Dilapan-S® for Induction of Labor The Feasibility Study

NCT ID: NCT04521062

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2022-12-31

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.

Conditions

Induction of Labor Affected Fetus / Newborn

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Dilapan S

Placement of dilators

Group Type: OTHER

Dilapan S

Intervention Type: DEVICE

Placement of Dilapan S

Interventions

Dilapan S

Placement of Dilapan S

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Albany Medical College

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tara Lynch, MD

Role: PRINCIPAL_INVESTIGATOR

Albany Medical College

Locations

Albany Medical Center

Albany, New York, United States

Countries

United States

Other Identifiers

5768

Identifier Type: -

Identifier Source: org_study_id