Trial · NCT03670836
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| 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 |
| Secondary | Percentage of Newborns With Cord Arterial Blood Potential Hydrogen (pH) < 7.1 | From birth until two weeks after birth | This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns |
| Secondary | Percentage of Newborns With Neonatal Intensive Care Unit (NICU) Admission Within 14 Days After Study Intervention | From birth until two weeks after birth | This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns |
| Secondary | Percentage of Newborns With Antibiotic Use Within 14 Days After Study Intervention | From birth until two weeks after birth | This is to measure the safety of either Dilapan or Misoprostol for cervical ripening by studying the effect on newborns |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03670836/registered