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Postpartum intervention for cardio-kidney-metabolic outcomes after Hypertensive Disorders of Pregnancy Pilot Study

PIVOT-HDP (Postpartum intervention for cardio-kidney-metabolic outcomes after HDP) Pilot Study

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000198325
Acronym
PIVOT-HDP
Enrollment
50
Registered
2026-02-17
Start date
2026-04-01
Completion date
2026-12-31
Last updated
2026-03-02

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

Conditions

None listed

Brief summary

To assess the feasibility of implementing a structured postpartum follow up program for women with a pregnancy complicated by HDP. We hypothesize that a structured postpartum program is feasible, acceptable to consumers and cost effective.

Interventions

The PIVOT-HDP program begins before discharge, where participants are provided with the International Federation of Obstetrics and Gynaecology (FIGO) postpartum “Pregnancy Passport” (added to the Victorian Maternal and Child Health “green book”) and trained to use a validated home blood pressure monitor. Women are asked to measure their blood pressure daily for the first 2 weeks after birth (twice daily if out of range), then three times per week until 6 weeks, then monthly thereafter. Blood pre

The PIVOT-HDP program begins before discharge, where participants are provided with the International Federation of Obstetrics and Gynaecology (FIGO) postpartum “Pregnancy Passport” (added to the Victorian Maternal and Child Health “green book”) and trained to use a validated home blood pressure monitor. Women are asked to measure their blood pressure daily for the first 2 weeks after birth (twice daily if out of range), then three times per week until 6 weeks, then monthly thereafter. Blood pressure, symptoms, and current medications are entered into an online tool, which is monitored by a research nurse/midwife or clinician to support remote antihypertensive initiation and/or self-titration, with treatment adjustments triggered by elevated readings (e.g., >140/90 mmHg). Participants also complete five structured follow-up visits (baseline in hospital, then 2 weeks, 6 weeks, 6 months, and 12 months postpartum), delivered by telehealth or in person depending on preference, with review by a nurse practitioner or medical practitioner. Each visit will be approximately 30 minutes. To monitor adherence to follow up, session attendance checklist will be performed by research midwives. At 6 weeks, 6 months, and 12 months, participants complete blood and urine testing to assess cardio-kidney-metabolic risk factors (including renal function, urine Albumin to Creatinine Ratio [ACR], fasting glucose/lipids, Brain Natriuretic Peptide [BNP]/troponin, and renin/aldosterone testing), with additional investigations including a 24-hour ambulatory blood pressure (BP) monitor prior to the 6-month visit and an echocardiogram prior to the 12-month visit. Abnormal results are reviewed by a medical practitioner, recommendations are provided to the participant, and plans are communicated to the participant’s primary care provider; cardiovascular risk is also estimated using standard risk calculators. The total duration of home blood pressure measurements will be 12 months after birth. If participants record high blood pressure >140/90 research nurses/midwives will contact participants via phone call. Guided by study clinician, antihypertensives that will be initiated depends on whether the participant is breastfeeding. If breastfeeding, typical agents will be enalapril and nifedipine slow release. If not breastfeeding, then typical antihypertensive agents will be eg. perindopril, amlodipine. To monitor adherence to home blood pressure monitoring, an audit of the online tool will be performed by research midwives once per month during the study.

Sponsors

Monash Health
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

• Females 18 years or over with clinician confirmed diagnosis of HDP defined by Society of Obstetric Medicine of Australia and New Zealand guidelines. • Singleton and multiple gestation will be included

Exclusion criteria

• Significant kidney or hepatic impairment that would affect safe antihypertensive medication titration • Participant with life expectancy of less than 6 months or any other significant disease which may put the participant at risk through participation in the trial

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 14, 2026