Dilapan-S® for Induction of Labor The Feasibility Study

Study Overview
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Brief Summary
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This is a prospective feasibility study to investigate Dilapan-S® as an outpatient method of cervical ripening in low risk pregnancies >=39 weeks.

Detailed Description
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In 2019, the ARRIVE trial was published, demonstrating that in low risk nulliparous women, induction of labor at 39 weeks was associated with a decreased risk for hypertensive disorders of pregnancy and decreased risk for cesarean without any increased risk for severe neonatal complications or perinatal death. (1) Based on the results of this trial, hospitals have been questioning the feasibility of implementing a protocol which offers induction of labor to low risk women at ≥39 weeks. There are concerns regarding the ability of a busy labor and delivery to accommodate women presenting for inductions with an unfavorable cervix. Outpatient mechanical cervical ripening would allow for women to start the process of induction of labor at home. This is appealing because cervical ripening is typically the longest component of the induction process. Mechanical cervical ripening is the process by which balloons or dilators are placed into the cervix. There is lack of evidence on Dilapan-S® as an outpatient method of cervical ripening despite the potential benefits of increased maternal satisfaction and decreased length of hospital stay. With this in mind we propose a preliminary study of 40 women to assess for feasibility of performing a large randomized control trial and assess safety with outpatient treatment. This initial study is intended to assess the feasibility of outpatient cervical ripening, next day induction of labor, and safety. After completion of this feasibility study, the investigators plan to initiate a randomized control trial to assess the efficacy of outpatient Dilapan-S® for mechanical cervical ripening.

Official Title
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Dilapan-S® for Induction of Labor - Assessing ouTpatient Placement and Effectiveness - The Feasibility Study (The DILATE Study).

Conditions
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Induction of Labor Affected Fetus / Newborn

Intervention / Treatment
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* Device: Dilapan S


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned induction of labor ≥ 39 weeks Singleton gestation Vertex presentation Cervical dilation <3cm Exclusion Criteria: Placenta previa Placenta accreta Vasa previa Preterm prelabor rupture of membranes Non-english speaking <18 years old Multiple gestation Prior cesarean delivery Prior myomectomy Fetal malpresentation Active vaginal bleeding Cervical dilation >1 cm Uterine anomaly (didelphysis, bicornuate) Intrauterine growth restriction <10th% Fetal anomalies Requirements to be inpatient Polyhydramnios (AFI>25cm or MVP>8cm) Chronic hypertension on medications Gestational hypertension/preeclampsia GDMA2, DM1, DM2 Hepatitis B or C HIV
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dilapan S<br>Placement of dilators | Device: Dilapan S<br>* Placement of Dilapan S<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to delivery | Length of time between induction of labor start and delivery (hours) | from induction start to delivery, estimated average 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| APGAR score at 1and 5 min | APGAR score (number 0-10) | 1 and 5 minutes after birth | 
| number of participants with maternal infection | chorioamnionitis, endometritis - Yes/No | during hospital admission, average 4 days | 
| NICU admission | Neonatal admission to NICU (any admission) - Yes/No | through maternal hospital admission, average 4 days | 
| Need for neonatal antibiotics | any antibiotic use in postnatal period (yes/no) | in the first 72 hours after delivery | 
| Need for resipiratory support | any respiratory interventions after birth for neonate (composite of oxygen administration, respiratory distress syndrome, CPAP, intubation) (yes/No) | during hospital admission, average 4 days | 
| mode of delivery | cesarean or vaginal (coded as cesarean delivery Y/N or vaginal delivery Y/N) | one time at the time of delivery, variable to occur during hospital admission, average 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervical ripening, induction of labor