Dilapan-S® for Induction of Labor The Feasibility Study

NCT04521062 | Terminated FDA Device

• 1 other identifier: 5768
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Induction of Labor Affected Fetus / Newborn

Keywords

cervical ripening; induction of labor

Outcome Measures

Primary Outcomes (1)

• Time to delivery

  Length of time between induction of labor start and delivery (hours)

  from induction start to delivery, estimated average 12 hours

Secondary Outcomes (6)

• APGAR score at 1and 5 min

  1 and 5 minutes after birth

• number of participants with maternal infection

  during hospital admission, average 4 days

• NICU admission

  through maternal hospital admission, average 4 days

• Need for neonatal antibiotics

  in the first 72 hours after delivery

• Need for resipiratory support

  during hospital admission, average 4 days

Study Arms (1)

Dilapan S

OTHER

Placement of dilators

Device: Dilapan S

Interventions

Dilapan S DEVICE

Placement of Dilapan S

Dilapan S

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned induction of labor ≥ 39 weeks
• Singleton gestation
• Vertex presentation
• Cervical dilation \<3cm

You may not qualify if:

• Placenta previa
• Placenta accreta
• Vasa previa
• Preterm prelabor rupture of membranes
• Non-english speaking
• \<18 years old
• Multiple gestation
• Prior cesarean delivery
• Prior myomectomy
• Fetal malpresentation
• Active vaginal bleeding
• Cervical dilation \>1 cm
• Uterine anomaly (didelphysis, bicornuate)
• Intrauterine growth restriction \<10th%
• Fetal anomalies

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (1)

Albany Medical Center

Albany, New York, 12208, United States

Location

Study Officials

• Tara Lynch, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: August 20, 2020
• Study Start: August 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)