Prostin and Propess in Induction of Labor

Ain Shams University

Status and phase: Completed; Phase 3

Conditions: Labor Pain

Treatments: Drug: Propess; Drug: Prostin E2

Study type: Interventional

Funder types: Other

Identifiers

NCT01635439

NWAFH2010-1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Propess

Active Comparator group

Description:

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.

Treatment:

Drug: Propess

Prostin E2

Active Comparator group

Description:

PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.

Treatment:

Drug: Prostin E2