Trial · NCT03670836
Comparison of Misoprostol Ripening Efficacy With Dilapan
NCT03670836, Phase 4, Completed, Columbia University; results first posted 2024-07-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of Misoprostol Ripening Efficacy With Dilapan. Trials, record NCT03670836. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03670836
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Misoprostol Ripening Efficacy With Dilapan
- NCT number
- NCT03670836
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 307 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Labor Onset and Length Abnormalities, Induced; Birth
- Interventions
- Dilapan, Misoprostol
- First posted
- 2018-09-14
- Last updated
- 2024-07-19
- Results first posted
- 2024-07-19
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in ITT Population | Up to 36 hours after intervention | This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening. Intent-to-treat Population (ITT) includes all patients that were randomized into the study. ITT participants will be analyzed in accordance with their randomized study treatment (i.e. in the treatment group they were originally allocated, regardless of treatment actually received). ITT will be used for evaluation of the baseline characteristics and as the primary population for efficacy assessments. |
| Primary | Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in PP Population | Up to 36 hours after intervention | This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening. |
| Secondary | Change in Bishop Score | Baseline and 12 hours after intervention | The Bishop Score (also known as Pelvic Score) is the most commonly used method to rate the readiness of the cervix for induction of labor. The Bishop Score gives points to 5 measurements of the pelvic examination dilation, effacement of the cervix, station of the fetus, consistency of the cervix, and position of the cervix. It ranges from 0 to 13. Higher score is associated with increased likelihood of vaginal delivery. |
| Secondary | Percentage of Women Delivering Vaginally in 24 Hours After the Initiation of Intervention | Up to 24 hours after intervention | This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening |
| Secondary | Overall Vaginal Delivery Rate | Approximately up to 48 hours | This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening |
| Secondary | Number of Participants With Cesarean Deliveries | Start of cervical ripening to delivery, up to 36 hours | This is to measure the efficacy of either Dilapan or Misoprostol for cervical ripening |
| Secondary | Total Length of Hospital Stay | Up to 4 days | This is to measure the cost-effectiveness of either Dilapan or Misoprostol for cervical ripening. Length will be measured in number of days from hospital admission until discharge. |
| Secondary | Percentage of Women Who Developed Chorioamnionitis | From delivery until two weeks after discharge (approximately up to 3 weeks) | This is to measure the safety of either Dilapan or Misoprostol for cervical ripening |
| Secondary | Percentage of Women Who Developed Postpartum Hemorrhage | From delivery until two weeks after discharge (approximately up to 3 weeks) | This is to measure the safety of either Dilapan or Misoprostol for cervical ripening, postpartum hemorrhage is defined as estimated blood loss (EBL) \> 1000cc and/or drop in Hematocrit (HCT) by 10 points. |
| Secondary | Percentage of Newborns With Apgar Score <7 at 5 Min | 5 minutes following birth | This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in ITT Population | Up to 36 hours after intervention | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in PP Population | Up to 36 hours after intervention | The Per Protocol (PP) population is a subset of ITT population. PP population is comprised of participants who completed the treatment originally allocated with complete adherence to the protocol. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Bishop Score | Baseline and 12 hours after intervention | Intent to treat population | score on a scale | MEDIAN |
| SECONDARY | Percentage of Women Delivering Vaginally in 24 Hours After the Initiation of Intervention | Up to 24 hours after intervention | Intent to treat population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Vaginal Delivery Rate | Approximately up to 48 hours | Intent to treat population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Cesarean Deliveries | Start of cervical ripening to delivery, up to 36 hours | ITT population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Total Length of Hospital Stay | Up to 4 days | Intent to treat population | hours | MEAN |
| SECONDARY | Percentage of Women Who Developed Chorioamnionitis | From delivery until two weeks after discharge (approximately up to 3 weeks) | Intent to treat population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Women Who Developed Postpartum Hemorrhage | From delivery until two weeks after discharge (approximately up to 3 weeks) | Intent to treat population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Newborns With Apgar Score <7 at 5 Min | 5 minutes following birth | Intent to treat population | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group26
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in ITT Population | Dilapan Group | 93 | Participants | ||
| Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in ITT Population | Misoprostol Group | 90 | Participants | ||
| Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in PP Population | Dilapan Group | 86 | Participants | ||
| Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in PP Population | Misoprostol Group | 86 | Participants | ||
| Change in Bishop Score | Dilapan Group | 2 | Full Range 0 to 11 | score on a scale | |
| Change in Bishop Score | Misoprostol Group | 3 | Full Range 0 to 11 | score on a scale | |
| Percentage of Women Delivering Vaginally in 24 Hours After the Initiation of Intervention | Dilapan Group | 62 | Participants | ||
| Percentage of Women Delivering Vaginally in 24 Hours After the Initiation of Intervention | Misoprostol Group | 58 | Participants | ||
| Overall Vaginal Delivery Rate | Dilapan Group | 104 | Participants | ||
| Overall Vaginal Delivery Rate | Misoprostol Group | 104 | Participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Intent-to-treat Population (ITT) | STARTED | Misoprostol Group- 153 | 153 | |
| Intent-to-treat Population (ITT) | STARTED | Dilapan Group 154 | 154 | |
| Intent-to-treat Population (ITT) | COMPLETED | Misoprostol Group- 153 | 152 | |
| Intent-to-treat Population (ITT) | COMPLETED | Dilapan Group 154 | 151 | |
| Intent-to-treat Population (ITT) | NOT COMPLETED | Misoprostol Group- 153 | 1 | |
| Intent-to-treat Population (ITT) | NOT COMPLETED | Dilapan Group 154 | 3 | |
| Per Protocol Population (PP) | STARTED | Misoprostol Group- 153 | 152 | |
| Per Protocol Population (PP) | STARTED | Dilapan Group 154 | 151 | |
| Per Protocol Population (PP) | COMPLETED | Misoprostol Group- 153 | 138 | |
| Per Protocol Population (PP) | COMPLETED | Dilapan Group 154 | 134 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse 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 | uterine tachysystole | Pregnancy, puerperium and perinatal conditions | Dilapan Group | 35 | 151 | 35 |
| other | uterine tachysystole | Pregnancy, puerperium and perinatal conditions | Misoprostol Group | 70 | 152 | 70 |
| other | uterine tachy systole with abnormal fetal heart tracing | Pregnancy, puerperium and perinatal conditions | Dilapan Group | 4 | 151 | 4 |
| other | uterine tachy systole with abnormal fetal heart tracing | Pregnancy, puerperium and perinatal conditions | Misoprostol Group | 11 | 152 | 11 |
| serious | postpartum hemorrhage | Pregnancy, puerperium and perinatal conditions | Dilapan Group | 1 | 151 | 1 |
| serious | postpartum hemorrhage | Pregnancy, puerperium and perinatal conditions | Misoprostol Group | 3 | 152 | 3 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dilapan Group | 0 | 151 |
| Total, all-cause mortality | Misoprostol Group | 0 | 152 |
| Total, other adverse events | Dilapan Group | 39 | 151 |
| Total, other adverse events | Misoprostol Group | 81 | 152 |
| Total, serious adverse events | Dilapan Group | 1 | 151 |
| Total, serious adverse events | Misoprostol Group | 3 | 152 |
Source ClinicalTrials.gov
Papers2
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 comparisons13
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dilapan Group vs Misoprostol Group: Percentage of Women Who Developed Chorioamnionitis | Trial comparisons |
| Dilapan Group vs Misoprostol Group: Percentage of Women Who Developed Postpartum Hemorrhage | Trial comparisons |
| Dilapan Group vs Misoprostol Group: Number of Participants With Cesarean Deliveries | Trial comparisons |
| Dilapan Group vs Misoprostol Group: Percentage of Women Delivering Vaginally in 24 Hours After the Initiation of Intervention | Trial comparisons |
| Dilapan Group vs Misoprostol Group: Percentage of Newborns With Neonatal Intensive Care Unit (NICU) Admission Within 14 Days After Study Intervention | Trial comparisons |
| Dilapan Group vs Misoprostol Group: Percentage of Newborns With Antibiotic Use Within 14 Days After Study Intervention | Trial comparisons |
| Dilapan Group vs Misoprostol Group: Percentage of Newborns With Cord Arterial Blood Potential Hydrogen (pH) < 7.1 | Trial comparisons |
| Dilapan Group vs Misoprostol Group: Overall Vaginal Delivery Rate | Trial comparisons |
| Dilapan Group vs Misoprostol Group: Percentage of Newborns With Apgar Score <7 at 5 Min | Trial comparisons |
| Dilapan Group vs Misoprostol Group: Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in ITT Population | Trial comparisons |
1 to 10 of 13
See all 13 trial comparisonsTests0
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/NCT03670836
GET https://conductscience.org/api/trials/v1/NCT03670836/results?page=2