)
- Planned cesarean section due to maternal or fetal condition
- Any other contraindication to labor induction or misoprostol therapy
Data sourced from ClinicalTrials.gov (NCT02408315) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.