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

This study has been completed.

First Received: October 16, 2007 No Changes Posted

Sponsored by:	Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:	Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:	NCT00545194

Purpose

The aim of this study is to compare two different preparation

Condition	Intervention	Phase
Cervical Ripening Labor, Induced	Drug: Prostaglandin E2	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Study on Removable PGE2 Vaginal Insert Versus PGE2 Intravaginal Gel for Cervical Priming and Labour Induction in Term Pregnancy

Resource links provided by NLM:

Drug Information available for: Dinoprostone

U.S. FDA Resources

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	446
Study Start Date:	January 2002
Study Completion Date:	October 2004

Arms	Assigned Interventions
A: Active Comparator sustained release preparation of prostaglandin E2	Drug: Prostaglandin E2
B: Active Comparator short-acting (instant-released) preparation of prostaglandin E2	Drug: Prostaglandin E2

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545194

Locations

France
Olympe de Gouges Women Health Centre, Bretonneau University Hospital
Tours, France, 37044

Sponsors and Collaborators

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

Investigators

Principal Investigator:

Franck Perrotin, MD-PhD

Tours Universiity Hospital

More Information

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.

Study ID Numbers:	PROPESS Study
Study First Received:	October 16, 2007
Last Updated:	October 16, 2007
ClinicalTrials.gov Identifier:	NCT00545194 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Institut National de la Santé Et de la Recherche Médicale, France:

Prostaglandin E2
Intravaginal gel
Bishop score

Induction of labor
randomized trial
Vaginal insert

Study placed in the following topic categories:

Dinoprostone

Additional relevant MeSH terms:

Dinoprostone
Oxytocics
Therapeutic Uses

Physiological Effects of Drugs
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009