Are you pregnant, planning a caesarean and have diabetes?
- Category
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Trial status
Recruiting
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Trial phase
Phase 3 Drug TrialLate stage studies conducted to confirm efficacy and safety of investigational therapies in large patient populations prior to introduction to clinical practice.
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ERM Project ID
85882
Trial contact details
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Contact person
Genesis Research Group
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Phone
0422 288 952
What you need to know
Who can take part?
INCLUSION:
Pregnant women:
- with diabetes, who are carrying one or two babies.
- plan to give birth by elective CS between 35+0 and 39+6 weeks gestation.
EXCLUSION:
- Known major fetal anomaly or chromosomal anomaly.
- Women who have received a steroid injection prior during this pregnancy.
- Women with a systemic fungal infection.
- Women with thrombocytopaenia - platelet count below 80x109 /litre
- Hypersensitivity or allergy to betamethasone sodium phosphate, betamethasone acetate, or other corticosteroids
- Other contraindications to corticosteroids
- Prior participation in the PRECeDe trial in a previous pregnancy (prior participation in the PRECeDe Pilot trial is NOT regarded as an exclusion from participation in the current trial).
What is involved for me?
- Read and sign the information and consent form.
- Attend three short questionnaires about your general health and pregnancy (These should take around 10 minutes).
- The research midwife will review your health information.
- You will be allocated into either the betamethasone or placebo (normal saline, aka salty water) injection group via a computer program.
- You will receive 2 injections, 24 hours apart within 7 days of your planned caesarean.
