NCT01635439

Prostin and Propess in Induction of Labor

Induction of Labour: A Comparison Between Propess Vaginal Delivery System and Prostin E2 Vaginal Suppositories, A Randomized Controlled Trial.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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).

Detailed description

A controlled release hydrophilic matrix (Controlled Therapeutics Ltd., East Kilbride, Scotland) which provides a gradual release of dinoprostone (prostaglandin E2) was introduced in 1995 (Propess, Ferring Pharmaceuticals). This preparation is used for the initiation or enhancement of cervical ripening in women at or after term with a singleton pregnancy and a cephalic presentation. Prostaglandin E2 causes softening and dilatation of the cervix and subsequently produces uterine contractions which may induce labour.

Conditions

• Labor Pain

Interventions

Type	Name	Description
DRUG	Propess	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.
DRUG	Prostin E2	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.

Timeline

• Start date: 2010-12-01
• Primary completion: 2011-11-01
• Completion: 2011-12-01
• First posted: 2012-07-09
• Last updated: 2014-02-06
• Results posted: 2012-10-04

Locations

1 site across 1 country: Saudi Arabia