NCT00383942: RIPE

Ripening Interventions: Prostaglandins vs EASI Catheter

Terminated Phase 4 Results posted Last updated 13 March 2017

What this trial tests

Phase 4 trial testing Misoprostol in Cesarean Section in 80 participants. Terminated before completion.

Timeline

31 August 2006

Primary endpoint
18 June 2008

18 June 2008

Quick facts

Lead sponsor	Loyola University
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	80
Start date	31 August 2006
Primary completion	18 June 2008
Estimated completion	18 June 2008
Sites	1 location across United States

Drugs / interventions tested

• Misoprostol (Misoprostol) — full drug profile →
• Catheter

Conditions studied

• Cesarean Section — all drugs for Cesarean Section →

Sponsor

Loyola University

Who can join

18 and older, female only, with Cesarean Section. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Women Undergoing Cesarean Section for Fetal Intolerance of Labor Primary · At time of delivery

The number of women undergoing cesarean section will be compared between the misoprostol arm and EASI arm. The primary hypothesis is that the odds of receiving a cesarean section is lower among patients assigned to EASI when compared to patients who receive misoprostol.

Group	Value	95% CI
Misoprostol	0
EASI	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected for 1 year, 9 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Misoprostol

Serious: 0/40 (0%)

Deaths: 0/40

EASI

Serious: 0/40 (0%)

Deaths: 0/40

Other adverse events (1 terms — click to expand)

Reaction	System	Misoprostol	EASI
Pre-eclampsia	Pregnancy, puerperium and perinatal conditions	—	—

Data from ClinicalTrials.gov NCT00383942 adverse events section.

Sponsor's own description

The primary aim of this randomized clinical trial is to compare the effect of misoprostol vs extra amniotic saline infusion via a catheter (EASI) for cervical ripening on the proportion of patients delivered by cesarean section for fetal intolerance of labor versus vaginal delivery. The primary hypothesis is that patients undergoing cervical ripening with EASI catheter are less likely to undergo cesarean section for fetal intolerance of labor when compared to women who receive misoprostol.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.