Caesarean and Corticotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University Hospital, Strasbourg, France
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00446953
First received: March 12, 2007
Last updated: September 6, 2013
Last verified: September 2013
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


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: February 2007
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
2x 12 mg betamethazone
Drug: betamethasone
2x12 mg betamethazone c-section at 38 weeks
Placebo Comparator: 2
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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         
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         
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         
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         
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         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Bruno Langer, MD Les Hôpitaux Universitaires de Strasbourg
  More Information

No publications provided

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00446953     History of Changes
Other Study ID Numbers: 3740
Study First Received: March 12, 2007
Last Updated: September 6, 2013
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Strasbourg, France:
Caesarean section
Corticosteroids
Betamethasone
Neonatal distress

Additional relevant MeSH terms:
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014