Prostin and Propess in Induction of Labor

NCT ID: NCT01635439

Last Updated: 2014-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2011-12-31

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.

Conditions

Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Propess

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Prostin E2

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Intravaginal PGE2 insert; Dinoprostone (PGE2)vaginal tablets.

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

North West Armed Forces Hospital

UNKNOWN

Sponsor Role: collaborator

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ellaithy

Lecturer of Obstetrics & Gynecology/ Consultant of Obstetrics & Gynecology AFHSR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Abdelaziz, M.D.

Role: PRINCIPAL_INVESTIGATOR

North West Armed Forces Hospital

Locations

NWAFH, North west Armed Forces Hospital

Tabuk, Tabuk Region, Saudi Arabia

Countries

Saudi Arabia

References

Abdelaziz A, Mahmoud AA, Ellaithy MI, Abees SH. Pre-induction cervical ripening using two different dinoprostone vaginal preparations: A randomized clinical trial of tablets and slow release retrievable insert. Taiwan J Obstet Gynecol. 2018 Aug;57(4):560-566. doi: 10.1016/j.tjog.2018.06.016.

Reference Type: DERIVED

PMID: 30122579 (View on PubMed)

Other Identifiers

NWAFH2010-1

Identifier Type: -

Identifier Source: org_study_id