N/A
N=338
Comparing Outpatient to Inpatient Cervical Ripening Using Dilapan-S®
Labor, Induced · Cervix Uteri-Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03665688 ↗Enrolled (actual)
338
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Number of Participants With Hospital Stay Longer Than 48 Hours — 89; 152 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Outpatient Dilapan-S (Device); Inpatient Dilapan-S (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Medical Branch, Galveston
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Hospital Stay Longer Than 48 Hours |
89; 152 | — |
| SECONDARY Number of Participants With Vaginal Deliveries 2-4 Days |
125; 128 | — |
| SECONDARY Number of Participants With Vaginal Deliveries - 24 Hours |
117; 86 | — |
| SECONDARY Time From Hospital Admission to Active Stage of Labor |
545; 1183 | — |
| SECONDARY Change in Bishop Score From Insertion of Device to Extraction |
2; 2 | — |
| SECONDARY Number of Participants With Operative Vaginal Delivery |
6; 5 | — |
| SECONDARY Number of Participants With Cesarean Delivery |
42; 43 | — |
Summary
The target population for our study is women who present for induction of labor. If there is a decision by the obstetrical team to place a mechanical dilator for cervical ripening, the obstetrical team will notify the research staff so that the patient may be screened for the study. If the subject is eligible for the trial, written informed consent will be obtained by person-to-person contact. The PI, study coordinator, or a collaborator will be responsible for the informed consent procedure. After informed consent is obtained and Dilapan-S is placed, the patient will be randomized to the Outpatient or the Inpatient group.
Eligibility Criteria
Inclusion Criteria
- Pregnant woman whose plan of care is induction of labor
- Maternal age between 18 and 45 years
- Understanding and capable to sign informed consent
- Singleton pregnancy
- Gestational age ≥ 37 0/7 weeks (based on a sure last menstrual period or a first trimester dating ultrasound)
- Live fetus in cephalic presentation
- Intact membranes
- Pelvic exam (sterile vaginal exam) of less than or equal to 3cm and at most 60% effaced
Exclusion Criteria
- Active labor
- Active genital herpes
- Chorioamnionitis
- Transfundal uterine or cervical surgery
- Previous cesarean delivery
- Non-reassuring fetal status
- Need for continuous maternal or fetal monitoring during ripening
- Contraindication for vaginal delivery
- Active vaginal bleeding
- Abnormal placental location or adherence (placenta previa or unresolved low lying placenta)
- Estimated fetal weight > 5000 g (non diabetic) or > 4500 g (diabetic)
- Intrauterine growth restriction (estimated fetal weight <10 percentile)
- Oligohydramnios (amniotic fluid index < 5cm or deep vertical pocket of < 2 cm)
- Fetal anomaly
- Need for inpatient care (e.g. hypertension, insulin-dependent diabetes)
- Poor or no access to a telephone and cannot be placed in the hotel
- Absence of support person ( no adult accompanying the subject during outpatient cervical ripening period)
Data sourced from ClinicalTrials.gov (NCT03665688). 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.