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

Tracking Information

First Received Date ^ICMJE

October 16, 2007

Last Updated Date

October 16, 2007

Start Date ^ICMJE

January 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Percentage of vaginal deliveries within the 48 hours after cervical ripening [ Time Frame: 48 hours ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Proportion of total vaginal deliveries [ Time Frame: 48 hours ]
Vaginal deliveries at 12 hours, 24 hours and 36 hours [ Time Frame: 48 hours ]
Number of hyperkinesia with or without fetal heart rate monitoring abnormalities [ Time Frame: 48 hours ]
Number of hypertonia with or without fetal heart rate monitoring abnormalities [ Time Frame: 48 hours ]
Apgar score at 5 min less or equal 7 [ Time Frame: 48 hours ]
Apgar score at 10 min less or equal 7 [ Time Frame: 48 hours ]
Arterial pH less or equal 7.20 [ Time Frame: 48 hours ]
Arterial base excess more than 12 [ Time Frame: 48 hours ]
Number of maternal post-partum haemorrhage [ Time Frame: 48 hours ]
Time to reach 3cm cervical dilatation [ Time Frame: 48 hours ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

The aim of this study is to compare two different preparation

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cervical Ripening
Labor, Induced

Intervention ^ICMJE

Drug: Prostaglandin E2

Study Arms / Comparison Groups

Active Comparator: sustained release preparation of prostaglandin E2
Active Comparator: short-acting (instant-released) preparation of prostaglandin E2

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

446

Completion Date

October 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00545194

Responsible Party

Study ID Numbers ^ICMJE

PROPESS Study

Study Sponsor ^ICMJE

Institut National de la Santé Et de la Recherche Médicale, France

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Franck Perrotin, MD-PhD

Tours Universiity Hospital

Information Provided By

Institut National de la Santé Et de la Recherche Médicale, France

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP