Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess

Cervical Ripening Clinical Trial

Official title:

Randomized Study on Removable PGE2 Vaginal Insert Versus PGE2 Intravaginal Gel for Cervical Priming and Labour Induction in Term Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00545194
• Other study ID #: PROPESS Study
• Status: Completed
• Phase: Phase 3
• First received: October 16, 2007
• Last updated: October 16, 2007
• Start date: January 2002
• Est. completion date: October 2004

Study information

• Verified date: October 2007
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare two different preparation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• singleton pregnancy

• cephalic presentation

• gestation of more than 37 Weeks confirmed by ultrasound

• Bishop score less than 7

• Informed consent

Exclusion Criteria:

• previous cesarean section (scarred uterus)

• polyhydramnios

• multiple pregnancy

• fetal malformation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Ripening
• Labor, Induced

Intervention

Drug:
• Prostaglandin E2

Locations

Country	Name	City	State
France	Olympe de Gouges Women Health Centre, Bretonneau University Hospital	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (3)

El-Shawarby SA, Connell RJ. Induction of labour at term with vaginal prostaglandins preparations: a randomised controlled trial of Prostin vs Propess. J Obstet Gynaecol. 2006 Oct;26(7):627-30. — View Citation

Lyrenäs S, Clason I, Ulmsten U. In vivo controlled release of PGE2 from a vaginal insert (0.8 mm, 10 mg) during induction of labour. BJOG. 2001 Feb;108(2):169-78. — View Citation

Strobelt N, Meregalli V, Ratti M, Mariani S, Zani G, Morana S. Randomized study on removable PGE2 vaginal insert versus PGE2 cervical gel for cervical priming and labor induction in low-Bishop-score pregnancy. Acta Obstet Gynecol Scand. 2006;85(3):302-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of vaginal deliveries within the 48 hours after cervical ripening		48 hours
Secondary	Proportion of total vaginal deliveries		48 hours
Secondary	Vaginal deliveries at 12 hours, 24 hours and 36 hours		48 hours
Secondary	Number of hyperkinesia with or without fetal heart rate monitoring abnormalities		48 hours
Secondary	Number of hypertonia with or without fetal heart rate monitoring abnormalities		48 hours
Secondary	Apgar score at 5 min less or equal 7		48 hours
Secondary	Apgar score at 10 min less or equal 7		48 hours
Secondary	Arterial pH less or equal 7.20		48 hours
Secondary	Arterial base excess more than 12		48 hours
Secondary	Number of maternal post-partum haemorrhage		48 hours
Secondary	Time to reach 3cm cervical dilatation		48 hours