Dilapan-S® for Induction of Labor The Feasibility Study (DILATE)

A

Albany Medical College

Status

Terminated

Conditions

Induction of Labor Affected Fetus / Newborn

Treatments

Device: Dilapan S

Study type

Interventional

Funder types

Other

Identifiers

NCT04521062
5768

Details and patient eligibility

About

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

Full 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.

Enrollment

22 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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
  • Requirements to be inpatient
  • Polyhydramnios (AFI>25cm or MVP>8cm)
  • Chronic hypertension on medications
  • Gestational hypertension/preeclampsia
  • GDMA2, DM1, DM2
  • Hepatitis B or C
  • HIV

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

Dilapan S
Other group
Description:
Placement of dilators
Treatment:
Device: Dilapan S

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems