Prostin and Propess in Induction of Labor

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635439
• Other study ID #: NWAFH2010-1
• Status: Completed
• Phase: Phase 3
• First received: July 4, 2012
• Last updated: January 7, 2014
• Start date: December 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2014
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Saudi Arabia	NWAFH, North west Armed Forces Hospital	Tabuk

Sponsors (2)

Lead Sponsor	Collaborator
Ain Shams University	North West Armed Forces Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induction to Delivery Interval		24 hours	No
Secondary	Induction to Onset of Labor Interval		24 hours	Yes
Secondary	Uterine Hyper-stimulation Rate		24 hours	Yes
Secondary	Need for Syntocinon Augmentation		24 hours	No
Secondary	Normal Vaginal Delivery Rate		24 hours	No