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

Hypertension in Pregnancy Clinical Trial

— FETH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03648645
• Other study ID #: 35RC17_8837_FETH
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 25, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: July 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: November 1, 2023
• Est. primary completion date: November 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced

Intervention

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.

Locations

Country	Name	City	State
France	CHU Caen	Caen
France	CHU Lille	Lille
France	Hôpital Cochin (APHP)	Paris
France	CH St-Malo	Saint-Malo
France	CHU Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of blood pressure measurements per day and per week		Through study completion, an average of 9 months
Secondary	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
Secondary	Likert scale to assess medical staff's satisfaction		Through study completion, an average of 9 months