Prostin and Propess in Induction of Labor

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Labor Pain

Intervention / Treatment
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* Drug: Propess
* Drug: Prostin E2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Propess<br>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. | Drug: Propess<br>* 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.<br>* Other names: Intravaginal PGE2 insert;|
| Active Comparator: Prostin E2<br>PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository. | Drug: Prostin E2<br>* 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.<br>* Other names: Dinoprostone (PGE2)vaginal tablets.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction to Delivery Interval |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction to Onset of Labor Interval |  | 24 hours | 
| Uterine Hyper-stimulation Rate |  | 24 hours | 
| Need for Syntocinon Augmentation |  | 24 hours | 
| Normal Vaginal Delivery Rate |  | 24 hours |