Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess
Information source: Institut National de la Santé Et de la Recherche Médicale, France
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cervical Ripening; Labor, Induced
Intervention: Prostaglandin E2 (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Institut National de la Santé Et de la Recherche Médicale, France Official(s) and/or principal investigator(s):
Franck Perrotin, MD-PhD, Principal Investigator, Affiliation: Tours Universiity Hospital
Summary
The aim of this study is to compare two different preparation
Clinical Details
Official title: Randomized Study on Removable PGE2 Vaginal Insert Versus PGE2 Intravaginal Gel for Cervical Priming and Labour Induction in Term Pregnancy
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percentage of vaginal deliveries within the 48 hours after cervical ripening
Secondary outcome: Proportion of total vaginal deliveriesVaginal deliveries at 12 hours, 24 hours and 36 hours Number of hyperkinesia with or without fetal heart rate monitoring abnormalities Number of hypertonia with or without fetal heart rate monitoring abnormalities Apgar score at 5 min less or equal 7 Apgar score at 10 min less or equal 7 Arterial pH less or equal 7.20 Arterial base excess more than 12 Number of maternal post-partum haemorrhage Time to reach 3cm cervical dilatation
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Olympe de Gouges Women Health Centre, Bretonneau University Hospital, Tours 37044, France
Additional Information
Related publications: Lyrenas 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. 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. 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.
Starting date: January 2002
Ending date: October 2004
Last updated: October 16, 2007
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