Caesarean and Corticotherapy
Information source: University Hospital, Strasbourg, France
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neonatal Distress
Intervention: betamethasone (Drug); placebo (Other)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Hospital, Strasbourg, France Official(s) and/or principal investigator(s):
Bruno Langer, MD, Principal Investigator, Affiliation: Les Hôpitaux Universitaires de Strasbourg
Overall contact:
Bruno Langer, MD, Phone: 0333 88127503, Email: bruno.langer@chru-strasbourg.fr
Summary
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Neonatal respiratory distress
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Bruno Langer, MD, Phone: 0333 88127503, Email: bruno.langer@chru-strasbourg.fr
Le Parc Centre pour la Mère et l'Enfant, Colmar 68000, France; Recruiting
Richard Kutnahorsky, MD, Phone: 33389126092, Email: kutnahorsky@mac.com
Richard Kutnahorsky, MD, Principal 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, Sub-Investigator
Centre Hospitalier de Haguenau, Haguenau 67504, France; Recruiting
Vincent Zerr, MD, Phone: 00333.88.06.30.44, Email: vincent.zerr@ch-haguenau.fr
Vincent Zerr, MD, Principal 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, Sub-Investigator
Hôpital de Hasenrain, Mulhouse 68051, France; Recruiting
Philippe Weber, MD, Phone: 033389646977, Email: weberph@ch-mulhouse.fr
Laurence Keller, MD, Sub-Investigator
Philippe Weber, MD, Principal 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, Sub-Investigator
Cmco-Sihcus, Schiltigheim 67303, France; Recruiting
Germain Aissi, MD, Phone: 333 88628349, Email: germain.aissi@sihcus.fr
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, Sub-Investigator
Germain Aissi, MD, Principal Investigator
Olivier Garbin, MD, Sub-Investigator
Véronique Thoma, MD, Sub-Investigator
Olivier Pirello, MD, Sub-Investigator
Hôpital de Hautepierre, Strasbourg 67000, France; Recruiting
Bruno Langer, MD, Phone: 33388127503, Email: bruno.langer@chru-strasbourg.fr
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, Sub-Investigator
Bruno Langer, MD, Principal Investigator
Benoît Escande, MD, Sub-Investigator
Pierre Kuhn, MD, Sub-Investigator
Additional Information
Starting date: February 2007
Last updated: June 28, 2012
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