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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Hypertension in Pregnancy

Intervention / Treatment
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* Device: Self measurement of blood pressure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AH Telemonitoring<br>Self measurement of blood pressure | Device: Self measurement of blood pressure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypertension specific intervention | Percentage of blood pressure measurements initially planned and actually performed during the course of the investigation | Through study completion, an average of 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of blood pressure measurements per day and per week |  | 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) | Through study completion, an average of 9 months | 
| Likert scale to assess medical staff's satisfaction |  | Through study completion, an average of 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Hypertension, telemonitoring