Caesarean and Corticotherapy - Full Text View

Sponsored by:	University Hospital, Strasbourg, France
Information provided by:	University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:	NCT00446953

Purpose

Comparison of two randomized group :

caesarean section planned at 38 weeks after 2 antenatal injections of 12 mg of betamethasone 48 h before.
caesarean section planned at 39 weeks without corticosteroid.

The aim is to demonstrate that programming caesarean section at 38 weeks of pregnancy, after antenatal corticosteroid, allows to avoid caesarean section in emergency (because of a labour before 39 weeks), without increasing the neonatal respiratory distress rate.

Condition	Intervention	Phase
Neonatal Distress	Drug: betamethasone Other: placebo	Phase IV

MedlinePlus related topics: Cesarean Section

Drug Information available for: Corticosteroids Betamethasone Bentelan Betamethasone dipropionate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study
Official Title:	Interest in Programming Caesarean Section at 38 Weeks of Pregnancy With Antenatal Betamethasone to Prevent Neonatal Respiratory Distress and to Avoid Emergency Caesarean Section Before Planned Date.

Further study details as provided by University Hospital, Strasbourg, France:

Primary Outcome Measures:

Neonatal respiratory distress [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	600
Study Start Date:	March 2007
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 2x 12 mg betamethazone	Drug: betamethasone 2x12 mg betamethazone c-section at 38 weeks
2: Placebo Comparator no drugs	Other: placebo c-section at 39 weeks

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

woman who needs elective caesarean section

Exclusion Criteria:

multiple pregnancy
toxaemia
rhesus immunization
fetal infection
maternal gastro-duodenal ulcer
mother HIV+
prior injection of corticosteroid during the pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446953

Contacts

Contact: Bruno Langer, MD	0333 88127503	bruno.langer@chru-strasbourg.fr
Contact: Nicolas Sananès, Resident		nsananes@hotmail.com

Locations

France
Hôpital de Hautepierre	Recruiting
Strasbourg, France, 67000
Contact: Bruno Langer, MD 33388127503 bruno.langer@chru-strasbourg.fr
Sub-Investigator: Jean-Jacques Baldauf, MD
Sub-Investigator: Françoise Brand, MD
Sub-Investigator: Eric Boudier, MD
Sub-Investigator: Eric David, MD
Sub-Investigator: Gabrielle Fritz, MD
Sub-Investigator: Christine Helmlinger, MD
Sub-Investigator: Brigitte Viville, MD
Sub-Investigator: Emmanuelle Baulon, MD
Principal Investigator: Bruno Langer, MD
Sub-Investigator: Benoît Escande, MD
Sub-Investigator: Pierre Kuhn, MD
CMCO-SIHCUS	Recruiting
Schiltigheim, France, 67303
Contact: Germain Aissi, MD 333 88628349 germain.aissi@sihcus.fr
Sub-Investigator: Michèle Weil, MD
Sub-Investigator: Romain Favre, MD
Sub-Investigator: Catherine Rongières, MD
Sub-Investigator: Jeanine Ohl, MD
Sub-Investigator: Karima Bettahar, MD
Sub-Investigator: Monique Kohler, MD
Principal Investigator: Germain Aissi, MD
Sub-Investigator: Olivier Garbin, MD
Sub-Investigator: Véronique Thoma, MD
Sub-Investigator: Olivier Pirello, MD
Le Parc Centre pour la Mère et l'Enfant	Recruiting
Colmar, France, 68000
Contact: Richard Kutnahorsky, MD 33389126092 kutnahorsky@mac.com
Principal Investigator: Richard Kutnahorsky, MD
Sub-Investigator: Didier Chognot, MD
Sub-Investigator: Jean-Luc Gollner, MD
Sub-Investigator: Laurent Beinert, MD
Sub-Investigator: Stéphane Lucas, MD
Sub-Investigator: Martine Macchi-Gerrer, MD
Sub-Investigator: Jean-Marc Renglewicz, MD
Sub-Investigator: Jean-Yves Egloff, MD
Sub-Investigator: Michel Schiltz, MD
Sub-Investigator: Elie Haidar, MD
Hôpital de Hasenrain	Recruiting
Mulhouse, France, 68051
Contact: Philippe Weber, MD 033389646977 weberph@ch-mulhouse.fr
Sub-Investigator: Laurence Keller, MD
Principal Investigator: Philippe Weber, MD
Sub-Investigator: Jean Nakhleh, MD
Sub-Investigator: Zafer Kara, MD
Sub-Investigator: Charles Gilliot, MD
Sub-Investigator: Edgar Montoya, MD
Sub-Investigator: Francine Achatz, MD
Sub-Investigator: Anne Fleury, MD
Sub-Investigator: Francisco Delpiano, MD
Sub-Investigator: Didier Cohen, MD
Sub-Investigator: Bernard Ott, MD
Centre Hospitalier de Haguenau	Recruiting
Haguenau, France, 67504
Contact: Vincent Zerr, MD 00333.88.06.30.44 vincent.zerr@ch-haguenau.fr
Principal Investigator: Vincent Zerr, MD
Sub-Investigator: Abdou Chami, MD
Sub-Investigator: Michel Foegle, MD
Sub-Investigator: Etienne Keller, MD
Sub-Investigator: Ahmad Bakri, MD
Sub-Investigator: Michèle Lehmann, MD
Sub-Investigator: Karim Dadoun, MD
Sub-Investigator: Chantal Bolender, MD
Sub-Investigator: Marie-Pierre Streicher, MD

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

Principal Investigator:

Bruno Langer, MD

Les Hôpitaux Universitaires de Strasbourg

More Information

Responsible Party:	University Hospital, Strasbourg, France ( Emmanuel Lavoué, Directeur Adjoint de la Recherche Clinique et de l'Innovation )
Study ID Numbers:	3740
Study First Received:	March 12, 2007
Last Updated:	January 23, 2008
ClinicalTrials.gov Identifier:	NCT00446953
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:

Caesarean section
Corticosteroids
Betamethasone
Neonatal respiratory distress

Study placed in the following topic categories:

Betamethasone-17,21-dipropionate
Sodium phosphate
Betamethasone sodium phosphate
Emergencies
Betamethasone

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents
Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009