Trial · NCT00828711
Misoprostol Vaginal Insert (MVI) 100, 150, 200 mcg for Cervical Ripening and Induction of Labor
NCT00828711, Phase 2, Completed, Ferring Pharmaceuticals; results first posted 2014-04-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Misoprostol Vaginal Insert (MVI) 100, 150, 200 mcg for Cervical Ripening and Induction of Labor. Trials, record NCT00828711. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00828711
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Misoprostol Vaginal Insert (MVI) 100, 150, 200 mcg for Cervical Ripening and Induction of Labor
- NCT number
- NCT00828711
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 374 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Cervical Ripening, Induction of Labor
- Interventions
- MVI 100, MVI 150, MVI 200
- First posted
- 2009-01-26
- Last updated
- 2014-04-21
- Results first posted
- 2014-04-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Women Delivering Vaginally | Interval from study drug administration to 24 hours | |
| Secondary | Time to Vaginal Delivery | Interval from study drug administration to delivery (average 24 hours) | |
| Secondary | Rate of Adverse Events | From study drug administration to hospital discharge (approximately 48 - 72 hours) | All adverse events were rated by the Investigator as mild, moderate or severe and classified as having no relationship, possible relationship or a probable relationship to the study drug. These assessments were deemed as accurate and appropriate for the reporting of all serious and non serious adverse events. |
| Secondary | Proportion of Cesarean Delivery | Interval from study drug administration to cesarean delivery (average 24 hours) | |
| Secondary | Cervical Ripening Using Composite Measure of Success | 12 hours after insertion of drug | Cervical ripening success was defined by achievement of one or more of the following by 12 hours after study drug administration: * Increase from baseline in modified Bishop score ≥3; or * Achievement of modified Bishop score of ≥6; or * Vaginal delivery. |
| Secondary | Use of Oxytocin | At least 30 minutes after study drug removal | Percentage of participants in receipt of Oxytocin for induction after study drug removal is accurate and appropriate for this outcome measure. |
| Secondary | Time of Maximum Plasma Concentration (Tmax), Maximum Plasma Concentration (Cmax), Area Under the Curve (AUC) and Terminal Half Life of Misoprostol Acid. | From study drug insertion up to 2 hours post study drug removal | The timepoints over which the pharmacokinetic measurements were assessed, and deemed as accurate and appropriate, were as follows: 0 hours (baseline), 2, 4, 6, 8, 10 and 14 hours after insertion of the study drug, immediately prior to removal of the study drug and 0.5, 1 and 2 hours after removal of the study drug. |
| Secondary | Time to Onset of Active Labor | Interval from study drug administration to active labor (average 12 hours) |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Women Delivering Vaginally | Interval from study drug administration to 24 hours | Analysis based on Modified Intention-to-Treat (MITT) population who delivered vaginally. Percentage of subjects who delivered vaginally is presented. | percentage of participants | NUMBER |
| SECONDARY | Time to Vaginal Delivery | Interval from study drug administration to delivery (average 24 hours) | Kaplan-Meier Estimates are based on Modified Intention-to-Treat (MITT) population.Subjects who had a cesarean, discharged prior to delivery or withdrew consent during first hospitalization were censored (MVI 100: 37, MVI 150: 39, MVI 200: 31) using the longest time interval from study drug administration to cesarean or to Labor \& Delivery discharge | minutes | MEDIAN |
| SECONDARY | Rate of Adverse Events | From study drug administration to hospital discharge (approximately 48 - 72 hours) | The percentage of subjects with adverse events are presented for the Intrapartum (before delivery), postpartum (maternal) and neonatal periods. | percentage of participants | NUMBER |
| SECONDARY | Proportion of Cesarean Delivery | Interval from study drug administration to cesarean delivery (average 24 hours) | Percentage of subjects who had a cesarean delivery during the first hospitalization (safety population) is presented. | percentage of participants | NUMBER |
| SECONDARY | Cervical Ripening Using Composite Measure of Success | 12 hours after insertion of drug | Percentage of subjects with cervical ripening success at 12 hours is presented (Modified Intention-to-Treat population). | percentage of participants | NUMBER |
| SECONDARY | Use of Oxytocin | At least 30 minutes after study drug removal | Percentage of subjects who required pre-delivery oxytocin is presented (Modified Intention-to-Treat population). | percentage of participants | NUMBER |
| SECONDARY | Time of Maximum Plasma Concentration (Tmax), Maximum Plasma Concentration (Cmax), Area Under the Curve (AUC) and Terminal Half Life of Misoprostol Acid. | From study drug insertion up to 2 hours post study drug removal | The plan was to enrol 24 subjects to the pharmacokinetic (PK) arm of the study. Only 3 subjects enrolled in the PK arm; there were too few subjects and too few samples available. Due to insufficient data, no statistical analysis was possible. Only misoprostol acid levels for each blood sampling timepoint for each subject was determined. | PK Parameters | NUMBER |
| SECONDARY | Time to Onset of Active Labor | Interval from study drug administration to active labor (average 12 hours) | Kaplan-Meier Estimates for Time to Onset of Active Labor presented (Modified Intention-to-Treat population). Subjects who never went into active labor during the first hospitalization were censored using the longest time interval from study drug administration to delivery (Censored subjects = MVI 100: 5; MVI 150: 7; MVI 200: 8) | minutes | MEDIAN |
Source ClinicalTrials.gov
Results by group29
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Women Delivering Vaginally | MVI 100 | 63.75 | 95% Confidence Interval 52.24 to 74.21 | percentage of participants | |
| Proportion of Women Delivering Vaginally | MVI 150 | 66.67 | 95% Confidence Interval 55.75 to 76.42 | percentage of participants | |
| Proportion of Women Delivering Vaginally | MVI 200 | 76.00 | 95% Confidence Interval 66.43 to 83.98 | percentage of participants | |
| Time to Vaginal Delivery | MVI 100 | 1744 | 95% Confidence Interval 1368 to 2198 | minutes | |
| Time to Vaginal Delivery | MVI 150 | 1535 | 95% Confidence Interval 1292 to 2063 | minutes | |
| Time to Vaginal Delivery | MVI 200 | 1181 | 95% Confidence Interval 1035 to 1443 | minutes | |
| Rate of Adverse Events | MVI 100 | Subjects with Intrapartum Adverse Events | 81.4 | percentage of participants | |
| Rate of Adverse Events | MVI 150 | Subjects with Intrapartum Adverse Events | 80.0 | percentage of participants | |
| Rate of Adverse Events | MVI 200 | Subjects with Intrapartum Adverse Events | 79.4 | percentage of participants | |
| Rate of Adverse Events | MVI 100 | Subjects with Maternal Postpartum Adverse Events | 28.0 | percentage of participants |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MVI 100 | 118 | |
| Overall Study | STARTED | MVI 150 | 125 | |
| Overall Study | STARTED | MVI 200 | 131 | |
| Overall Study | COMPLETED | MVI 100 | 117 | |
| Overall Study | COMPLETED | MVI 150 | 125 | |
| Overall Study | COMPLETED | MVI 200 | 131 | |
| Overall Study | NOT COMPLETED | MVI 100 | 1 | |
| Overall Study | NOT COMPLETED | MVI 150 | 0 | |
| Overall Study | NOT COMPLETED | MVI 200 | 0 |
Source ClinicalTrials.gov
Adverse events168
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 | Anaemia # | Blood and lymphatic system disorders | MVI 100 | 10 | 118 | 10 |
| other | Anaemia # | Blood and lymphatic system disorders | MVI 150 | 8 | 125 | 8 |
| other | Anaemia # | Blood and lymphatic system disorders | MVI 200 | 11 | 131 | 11 |
| other | Abnormal labour affecting foetus + | Pregnancy, puerperium and perinatal conditions | MVI 100 | 8 | 118 | 8 |
| other | Abnormal labour affecting foetus + | Pregnancy, puerperium and perinatal conditions | MVI 150 | 12 | 125 | 14 |
| other | Abnormal labour affecting foetus + | Pregnancy, puerperium and perinatal conditions | MVI 200 | 16 | 131 | 16 |
| other | Caput succedaneum * | Pregnancy, puerperium and perinatal conditions | MVI 100 | 4 | 118 | 4 |
| other | Caput succedaneum * | Pregnancy, puerperium and perinatal conditions | MVI 150 | 5 | 125 | 5 |
| other | Caput succedaneum * | Pregnancy, puerperium and perinatal conditions | MVI 200 | 7 | 131 | 7 |
| other | Chorioamnionitis + | Pregnancy, puerperium and perinatal conditions | MVI 100 | 5 | 118 | 5 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MVI 100 | ||
| Total, all-cause mortality | MVI 150 | ||
| Total, all-cause mortality | MVI 200 | ||
| Total, other adverse events | MVI 100 | 100 | 118 |
| Total, other adverse events | MVI 150 | 107 | 125 |
| Total, other adverse events | MVI 200 | 117 | 131 |
| Total, serious adverse events | MVI 100 | 43 | 118 |
| Total, serious adverse events | MVI 150 | 48 | 125 |
| Total, serious adverse events | MVI 200 | 42 | 131 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21343755 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00828711
GET https://conductscience.org/api/trials/v1/NCT00828711/results?page=2