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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Treatments: Misoprostol

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