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UnknownNCT03648645

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Rennes University Hospital · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
DEVICESelf measurement of blood pressurePatients 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.

Timeline

Start date
2022-05-25
Primary completion
2023-11-01
Completion
2023-11-01
First posted
2018-08-27
Last updated
2023-07-28

Locations

5 sites across 1 country: France

Source: ClinicalTrials.gov record NCT03648645. Inclusion in this directory is not an endorsement.