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Steroid before early C-Section may prevent baby breathing issues and emergency deliveries

NCT ID NCT00446953

Prevention Sponsor: University Hospital, Strasbourg, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compared two groups of women having planned C-sections: one group had the surgery at 38 weeks after receiving two steroid shots (betamethasone) to speed up the baby's lung development, while the other group had the surgery at 39 weeks without steroids. The goal was to see if the 38-week approach could prevent emergency C-sections caused by labor starting before the planned date, without increasing the risk of newborn breathing problems. The trial enrolled 200 women and tracked rates of neonatal respiratory distress.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
betamethasone (a steroid given to the mother to speed up baby's lung development)
What this could lead to
If it works, this could offer a safer way to schedule C-sections at 38 weeks, reducing emergency surgeries and newborn breathing problems.
What could go wrong
This is a small, completed Phase 4 trial with 200 participants, so results may not apply to all pregnancies. Steroids carry some risks, and the benefit may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

200 people

The number who actually took part.

Start date

Feb 2007

Finished

Nov 2013

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

newborn respiratory distress syndrome prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neonatal distress

Contacts and locations

Locations

  • Centre Hospitalier de Haguenau

    Haguenau, 67504, France

  • Cmco-Sihcus

    Schiltigheim, 67303, France

  • Hôpital de Hasenrain

    Mulhouse, 68051, France

  • Hôpital de Hautepierre

    Strasbourg, 67000, France

  • Le Parc Centre pour la Mère et l'Enfant

    Colmar, 68000, France