Trial · NCT02408315
Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE)
NCT02408315, Phase 3, Completed, Indiana University; results first posted 2019-07-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE). Trials, record NCT02408315. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02408315
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Induction With Misoprostol: Oral Mucosa Versus Vaginal Epithelium (IMPROVE)
- NCT number
- NCT02408315
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 300 participants, actual
- Lead sponsor
- Indiana University
- Conditions
- Pregnancy
- Interventions
- misoprostol/placebo
- First posted
- 2015-04-03
- Last updated
- 2022-04-13
- Results first posted
- 2019-07-09
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Delivery | from study entry until delivery- anticipated 3 days | number of hours from placement of study drug to delivery Cesarean delivery for fetal non--reassurance indication |
| Primary | Number of Participants With Cesarean Deliveries Based on Fetal Non-Reassurance Indications | from study entry until delivery- anticipated 3 days | Rate of cesarean deliveries performed for fetal non-reassurance as the indication |
| Secondary | Number of Vaginal Deliveries That Occurred Within 24 Hours | from study entry until delivery- anticipated 3 days | rate of achieving vaginal delivery within 24 hours |
| Secondary | Number of Participants Who Had Uterine Hyperstimulation | from study entry until delivery- anticipated 3 days | Presence of uterine hyperstimulation, tachysystole as defined as 6 uterine contractions in a 10 minute period |
| Secondary | Number of Neonatal Intensive Care Unit (NICU) Admission | from study entry until discharge of newborn- anticipated up to 28 days | Admission to NICU |
| Secondary | Number of Doses Misoprostol Used | from study entry until delivery- anticipated 3 days | Number of doses of misoprostol needed |
| Secondary | Uterine Rupture | from study entry until delivery- anticipated 3 days | Presence of uterine rupture |
| Secondary | Dose of Oxytocin Used for Augmentation | from study entry until delivery- anticipated 3 days | dose of oxytocin used for augmentation of labor |
| Secondary | Number of Participants With Neonatal Cord Gases Measured | from study entry until delivery- anticipated 3 days | cord gases from newborn |
| Other | Pharmacokinetic Profiling of Misoprostol | from study entry until delivery- anticipated 3 days | pharmacokinetic parameters (Area under the curve, half-life, maximum concentration) measured over first 2 study drug doses |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Delivery | from study entry until delivery- anticipated 3 days | hours | MEDIAN | |
| PRIMARY | Number of Participants With Cesarean Deliveries Based on Fetal Non-Reassurance Indications | from study entry until delivery- anticipated 3 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Vaginal Deliveries That Occurred Within 24 Hours | from study entry until delivery- anticipated 3 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Had Uterine Hyperstimulation | from study entry until delivery- anticipated 3 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Neonatal Intensive Care Unit (NICU) Admission | from study entry until discharge of newborn- anticipated up to 28 days | participants | NUMBER | |
| SECONDARY | Number of Doses Misoprostol Used | from study entry until delivery- anticipated 3 days | doses | MEDIAN | |
| SECONDARY | Uterine Rupture | from study entry until delivery- anticipated 3 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Dose of Oxytocin Used for Augmentation | from study entry until delivery- anticipated 3 days | milliunits per minute | MEDIAN | |
| SECONDARY | Number of Participants With Neonatal Cord Gases Measured | from study entry until delivery- anticipated 3 days | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Pharmacokinetic Profiling of Misoprostol | from study entry until delivery- anticipated 3 days |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Delivery | Buccal Misoprostol/Vaginal Placebo | 28.1 | 95% Confidence Interval 24.1 to 31.4 | hours | |
| Time to Delivery | Vaginal Misoprostol/Buccal Placebo | 20.1 | 95% Confidence Interval 18.2 to 22.8 | hours | |
| Number of Participants With Cesarean Deliveries Based on Fetal Non-Reassurance Indications | Buccal Misoprostol/Vaginal Placebo | 14 | Participants | ||
| Number of Participants With Cesarean Deliveries Based on Fetal Non-Reassurance Indications | Vaginal Misoprostol/Buccal Placebo | 5 | Participants | ||
| Number of Vaginal Deliveries That Occurred Within 24 Hours | Buccal Misoprostol/Vaginal Placebo | 58 | Participants | ||
| Number of Vaginal Deliveries That Occurred Within 24 Hours | Vaginal Misoprostol/Buccal Placebo | 89 | Participants | ||
| Number of Participants Who Had Uterine Hyperstimulation | Buccal Misoprostol/Vaginal Placebo | 18 | Participants | ||
| Number of Participants Who Had Uterine Hyperstimulation | Vaginal Misoprostol/Buccal Placebo | 22 | Participants | ||
| Number of Neonatal Intensive Care Unit (NICU) Admission | Buccal Misoprostol/Vaginal Placebo | 30 | participants | ||
| Number of Neonatal Intensive Care Unit (NICU) Admission | Vaginal Misoprostol/Buccal Placebo | 31 | participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Buccal Misoprostol/Vaginal Placebo | 148 | |
| Overall Study | STARTED | Vaginal Misoprostol/Buccal Placebo | 152 | |
| Overall Study | COMPLETED | Buccal Misoprostol/Vaginal Placebo | 148 | |
| Overall Study | COMPLETED | Vaginal Misoprostol/Buccal Placebo | 152 | |
| Overall Study | NOT COMPLETED | Buccal Misoprostol/Vaginal Placebo | 0 | |
| Overall Study | NOT COMPLETED | Vaginal Misoprostol/Buccal Placebo | 0 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Any Maternal or Fetal Event | Pregnancy, puerperium and perinatal conditions | Buccal Misoprostol/Vaginal Placebo | 68 | 148 | 68 |
| other | Any Maternal or Fetal Event | Pregnancy, puerperium and perinatal conditions | Vaginal Misoprostol/Buccal Placebo | 71 | 152 | 71 |
| serious | Inpatient or Postpartum Hospitalization | General disorders | Buccal Misoprostol/Vaginal Placebo | 11 | 148 | 11 |
| serious | Inpatient or Postpartum Hospitalization | General disorders | Vaginal Misoprostol/Buccal Placebo | 8 | 152 | 11 |
| serious | Other Life Threatening Event | Pregnancy, puerperium and perinatal conditions | Buccal Misoprostol/Vaginal Placebo | 0 | 148 | |
| serious | Other Life Threatening Event | Pregnancy, puerperium and perinatal conditions | Vaginal Misoprostol/Buccal Placebo | 1 | 152 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Buccal Misoprostol/Vaginal Placebo | 0 | 148 |
| Total, all-cause mortality | Vaginal Misoprostol/Buccal Placebo | 0 | 152 |
| Total, other adverse events | Buccal Misoprostol/Vaginal Placebo | 68 | 148 |
| Total, other adverse events | Vaginal Misoprostol/Buccal Placebo | 71 | 152 |
| Total, serious adverse events | Buccal Misoprostol/Vaginal Placebo | 11 | 148 |
| Total, serious adverse events | Vaginal Misoprostol/Buccal Placebo | 9 | 152 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Buccal Misoprostol/Vaginal Placebo vs Vaginal Misoprostol/Buccal Placebo: Number of Participants Who Had Uterine Hyperstimulation | Trial comparisons |
| Buccal Misoprostol/Vaginal Placebo vs Vaginal Misoprostol/Buccal Placebo: Uterine Rupture | Trial comparisons |
| Buccal Misoprostol/Vaginal Placebo vs Vaginal Misoprostol/Buccal Placebo: Number of Vaginal Deliveries That Occurred Within 24 Hours | Trial comparisons |
| Buccal Misoprostol/Vaginal Placebo vs Vaginal Misoprostol/Buccal Placebo: Number of Neonatal Intensive Care Unit (NICU) Admission | Trial comparisons |
| Buccal Misoprostol/Vaginal Placebo vs Vaginal Misoprostol/Buccal Placebo: Number of Participants With Cesarean Deliveries Based on Fetal Non-Reassurance Indications | Trial comparisons |
| Buccal Misoprostol/Vaginal Placebo vs Vaginal Misoprostol/Buccal Placebo: Number of Participants With Neonatal Cord Gases Measured | Trial comparisons |
| Buccal Misoprostol/Vaginal Placebo vs Vaginal Misoprostol/Buccal Placebo: deaths from any cause | Trial comparisons |
| Buccal Misoprostol/Vaginal Placebo vs Vaginal Misoprostol/Buccal Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02408315
GET https://conductscience.org/api/trials/v1/NCT02408315/registered