Trans-cervical cervical balloon for Induction of Labour

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Induction of LabourTrans-cervical cervical balloon - Device
Eligibility
18 - 40
Female
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Study Summary

This trial is comparing two methods of inducing labor: one mechanical and one with medication.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 720-2160 minutes

12-14 hours
Pain over duration of cervical ripening
Rate of device expulsion prior to admission
Rate of onset of labor prior to planned admission
12-36 hours
10 minute Apgar score <7
Base excess >12
Incidence of intra-amniotic infection
Incidence of post-partum hemorrhage
Incidence of shoulder dystocia
Rate of cesarean delivery
Rate of operative vaginal delivery
Umbilical cord gas pH <7
12-72 hours
Composite score of adverse neonatal outcomes
Composite score of serious maternal morbidity or mortality
24-36 hours
Patient satisfaction with cervical ripening agent
720-2160 minutes
Time from start of cervical ripening to delivery
First hour
Pain of insertion

Trial Safety

Trial Design

2 Treatment Groups

Hygroscopic cervical dilators
1 of 2
Trans-cervical cervical balloon
1 of 2

Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: Trans-cervical cervical balloon · No Placebo Group · N/A

Hygroscopic cervical dilators
Device
Experimental Group · 1 Intervention: Hygroscopic cervical dilator · Intervention Types: Device
Trans-cervical cervical balloon
Device
Experimental Group · 1 Intervention: Trans-cervical cervical balloon · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 720-2160 minutes

Who is running the clinical trial?

Ochsner Health SystemLead Sponsor
88 Previous Clinical Trials
185,483 Total Patients Enrolled
Northwell HealthOTHER
425 Previous Clinical Trials
493,230 Total Patients Enrolled
Brigid McCue, MDPrincipal InvestigatorNorthwell Health

Eligibility Criteria

Age 18 - 40 · Female Participants · 1 Total Inclusion Criteria

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References