Dilapan-S® for Induction of Labor The Feasibility Study

Not Applicable

Terminated

• Conditions: Induction of Labor Affected Fetus / Newborn
• Interventions: Device: Dilapan S

• Registration Number: NCT04521062
• Lead Sponsor: Albany Medical College

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-07-07
• Study Start: 2020-08-01
• Study First Submitted QC: 2020-08-19
• Study First Posted: 2020-08-20
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-14
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dilapan S	Dilapan S	Placement of dilators

Primary Outcome Measures

Name	Time	Method
Time to delivery	from induction start to delivery, estimated average 12 hours	Length of time between induction of labor start and delivery (hours)

Secondary Outcome Measures

Name	Time	Method
APGAR score at 1and 5 min	1 and 5 minutes after birth	APGAR score (number 0-10)
NICU admission	through maternal hospital admission, average 4 days	Neonatal admission to NICU (any admission) - Yes/No
Need for neonatal antibiotics	in the first 72 hours after delivery	any antibiotic use in postnatal period (yes/no)
Need for resipiratory support	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	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)
number of participants with maternal infection	during hospital admission, average 4 days	chorioamnionitis, endometritis - Yes/No

Trial Locations

Locations (1)

Albany Medical Center; 🇺🇸 Albany, New York, United States