Fetal focus: fetal intramuscular steroids for diabetic women at risk of preterm birth

Phase 2

• Conditions: Preterm birth; Diabetes in pregnancy; Reproductive Health and Childbirth - Fetal medicine and complications of pregnancy; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12616001577404
• Lead Sponsor: Women and Newborns Health Service

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

Pregnant woman
Pregestational type 1 or type 2 diabetes mellitus
Delivery indicated between 34w0d and 36w6d gestation
Treating clinician feels that antenatal corticosteroid therapy is indicated
Fetus accessible for intramuscular injection

Exclusion Criteria

Age < 18 years
Unable to provide informed consent
Known fetal anomaly
Multiple pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of either:<br>(a) maternal hyperglycaemia, defined as fasting glucose > 5.0 mmol/L or 2h postprandial glucose > 6.6 mmol/L requiring an increase in insulin dose, or <br>(b) maternal ketoacidosis, defined as positive capillary ketone test or arterial pH < 7.3[Within 48 hours of first dose]

Secondary Outcome Measures

Name	Time	Method
eonatal respiratory morbidity, defined as requirement of at least 2 hours of supplemental oxygen therapy, continuous positive airway pressure, mechanical ventilator support, or surfactant therapy[Hospital discharge];Cord blood insulin[Birth];Neonatal hypoglycaemia requiring treatment by supplemental feeding or intravenous therapy[Hospital discharge];Neonatal sepsis, defined as raised c-reactive protein and requirement for antibiotic therapy[Hospital discharge];Maternal infectious morbidity, defined as requirement for antibiotic treatment[6 weeks]