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Primary hyperaldosteronism confers a higher risk of cardiovascular complications compared to essential hypertension. Preliminary data is controversial in regards of excessive maternal fetal and neonatal excessive risks in pregnancy.
This study aims at establishing the prevalence of PHA in an population with a recent episode of hypertensive disorder of pregnancy (HDP). The goal is to determine if a universal screening for PHA after a HDP is worthed. The investigators also wish to evaluate the complication rate in pregnant women with PHA compared to women without PHA.
This is a prospective cohort study where all eligible women will be screened for PHA after a HDP episode in the last pregnancy. We will then compare PHA women to non PHA women according to pregnancy complications.
This is a pilot study to evaluate feasibility and proof of concept. This is a prospective multicenter cohort study. Two university centers will participate (Sherbrooke and Montreal).
Participants will be recruited from post-partum Obstetric Medicine clinic in two tertiary care centers. They will be included if they presented a hypertensive disorder of preganncy (HDP) in their last pregnacy (from 4 weeks to 24 months after delivery). Women with pheochromocytoma, Cushing syndrome, secondary hyperaldosteronism, and those who are currently pregnant will be excluded.
All participants will be screened for PHA (with an aldosterone/renin ratio) and if the screening test is positive, they will be referred to a specialist to confirm the diagnosis.
Data will be collected from the participants and their babies' charts. Demographic data, obstetrical data, delivery data, maternal/fetal/neonatal complications, and diagnostic of PHA data will be collected.
A convenient sample size of 200 women will be used. If the prevalence of HPA is 5% or more, this would justify a larger study.
Primary outcome: establish the prevalence of PHA in women with a hypertensive disorders of pregnancy in last pregancy.
Secondary outcome include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Hyperaldosteronism Diagnosed Women | Post-partum women who had a hypertensive disorder of pregnancy and a screened primary hyperaldosteronism (positive aldosterone/renin ratio). |
| |
| Control Women | Post-partum women who had a hypertensive disorder of pregnancy without underlying primary hyperaldosteronism (negative aldosterone/renin ratio) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aldosterone/Renin Ratio | Diagnostic Test | Blood sample collected to measure the aldosterone/renin ratio for the primary hyperaldosteronism screening. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary hyperaldosteronism (PHA) prevalence in pregnant women with hypertensive disorders of pregnancy. | Prevalence of PHA in women with a hypertensive disorder of pregnancy in last pregnancy | Screening done between 4 and 24 weeks post-partum |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal and fetal impacts of PHA on hypertensive disorders of pregnancy | Comparison of the prevalence of each pre-specified complications (obstetrical, maternal, fetal, neonatal) between the PHA group and the non-PHA group. | During last pregnancy and 6 weeks postpartum |
| Prevalence of PHA for each hypertensive disorder of pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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Post-partum women who are followed in a specialized post-partum clinic in Montreal or Sherbrooke (Qc, Canada) for their hypertensive disorder during their latest pregnancy.
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| Name | Affiliation | Role |
|---|---|---|
| Nadine Sauvé, MD | Université de Sherbrooke | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hopitalier Universiatire de Sherbrooke | Sherbrooke | Quebec | J1H 5N4 | Canada | ||
| Centre Hospitalier Universitaire de Sherbrooke |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33393127 | Background | Alam S, Kandasamy D, Goyal A, Vishnubhatla S, Singh S, Karthikeyan G, Khadgawat R. High prevalence and a long delay in the diagnosis of primary aldosteronism among patients with young-onset hypertension. Clin Endocrinol (Oxf). 2021 Jun;94(6):895-903. doi: 10.1111/cen.14409. Epub 2021 Feb 22. | |
| 24927294 | Background |
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| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| D014115 | Toxemia |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D007239 | Infections |
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Comparison of the prevalence of each HDP subtype (i.e. chronic hypertension, gestational hypertension, pre-eclampsia) |
| During last pregnancy and 6 weeks postpartum |
| Impact of the timing of PHA on hypertensive disorders of pregnancy | Comparison between pregnancy outcomes for PHA diagnosed before the pregnancy with those diagnosed in post-partum | During last pregnancy and 6 weeks postpartum |
| Sherbrooke |
| Quebec |
| J1H 5N4 |
| Canada |
| Magee LA, Pels A, Helewa M, Rey E, von Dadelszen P; Canadian Hypertensive Disorders of Pregnancy Working Group. Diagnosis, evaluation, and management of the hypertensive disorders of pregnancy: executive summary. J Obstet Gynaecol Can. 2014 May;36(5):416-41. doi: 10.1016/s1701-2163(15)30588-0. English, French. |
| 28554307 | Background | Turner K, Hameed AB. Hypertensive Disorders in Pregnancy Current Practice Review. Curr Hypertens Rev. 2017;13(2):80-88. doi: 10.2174/1573402113666170529110024. |
| 27682655 | Background | Umesawa M, Kobashi G. Epidemiology of hypertensive disorders in pregnancy: prevalence, risk factors, predictors and prognosis. Hypertens Res. 2017 Mar;40(3):213-220. doi: 10.1038/hr.2016.126. Epub 2016 Sep 29. |
| 27156905 | Background | Landau E, Amar L. Primary aldosteronism and pregnancy. Ann Endocrinol (Paris). 2016 Jun;77(2):148-60. doi: 10.1016/j.ando.2016.04.009. Epub 2016 May 6. |
| 35569086 | Background | Downie E, Shanmugalingam R, Hennessy A, Makris A. Assessment and Management of Primary Aldosteronism in Pregnancy: A Case-Control Study. J Clin Endocrinol Metab. 2022 Jul 14;107(8):e3152-e3158. doi: 10.1210/clinem/dgac311. |
| 19171690 | Background | Escher G. Hyperaldosteronism in pregnancy. Ther Adv Cardiovasc Dis. 2009 Apr;3(2):123-32. doi: 10.1177/1753944708100180. Epub 2009 Jan 26. |