Dilapan-S® for Induction of Labor The Feasibility Study

Induction of Labor Affected Fetus / Newborn Clinical Trial

— DILATE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04521062
• Other study ID #: 5768
• Status: Terminated
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Albany Medical College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Induction of Labor Affected Fetus / Newborn

Intervention

Device:
• Dilapan S
Placement of Dilapan S

Locations

Country	Name	City	State
United States	Albany Medical Center	Albany	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to delivery	Length of time between induction of labor start and delivery (hours)	from induction start to delivery, estimated average 12 hours
Secondary	APGAR score at 1and 5 min	APGAR score (number 0-10)	1 and 5 minutes after birth
Secondary	number of participants with maternal infection	chorioamnionitis, endometritis - Yes/No	during hospital admission, average 4 days
Secondary	NICU admission	Neonatal admission to NICU (any admission) - Yes/No	through maternal hospital admission, average 4 days
Secondary	Need for neonatal antibiotics	any antibiotic use in postnatal period (yes/no)	in the first 72 hours after delivery
Secondary	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
Secondary	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