ACTRN12624000819527RecruitingUnknown
POST-IT: A randomised controlled trial to evaluate a POSTpartum Intervention to support adherence to recommended Testing in women diagnosed with gestational diabetes and hypertensive disorders
Prof Michelle Giles, Department of Obstetrics, Monash Health, 246 Clayton Road, Melbourne, Vic 31680 sites144 target enrollmentStarted: July 3, 2024Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Enrollment
- 144
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Diagnosis
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (—)
- Sex
- Female
Inclusion Criteria
- •Planning to receive all antenatal care at site of study recruitment
- •Diagnosed with HDP or GDM at any point during pregnancy
Exclusion Criteria
- •Aged <18 years
- •Past history of hypertension, Type 1 or Type 2 diabetes or Mature Onset Diabetes of the Young (MODY) that predates current pregnancy and for which they receive long term healthcare follow up
- •Diagnosis of severe GDM or HDP with activation of alternative specialist postpartum pathways: endocrinologist (GDM with complex management needs or concern for pre-existing Type 1 diabetes or MODY); or nephrologist (severe pre-eclampsia, eclampsia, or Haemolysis/Elevated Liver enzymes/Low platelets HELLP syndrome).
- •Residence interstate/overseas and planning to complete postpartum care outside of Victoria.
- •Women who have had a fetal death in utero or stillbirth; if already recruited, then they will automatically be withdrawn from the study.
- •Women who have complex medical or psychiatric needs in the peripartum period requiring extended stay (> two weeks, or > one week in Intensive Care Unit) postpartum; or otherwise deemed unsuitable at the discretion of the researcher/clinician.
- •Women who are incarcerated, who do not speak English and there is no interpreter available to obtain consent
- •Women who give birth prior to 32 weeks where an alternate postpartum pathway is in situ for follow-up
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