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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 deliveries

Vaginal 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

Page last updated: June 20, 2008

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