Phase 3 N=300 Randomized Triple-blind Diagnostic

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

Pregnancy

Bottom Line

View on ClinicalTrials.gov: NCT02408315 ↗

Enrolled (actual)

300

Serious AEs

6.7%

Results posted

Jul 2019

Primary outcome: Primary: Time to Delivery — 28.1; 20.1 hours — p=0.663

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: misoprostol/placebo (Drug)
Age: Pediatric, Adult · 14+ yrs
Sex: Female
Sponsor: Indiana University
Primary completion: Nov 2017

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02408315). 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.