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

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 1, 2023

Detailed Description

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.

Interventions

  • Device: Self measurement of blood pressure
    • 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.

Arms, Groups and Cohorts

  • Experimental: AH Telemonitoring
    • Self measurement of blood pressure

Clinical Trial Outcome Measures

Primary Measures

  • Hypertension specific intervention
    • Time Frame: Through study completion, an average of 9 months
    • Percentage of blood pressure measurements initially planned and actually performed during the course of the investigation

Secondary Measures

  • 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
    • Time Frame: Through study completion, an average of 9 months
    • Evaluation of the patients’ satisfaction regarding their medical care during pregnancy assessed by Likert scale : from 1 (Very dissatisfied) to 5 (Very satisfied)
  • Likert scale to assess medical staff’s satisfaction
    • Time Frame: Through study completion, an average of 9 months

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rennes University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Thierry DENOLLE, MD, Study Director, Hospital of Dinard

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