Neonatal DistressPhase 4NCT00446953
Caesarean and Corticotherapy
A Phase 4 study testing betamethasone in people with Neonatal Distress, run by University Hospital, Strasbourg, France at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Neonatal Distress
- What is being tested?
- betamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 5 sitesFrance
- Study dates
- Feb 2007to Nov 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- woman who needs elective caesarean section
Who cannot join
- multiple pregnancy
- toxaemia
- rhesus immunization
- fetal infection
- maternal gastro-duodenal ulcer
- mother HIV+
- prior injection of corticosteroid during the pregnancy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Le Parc Centre pour la Mère et l'Enfant
Colmar, 68000
Centre Hospitalier de Haguenau
Haguenau, 67504
Hôpital de Hasenrain
Mulhouse, 68051
Cmco-Sihcus
Schiltigheim, 67303
Hôpital de Hautepierre
Strasbourg, 67000
About this 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.
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.
- Conditions
- Neonatal Distress
- Being tested
- betamethasone, placebo
- Keywords
- Caesarean section, Corticosteroids, Betamethasone, Neonatal distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
betamethasoneDrug
2x12 mg betamethazone c-section at 38 weeks
placeboOther
c-section at 39 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 2x 12 mg betamethazone Receives: Drug: betamethasone |
| 2 | Placebo comparator | no drugs Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal respiratory distress
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionOct 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Langer, MD, Principal investigator, Les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00446953
- Sponsor's protocol ID
- 3740
- Status last verified
- Dec 2025
- First submitted
- 12 Mar 2007
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Sananes N, Koch A, Escande B, Aissi G, Fritz G, Roth E, Weil M, Bakri A, Bolender C, Meyer N, Vayssiere C, Gaudineau A, Nisand I, Favre R, Kuhn P, Langer B. Pilot randomised controlled trial comparing the risk of neonatal respiratory distress in elective caesarean section at 38 weeks' gestation following a course of corticosteroids versus caesarean at 39 weeks. Eur J Obstet Gynecol Reprod Biol. 2017 May;212:54-59. doi: 10.1016/j.ejogrb.2017.03.020. Epub 2017 Mar 10.
PubMed 28342389
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00446953
- Acronym / sponsor ID
- 3740
- Conditions
- Neonatal Distress
- Keywords
- Caesarean section, Corticosteroids, Betamethasone, Neonatal distress
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 13 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: betamethasone2x 12 mg betamethazone |
| 2 | Placebo comparator | Other: placebono drugs |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- woman who needs elective caesarean section
Key exclusion criteria (7 listed)
- multiple pregnancy
- toxaemia
- rhesus immunization
- fetal infection
- maternal gastro-duodenal ulcer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| betamethasone2x12 mg betamethazone c-section at 38 weeks | Drug | 1 |
| placeboc-section at 39 weeks | Other | 2 |
Primary outcome
Neonatal respiratory distress
Time frame: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Results publication: PubMed 28342389Sananes N, Koch A, Escande B, Aissi G, Fritz G, Roth E, Weil M, Bakri A, Bolender C, Meyer N, Vayssiere C, Gaudineau A, Nisand I, Favre R, Kuhn P, Langer B. Pilot randomised controlled trial comparing the risk of neonatal respiratory distress in elective caesarean section at 38 weeks' gestation following a course of corticosteroids versus caesarean at 39 weeks. Eur J Obstet Gynecol Reprod Biol. 2017 May;212:54-59. doi: 10.1016/j.ejogrb.2017.03.020. Epub 2017 Mar 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Langer, MD principal investigator
Les Hôpitaux Universitaires de Strasbourg
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing betamethasone in people with Neonatal Distress, run by University Hospital, Strasbourg, France at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal respiratory distress (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00446953, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.