Phase 4
Completed N=307
Comparison of Misoprostol Ripening Efficacy With Dilapan
Labor Onset and Length Abnormalities · Induced; Birth
Source: ClinicalTrials.gov NCT03670836 ↗
Enrolled (actual)
307
Serious AEs
1.3%
Results posted
Jul 2024
Primary outcomePrimary: Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in ITT Population — 93; 90 Participants
◆ Published Evidence
Highly cited
139citations · ~46 / year
Mechanical methods for induction of labour.
Summary
The purpose of this study is to find out if Dilapan works as well as Misoprostol for preparing the mouth of the uterus (cervix) for inducing labor in women who need to undergo this procedure. The primary objective is to assess the efficacy of Dilapan for cervical ripening compared to Misoprostol in women undergoing Induction of labor (IOL) at or more than 37 weeks gestation.
Linked Publications (2)
-
Mechanical methods for induction of labour.
-
Cervical Ripening Efficacy of Synthetic Osmotic Cervical Dilator Compared With Oral Misoprostol at Term: A Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in ITT Population |
93; 90 | — |
| PRIMARY Number of Women Achieving Vaginal Delivery Within 36 Hours After Initiation of Cervical Ripening in PP Population |
86; 86 | — |
| SECONDARY Change in Bishop Score |
2; 3 | — |
| SECONDARY Percentage of Women Delivering Vaginally in 24 Hours After the Initiation of Intervention |
62; 58 | — |
| SECONDARY Overall Vaginal Delivery Rate |
104; 104 | — |
| SECONDARY Number of Participants With Cesarean Deliveries |
41; 42 | — |
| SECONDARY Total Length of Hospital Stay |
80.5; 84.0 | — |
| SECONDARY Percentage of Women Who Developed Chorioamnionitis |
12; 10 | — |
| SECONDARY Percentage of Women Who Developed Postpartum Hemorrhage |
1; 3 | — |
| SECONDARY Percentage of Newborns With Apgar Score <7 at 5 Min |
0; 1 | — |
| SECONDARY Percentage of Newborns With Cord Arterial Blood Potential Hydrogen (pH) < 7.1 |
0; 4 | — |
| SECONDARY Percentage of Newborns With Neonatal Intensive Care Unit (NICU) Admission Within 14 Days After Study Intervention |
9; 8 | — |
| SECONDARY Percentage of Newborns With Antibiotic Use Within 14 Days After Study Intervention |
5; 4 | — |
Eligibility Criteria
Inclusion Criteria
- Women undergoing labor induction with a gestation of ≥37 weeks (based on a sure last menstrual period and an ultrasound done before 22 0/7 weeks)
- Live fetus with in cephalic presentation
- Singleton pregnancy
- Able to provide informed consent for participation in the study
Exclusion Criteria
- Contraindication for vaginal delivery
- Age less than 18 years
- Prior uterine scar from a cesarean section or myomectomy
- Patients who have HELLP syndrome or eclampsia
- Active genital herpes at the time of labor induction
- Complex medical problems that may require assistance with second stage of labor
- Bishop score ≥ 6
- Major fetal congenital anomalies (as assessed by investigator)
- Premature rupture of membranes
Data sourced from ClinicalTrials.gov (NCT03670836) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.