Swiss Postpartum Hypertension Cohort
ConditionPostpartum Hypertension (PPHT)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
This open label, prospective observational, single-center registry is to study short-, intermediate-and long-term course of postpartum hypertension and predictors/risk factors associated with long term cardiovascular and renal risk.
Current disease management strategies will be evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
all women with hypertensive disorders of pregnancy
postpartum hypertension (blood pressure measurements of systolic ≥140 and/or diastolic ≥ 90mmHg or antihypertensive therapy within the first 14 days after delivery)
women with preexisting hypertension or
women on antihypertensive medication
Disqualifiers
delivery > 14 days
lack of consent to participate in the study, language barriers or lack of general understanding
Trial population
The study will take place at the Hypertension Clinic of the Medical Outpatient Department at the University Hospital Basel and the Department of Obstetrics and Gynaecology at the University Hospital Basel. Participants will be consecutively screened and recruited by the treating physicians and the Hypertension Team of the Hypertension Clinic.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Data collection for parameters of organ damage (cardiac and renal blood markers)
Other interventionBlood results will be taken out of next routine venipuncture. Routinely collected standard parameters are a blood count, chemistry panel including renal parameters and electrolytes, lipid profile and a HbA1c as well as albumin/creatinine and protein/creatinine ratio in urine.
Data collection for blood pressure (BP)
Other interventionClinic blood pressure and 24hour BP Measurements
Home-based blood pressure management (substudy)
Other interventionSubjects participating in home-based blood pressure management via telemonitoring will receive a free HekaHealth application (App) for the structured assessment of HBPM.
Biomarker Profiles (substudy)
Other interventionSubstudy where possible cardiac, renal and pregnancy related biomarkers will be additionally analyzed. The following biomarkers will be analyzed: N terminal (NT)-proBNP, Troponin, elevated mid-regional pro-atrial natriuretic peptide (ANP), elevated mid-regional pro adrenomedullin (ADM), soluble fms-like tyrosine kinase (sFlt-1), and placenta growth factor (PlGF).
Data collection on patient reported outcomes
Other interventionData collection on patient reported outcomes (Questionnaire EQ-5D, Questionnaire for App based monitoring )
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Frequency of persistent hypertension defined by 24 hours BP measurement
Frequency of persistent hypertension defined by 24 hours BP measurement
Time frame
through study completion, an average of 5 years2
Frequency of persistent hypertension defined by office blood pressure measurement (OBPM, AOBPM)
Frequency of persistent hypertension defined by office blood pressure measurement (OBPM, AOBPM)
Time frame
through study completion, an average of 5 years3
Frequency of microalbuminuria
Frequency of microalbuminuria
Time frame
through study completion, an average of 5 years4
Frequency of damage to the retina of the eyes (retinopathy)
Frequency of damage to the retina of the eyes (retinopathy)
Time frame
through study completion, an average of 5 yearsSponsors and contacts
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Source ClinicalTrials.gov