RecruitingACTRN12624000819527

Administrative intervention to support testing after gestational diabetes and hypertensive disorders in pregnancy

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


Sponsor

Prof Michelle Giles, Department of Obstetrics, Monash Health, 246 Clayton Road, Melbourne, Vic 3168

Enrollment

144 participants

Start Date

Dec 21, 2023

Study Type

Interventional

Conditions

Summary

Women who have a diagnosis of gestational diabetes or hypertension in pregnancy are recommended to have further testing postpartum to review their longer term health risks; however, many women do not undergo testing in a timely manner due to many competing priorities. This study is evaluating whether an intervention providing administrative assistance can improve attendance and testing in the post partum period. Participants in the POST-IT study are randomly allocated to receive standard of care (usual advice with no administrative assistance) or intervention (assistance to book GP visit and recommended testing after GDM or HDP). Attendance rates, uptake of testing, and acceptability of the intervention will be evaluated at four months' postpartum via telephone survey.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

Women who develop gestational diabetes (GDM) or high blood pressure (hypertensive disorders of pregnancy, HDP) during pregnancy are at increased risk of type 2 diabetes and cardiovascular disease later in life. Postnatal check-ups and blood tests are strongly recommended to catch these risks early — but in practice, many women miss these follow-up appointments due to the demands of new parenthood. This study is testing whether a simple administrative intervention — help with booking a GP appointment and the recommended tests — can increase the number of women who actually complete their postnatal screening. Participants will be randomly assigned to receive either standard care (usual advice) or practical assistance with scheduling. You may be eligible if you were diagnosed with gestational diabetes or pregnancy-related high blood pressure during your current pregnancy and are receiving antenatal care at the study site. Women under 18, with pre-existing diabetes or hypertension, or planning to complete postpartum care outside Victoria would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The intervention consists of personalised administrative assistance to attend the recommended postpartum 6-week GP review and undergo recommended postpartum testing after gestational diabetes (GDM) an

The intervention consists of personalised administrative assistance to attend the recommended postpartum 6-week GP review and undergo recommended postpartum testing after gestational diabetes (GDM) and hypertensive disorders of pregnancy (HDP) in keeping with current recommendations. This will include: 1. Booking the appointment with the participant's GP at a day and time of their choosing 2. Provision of pathology forms for oral glucose tolerance test (OGTT) (if GDM); and for 24 hour blood pressure monitor, urinary protein:creatinine ratio and blood tests for fasting lipids and glucose (if HDP). 4. Booking of OGTT (if GDM) at pathology centre of participant's choice at 12 weeks postpartum. The participant will be provided with a single page summary of the appointments. The personalised administrative assistance is provided by the PhD student investigator on the study team. This is provided either at or after 36 weeks for those recruited antenatally, and within one week postpartum for those recruited postpartum. Fidelity to the intervention will be assessed primarily at the four month survey for all participants. A subset will also undergo validation by correspondence with the participant's GP, for those who provide consent to do so during the participant recruitment and consent process. Validation involves the following: no active participation from participants. Contact with consenting participants' primary care practitioner will be performed for this subset, and data on a. whether a six week visit was performed; b. whether an OGTT or other diabetes screening test has been performed postpartum, and when (for those with GDM); and c. whether additional testing after hypertensive disorder in pregnancy has been performed, and which tests these are. The timing of this subset validation will be: six months postpartum, i.e. two months following the participant's four month survey.


Locations(3)

Monash Medical Centre - Clayton campus - Clayton

VIC, Australia

Casey Hospital - Berwick

VIC, Australia

Dandenong Hospital- Monash Health - Dandenong

VIC, Australia

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ACTRN12624000819527