Trial · NCT00308711
Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor
NCT00308711, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2010-02-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor. Trials, record NCT00308711. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00308711
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor
- NCT number
- NCT00308711
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,308 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Cervical Ripening, Labor, Induced
- Interventions
- Misoprostol vaginal insert 100 mcg, Misoprostol vaginal insert 50 mcg, Dinoprostone vaginal insert (Cervidil)
- First posted
- 2006-03-30
- Last updated
- 2012-06-25
- Results first posted
- 2010-02-19
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Minutes From Drug Insertion to Vaginal Delivery | 2880 minutes | Interval between time/date of insertion of study drug and time/date of neonate birth. This is a time-to-event analysis, there is no set time for the assessment. The endpoint occurs when the baby is born. 48 hours can be used as an approximate interval by which time most of the babies have been delivered. |
| Primary | Percentage of Participants With a Cesarean Section Delivery | 2880 minutes | Percentage of participants with cesarean delivery after study drug was administered. There is no set assessment time or date as the woman's labor may last hours or days. |
| Secondary | Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events | 96 hours | This outcome reports the percentage of adverse events in each treatment arm spontaneously reported or observed during the study. The intrapartum period (mother is still pregnant) is called the "Maternal/Fetal" period; once the baby has been born, adverse events are assessed separately for the mother (Post Partum) and the baby (Neonatal). The number of adverse events was assessed separately for each of the three periods. |
| Secondary | Percentage of Participants With Pre-Delivery Oxytocin Use | 2880 minutes | Incidence in each treatment group of need for oxytocin for pre-delivery induction or augmentation of labor. |
| Secondary | Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert | 12 hours | Measured the percentage of participants who achieved success on the mBS. This composite score is based on the mBS and vaginal delivery and it is measured 12 hours after insertion of the study drug. The mBS has a score of 0 when the cervix is not ripe and a score of 12 when completely ripened. The 12 hour score is compared to baseline. Using the mBS, assess at 12 hours whether each subject has met any of the following three criteria: 1) has improved (increased) the mBS by at least 3 points from baseline; 2) has reached a score of at least 6 on the mBS; or 3) has acheived a vaginal delivery. |
| Secondary | Minutes to Onset of Active Labor | 2880 minutes | Interval from insertion of study drug to onset of active labor, defined as at least three contractions in a ten-minute period of at least moderate intensity and resulting in cervical change such as dilatation or effacement; OR at least 4 cm cervical dilatation achieved after progressive change in dilatation. |
| Secondary | Minutes to Rupture of Membranes (ROM) | 2880 minutes | Interval from study drug insertion to ROM. |
| Secondary | Duration of Stay in Minutes in Labor and Delivery Suite | 5760 minuts | Minutes in Labor and Delivery (L \& D) suite starting from insertion of the study drug to discharge from L \& D to post partum care. |
| Secondary | Days in Hospital for Mother and Neonate | 10 days | Duration of stay in hospital for mother and neonate starting with insertion of the study drug and ending with discharge from the hospital. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Minutes From Drug Insertion to Vaginal Delivery | 2880 minutes | This analysis is for time to vaginal delivery (interval from insertion of study drug into the vagina to the delivery of the neonate); patients delivered by cesarean section were censored from this time-to-event analysis using the longest interval for all participants from insertion of study drug to cesarean section delivery of neonate. | minutes | MEDIAN |
| PRIMARY | Percentage of Participants With a Cesarean Section Delivery | 2880 minutes | Percentage of participants | NUMBER | |
| SECONDARY | Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events | 96 hours | Analysis was based on intention to treat, i.e., all subjects who had the insert placed in the vagina. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Pre-Delivery Oxytocin Use | 2880 minutes | This analysis included all participants exposed to study drug and for whom there was data available regarding whether oxytocin was used pre-delivery. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Cervical Ripening Success Based On Modified Bishop Score (mBS) 12 Hours After Administration of Vaginal Insert | 12 hours | Percentage of Participants | NUMBER | |
| SECONDARY | Minutes to Onset of Active Labor | 2880 minutes | minutes | MEAN | |
| SECONDARY | Minutes to Rupture of Membranes (ROM) | 2880 minutes | minutes | MEDIAN | |
| SECONDARY | Duration of Stay in Minutes in Labor and Delivery Suite | 5760 minuts | minutes | MEAN | |
| SECONDARY | Days in Hospital for Mother and Neonate | 10 days | days | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Minutes From Drug Insertion to Vaginal Delivery | Misoprostol Vaginal Insert (MVI) 100 | 1595.5 | 95% Confidence Interval 1469 to 1739 | minutes | |
| Minutes From Drug Insertion to Vaginal Delivery | Misoprostol Vaginal Insert (MVI) 50 | 2127 | 95% Confidence Interval 1977 to 2253 | minutes | |
| Minutes From Drug Insertion to Vaginal Delivery | Cervidil 10 mg Vaginal Insert | 1649.5 | 95% Confidence Interval 1509 to 1824 | minutes | |
| Percentage of Participants With a Cesarean Section Delivery | Misoprostol Vaginal Insert (MVI) 100 | 28 | 23.6 to 32.3 | Percentage of participants | |
| Percentage of Participants With a Cesarean Section Delivery | Misoprostol Vaginal Insert (MVI) 50 | 28 | 23.9 to 32.4 | Percentage of participants | |
| Percentage of Participants With a Cesarean Section Delivery | Cervidil 10 mg Vaginal Insert | 26 | 22.3 to 30.8 | Percentage of participants | |
| Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events | Misoprostol Vaginal Insert (MVI) 100 | Maternal/Fetal | 65 | Percentage of participants | |
| Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events | Misoprostol Vaginal Insert (MVI) 50 | Maternal/Fetal | 64 | Percentage of participants | |
| Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events | Cervidil 10 mg Vaginal Insert | Maternal/Fetal | 65 | Percentage of participants | |
| Percentage of Participants With Maternal/Fetal, Maternal (Post-Partum), and Neonatal Adverse Events | Misoprostol Vaginal Insert (MVI) 100 | Maternal (Post-Partum) | 29 | Percentage of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Misoprostol Vaginal Insert (MVI) 100 | 428 | |
| Overall Study | STARTED | Misoprostol Vaginal Insert (MVI) 50 | 444 | |
| Overall Study | STARTED | Cervidil 10 mg Vaginal Insert | 436 | |
| Overall Study | COMPLETED | Misoprostol Vaginal Insert (MVI) 100 | 426 | |
| Overall Study | COMPLETED | Misoprostol Vaginal Insert (MVI) 50 | 440 | |
| Overall Study | COMPLETED | Cervidil 10 mg Vaginal Insert | 431 | |
| Overall Study | NOT COMPLETED | Misoprostol Vaginal Insert (MVI) 100 | 2 | |
| Overall Study | NOT COMPLETED | Misoprostol Vaginal Insert (MVI) 50 | 4 | |
| Overall Study | NOT COMPLETED | Cervidil 10 mg Vaginal Insert | 5 |
Source ClinicalTrials.gov
Adverse events201
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 | Abnormal labour affecting foetus | Pregnancy, puerperium and perinatal conditions | Misoprostol Vaginal Insert (MVI) 100 | 24 | 428 | 24 |
| other | Abnormal labour affecting foetus | Pregnancy, puerperium and perinatal conditions | Misoprostol Vaginal Insert (MVI) 50 | 12 | 443 | 12 |
| other | Abnormal labour affecting foetus | Pregnancy, puerperium and perinatal conditions | Cervidil 10 mg Vaginal Insert | 28 | 436 | 28 |
| other | Chorioamnionitis | Pregnancy, puerperium and perinatal conditions | Misoprostol Vaginal Insert (MVI) 100 | 17 | 428 | 17 |
| other | Chorioamnionitis | Pregnancy, puerperium and perinatal conditions | Misoprostol Vaginal Insert (MVI) 50 | 30 | 443 | 30 |
| other | Chorioamnionitis | Pregnancy, puerperium and perinatal conditions | Cervidil 10 mg Vaginal Insert | 22 | 436 | 22 |
| other | Foetal heart rate disorder | Pregnancy, puerperium and perinatal conditions | Misoprostol Vaginal Insert (MVI) 100 | 130 | 428 | 130 |
| other | Foetal heart rate disorder | Pregnancy, puerperium and perinatal conditions | Misoprostol Vaginal Insert (MVI) 50 | 129 | 443 | 129 |
| other | Foetal heart rate disorder | Pregnancy, puerperium and perinatal conditions | Cervidil 10 mg Vaginal Insert | 132 | 436 | 132 |
| other | Meconium in amniotic fluid | Pregnancy, puerperium and perinatal conditions | Misoprostol Vaginal Insert (MVI) 100 | 38 | 428 | 38 |
1 to 10 of 201Source ClinicalTrials.gov
See all 201 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Misoprostol Vaginal Insert (MVI) 100 | ||
| Total, all-cause mortality | Misoprostol Vaginal Insert (MVI) 50 | ||
| Total, all-cause mortality | Cervidil 10 mg Vaginal Insert | ||
| Total, other adverse events | Misoprostol Vaginal Insert (MVI) 100 | 130 | 428 |
| Total, other adverse events | Misoprostol Vaginal Insert (MVI) 50 | 129 | 443 |
| Total, other adverse events | Cervidil 10 mg Vaginal Insert | 132 | 436 |
| Total, serious adverse events | Misoprostol Vaginal Insert (MVI) 100 | 106 | 428 |
| Total, serious adverse events | Misoprostol Vaginal Insert (MVI) 50 | 134 | 443 |
| Total, serious adverse events | Cervidil 10 mg Vaginal Insert | 117 | 436 |
Source ClinicalTrials.gov
Papers7
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 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.
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