Dilapan-S® for Induction of Labor The Feasibility Study

Overview

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

Full Title of Study: “Dilapan-S® for Induction of Labor – Assessing ouTpatient Placement and Effectiveness – The Feasibility Study (The DILATE Study).”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2022

Detailed Description

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.

Interventions

  • Device: Dilapan S
    • Placement of Dilapan S

Arms, Groups and Cohorts

  • Other: Dilapan S
    • Placement of dilators

Clinical Trial Outcome Measures

Primary Measures

  • Time to delivery
    • Time Frame: from induction start to delivery, estimated average 12 hours
    • Length of time between induction of labor start and delivery (hours)

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

1. Planned induction of labor ≥ 39 weeks 2. Singleton gestation 3. Vertex presentation 4. Cervical dilation <3cm Exclusion Criteria:

1. Placenta previa 2. Placenta accreta 3. Vasa previa 4. Preterm prelabor rupture of membranes 5. Non-english speaking 6. <18 years old 7. Multiple gestation 8. Prior cesarean delivery 9. Prior myomectomy 10. Fetal malpresentation 11. Active vaginal bleeding 12. Cervical dilation >1 cm 13. Uterine anomaly (didelphysis, bicornuate) 14. Intrauterine growth restriction <10th% 15. Fetal anomalies 16. Requirements to be inpatient 17. Polyhydramnios (AFI>25cm or MVP>8cm) 18. Chronic hypertension on medications 19. Gestational hypertension/preeclampsia 20. GDMA2, DM1, DM2 21. Hepatitis B or C 22. HIV

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Albany Medical College
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Tara Lynch, MD, Principal Investigator, Albany Medical College

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