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NCT00446953
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.
Phase 4 trial testing betamethasone in Neonatal Distress in 200 participants. Completed in 1 November 2013.
1 October 2013
Quick facts
| Lead sponsor | University Hospital, Strasbourg, France |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 200 |
| Start date | 1 February 2007 |
| Primary completion | 1 October 2013 |
| Estimated completion | 1 November 2013 |
| Sites | 5 locations across France |
Drugs / interventions tested
- betamethasone (BETAMETHASONE) — full drug profile →
- placebo
Conditions studied
- Neonatal Distress — all drugs for Neonatal Distress →
Sponsor
University Hospital, Strasbourg, France
Who can join
Eligibility, female only, with Neonatal Distress. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Neonatal respiratory distress
Time frame: 15 days
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
A conference report on prenatal corticosteroid use in low- and middle-income countries.
McClure EM, de Graft-Johnson J, Jobe AH, Wall S, et al · · 2011 · cited 8× · PMID 21930269 · DOI 10.1016/j.ijgo.2011.07.017
Verify or expand the search:
- PubMed search for NCT00446953
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other University Hospital, Strasbourg, France trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00446953 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Strasbourg, France
- Last refreshed: 15 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00446953.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing