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

R

Rennes University Hospital

Status

Active, not recruiting

Conditions

Hypertension in Pregnancy

Treatments

Device: Self measurement of blood pressure

Study type

Interventional

Funder types

Other

Identifiers

NCT03648645
35RC17_8837_FETH

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

AH Telemonitoring
Experimental group
Description:
Self measurement of blood pressure
Treatment:
Device: Self measurement of blood pressure

Trial contacts and locations

5

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Central trial contact

Thierry DENOLLE, MD; Cathy DREXLER

Data sourced from clinicaltrials.gov

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