The CSTEROID 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 CSTEROID Trial.

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12618002028280

Acronym

C*STEROID Feasibility Study

Enrollment

Registered

2018-12-18

Start date

2019-06-21

Completion date

2020-03-17

Last updated

2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

14 Years to 55 Years

Healthy volunteers

Inclusion criteria

1. Women for whom caesarean section is planned pre-labour at 35+0 to 39+6 weeks gestation. 2. >24 hours and <7 days before planned birth. 3. Singleton or twin pregnancy.

Exclusion criteria

1. Diabetes: pre-existing or gestational. 2. Non-viable fetus or major fetal abnormality. 3. Prior corticosteroid use in this pregnancy.

Outcome results