NCT04521062

Dilapan-S® for Induction of Labor The Feasibility Study

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Albany Medical College · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Induction of Labor Affected Fetus / Newborn

Interventions

Type	Name	Description
DEVICE	Dilapan S	Placement of Dilapan S

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2020-08-20
• Last updated: 2023-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study