Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE) (NCT02408315) | Clinical Trial Compass
CompletedPhase 3
Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE)
United States300 participantsStarted 2015-09
Plain-language 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.
Who can participate
Age range
14 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to Delivery
Timeframe: from study entry until delivery- anticipated 3 days
2
Number of Participants With Cesarean Deliveries Based on Fetal Non-Reassurance Indications
Timeframe: from study entry until delivery- anticipated 3 days