TerminatedPhase 3ACTRN12618002028280

The C*STEROID Feasibility Study: a two-site, randomised placebo controlled trial of corticosteroids before planned caesarean section delivery at 35+0 to 39+6 weeks of pregnancy to determine feasibility for recruitment to the C*STEROID Trial.

The C*STEROID Feasibility Study: Corticosteroids before planned caesarean section from 35+0 to 39+6 weeks


Sponsor

University of Auckland

Enrollment

400 participants

Start Date

Jun 21, 2019

Study Type

Interventional

Conditions

Summary

Birth by planned caesarean section poses some risk to babies, in particular, the need for admission to the neonatal unit for breathing support. Corticosteroid injections given to mothers expecting a preterm birth reduce neonatal respiratory morbidity but is not known if corticosteroids before a planned caesarean section at or near term have the same effect. Limited research suggests that as well as benefits on babies’ breathing these injections may lower babies’ blood sugar levels and so possibly cause harm. The C*STEROID Trial is a planned to be a multi-centre, placebo-controlled, randomised trial to assess the effects of corticosteroids given to mothers before a planned caesarean section at or near term on neonatal and childhood health. The C*STEROID Feasibility Study will take place in two maternity units over a 12 month period to identify key issues that may arise for women considering trial participation and for the researchers and medical professionals involved in the trial in practice. The hypothesis of the C*STEROID Feasibility Study is that women will be willing to take part in a trial of antenatal corticosteroids prior to planned caesarean section at 35+0 to 39+6 weeks.


Eligibility

Sex: FemalesMin Age: 14 YearssMax Age: 55 Yearss

Inclusion Criteria3

  • Women for whom caesarean section is planned pre-labour at 35+0 to 39+6 weeks gestation.
  • >24 hours and <7 days before planned birth.
  • Singleton or twin pregnancy.

Exclusion Criteria3

  • Diabetes: pre-existing or gestational.
  • Non-viable fetus or major fetal abnormality.
  • Prior corticosteroid use in this pregnancy.

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Interventions

Two doses of 11.4mg betamethasone by intramuscular injection into the thigh, arm or buttock, 24 hours apart given within seven days of planned caesarean section.

Two doses of 11.4mg betamethasone by intramuscular injection into the thigh, arm or buttock, 24 hours apart given within seven days of planned caesarean section.


Locations(1)

New Zealand

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ACTRN12618002028280


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