CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 200 enrolled
Drug / intervention
Propess +1 moredrug
Likely dose
Prostin E2 3 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01635439
NCT01635439Phase 3Completed
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Induction of Labour: A Comparison Between Propess Vaginal Delivery System and Prostin E2 Vaginal Suppositories, A Randomized Controlled Trial.

Ain Shams University·interventional·Posted Jul 9, 2012·Updated Feb 6, 2014

In Brief

A Phase 3 clinical trial evaluating Propess and Prostin E2 for Labor Pain. Completed, enrolled 200 participants across 1 site.

Detailed Summary

The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2 (Dinoprostone vaginal Tablet).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLabor Pain
CountriesSaudi Arabia
CollaboratorsNorth West Armed Forces Hospital

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 9, 2012
Enrollment StartDec 1, 2010
Primary CompletionNov 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 14.0 years ago

Interventions

Propessdrug

The vaginal insert is removed 24 h after the application. It is only to be removed earlier in case of the onset of active labour, the rupture of the membranes, or at the occurrence of hyperstimulation.

Prostin E2drug

3 mg tab is placed in the posterior vaginal fornix. dose can be repeated every 6 hours till onset of active labour, the rupture of the membranes, or the occurrence of hyper-stimulation.