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

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 Overview

• Status: Active, not recruiting
• Conditions: Hypertension in Pregnancy
• Intervention / Treatment: Device: Self measurement of blood pressure

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thierry DENOLLE, MD
• Study Contact Backup: Name: Cathy DREXLER

Study Locations

• France
  • Caen, France, 14033
    • CHU caen
  • Lille, France, 59000
    • CHU Lille
  • Paris, France
    • Hôpital Cochin (APHP)
  • Saint-Malo, France, 35400
    • CH St-Malo
  • Tours, France, 37044
    • Chu Tours

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: AH Telemonitoring; Self measurement of blood pressure

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Study Director: Thierry DENOLLE, MD, Hospital of Dinard

Publications and helpful links

General Publications

• Ashworth DC, Maule SP, Stewart F, Nathan HL, Shennan AH, Chappell LC. Setting and techniques for monitoring blood pressure during pregnancy. Cochrane Database Syst Rev. 2020 Jul 23;8(8):CD012739. doi: 10.1002/14651858.CD012739.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2022
• Primary Completion (Estimated): November 1, 2023
• Study Completion (Estimated): November 1, 2023

Study Registration Dates

• First Submitted: August 21, 2018
• First Submitted That Met QC Criteria: August 24, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Hypertension; Pregnancy; telemonitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Hypertension, Pregnancy-Induced
• Other Study ID Numbers: 35RC17_8837_FETH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No