Dilapan-S® for Induction of Labor The Feasibility Study (DILATE)

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

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

Study Overview

• Status: Terminated
• Conditions: Induction of Labor Affected Fetus / Newborn
• Intervention / Treatment: Device: Dilapan S

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tara Lynch, MD; Phone Number: 518-264-3217; Email: lyncht2@amc.edu

Study Locations

• United States
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Dilapan S; Placement of dilators	Device: Dilapan S; Placement of Dilapan S

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Albany Medical College

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: July 7, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: cervical ripening; induction of labor
• Other Study ID Numbers: 5768

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No