Prostin and Propess in Induction of Labor

Phase 3

Completed

• Conditions: Labor Pain
• Interventions: Drug: Propess; Drug: Prostin E2

• Registration Number: NCT01635439
• Lead Sponsor: Ain Shams University

Brief 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.

Study Timeline

• Study Start: 2010-12
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Study First Submitted: 2012-07-04
• Study First Submitted QC: 2012-07-06
• Results First Submitted: 2012-07-06
• Study First Posted: 2012-07-09
• Results First Submitted QC: 2012-09-03
• Results First Posted: 2012-10-04
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-07
• Last Update Posted: 2014-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Gestational age 37 weeks or more
• Singleton pregnancy
• Cephalic presentation.

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Exclusion Criteria

• Previous cesarean section
• Any contraindication for vaginal delivery
• Suspected Cephalo-Pelvic Disproportion
• Unexplained antepartum Hemorrhage

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propess	Propess	Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h.
Prostin E2	Prostin E2	PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.

Primary Outcome Measures

Name	Time	Method
Induction to Delivery Interval	24 hours

Secondary Outcome Measures

Name	Time	Method
Uterine Hyper-stimulation Rate	24 hours
Induction to Onset of Labor Interval	24 hours
Need for Syntocinon Augmentation	24 hours
Normal Vaginal Delivery Rate	24 hours

Trial Locations

Locations (1)

NWAFH, North west Armed Forces Hospital; 🇸🇦 Tabuk, Saudi Arabia