Hypertensive Pregnant Women Monitored by Teletransmitted Self-measurements of Blood Pressure

Rennes University Hospital50 enrolled

Overview

The occurrence of arterial hypertension (AH) during pregnancy is a major cause of fetal, neonatal and maternal morbidity and mortality in western countries. It is estimated that about 10% of pregnancies are complicated by AH (80 000 women / year in France). It is therefore essential to diagnose AH with certainty in order to set-up appropriate care and follow its evolution.

The objective of this study is to show the faisability of self-measurement with teletransmission for long-term follow-up of hypertensive pregnant women (at high risk of preeclampsia) by avoiding repeated, prolonged visits or hospitalizations and to optimize the intervention of health professionals by providing them with reliable data. A multicenter, controlled study will be conducted in women presenting with mild to moderate hypertension without preeclampsia followed throughout their pregnancy by either self-measurement with teletransmission.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Hypertension in Pregnancy

Interventions

Self measurement of blood pressureDEVICE

Patients will perform the measurement of blood pressure at home, on a daily basis, in complying with the "rule of 3" stated by the Haute Autorité de Santé (French Health Authority) : i.e. 3 consecutive measurements in the morning and in the evening, after a period of rest Measurements are performed using a blood pressure monitor Bluetooth-connected. If a threshold value is exceeded (and depending on the alert), a consultation will be scheduled (unexpected consultation) and notified to the patient.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pregnant women with confirmed mild to moderate AH untreated and / or under antihypertensive treatment (for gestational or chronic hypertension) * Women without preeclampsia requiring enhanced AH surveillance * Patient affiliated to a social security system * Patient giving consent to participate in the study. * Age\> 18 years Exclusion Criteria: * arm circumference greater than 42 cm unsuitable for self-measurement, * women in atrial fibrillation, or frequently in arrhythmia, with secondary hypertension or severe hypertension or with cardiovascular complication. * women having preeclampsia. * women having an AH by "white coat effect". * women having a move or maternity change planned during pregnancy. * majors protected under tutorship or curatorship, or under the protection of justice.

Locations (5)

CHU Caen

Caen, France

CHU Lille

Lille, France

Hôpital Cochin (APHP)

Paris, France

CH St-Malo

St-Malo, France

CHU Tours

Tours, France

Outcomes

Primary Outcomes

Hypertension specific intervention

Percentage of blood pressure measurements initially planned and actually performed during the course of the investigation

Time frame: Through study completion, an average of 9 months

Secondary Outcomes

Number of blood pressure measurements per day and per week

Time frame: Through study completion, an average of 9 months

Likert scale to assess patients' satisfaction

Evaluation of the patients' satisfaction regarding their medical care during pregnancy assessed by Likert scale : from 1 (Very dissatisfied) to 5 (Very satisfied)

Time frame: Through study completion, an average of 9 months

Likert scale to assess medical staff's satisfaction

Time frame: Through study completion, an average of 9 months

Data from ClinicalTrials.gov

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