Hypertensive Pregnant Women Monitored by Teletransmitted Self-measurements of Blood Pressure (FETH)
Primary Purpose
Hypertension in Pregnancy
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Self measurement of blood pressure
Sponsored by
About this trial
This is an interventional prevention trial for Hypertension in Pregnancy focused on measuring Pregnancy, Hypertension, telemonitoring
Eligibility Criteria
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.
Sites / Locations
- CHU Caen
- CHU Lille
- Hôpital Cochin (APHP)
- CH St-Malo
- CHU Tours
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AH Telemonitoring
Arm Description
Self measurement of blood pressure
Outcomes
Primary Outcome Measures
Hypertension specific intervention
Percentage of blood pressure measurements initially planned and actually performed during the course of the investigation
Secondary Outcome Measures
Number of blood pressure measurements per day and per week
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)
Likert scale to assess medical staff's satisfaction
Full Information
NCT ID
NCT03648645
First Posted
August 21, 2018
Last Updated
July 27, 2023
Sponsor
Rennes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03648645
Brief Title
Hypertensive Pregnant Women Monitored by Teletransmitted Self-measurements of Blood Pressure
Acronym
FETH
Official Title
Hypertensive Pregnant Women Monitored by Teletransmitted Self-measurements of Blood Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy
Keywords
Pregnancy, Hypertension, telemonitoring
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AH Telemonitoring
Arm Type
Experimental
Arm Description
Self measurement of blood pressure
Intervention Type
Device
Intervention Name(s)
Self measurement of blood pressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hypertension specific intervention
Description
Percentage of blood pressure measurements initially planned and actually performed during the course of the investigation
Time Frame
Through study completion, an average of 9 months
Secondary Outcome Measure Information:
Title
Number of blood pressure measurements per day and per week
Time Frame
Through study completion, an average of 9 months
Title
Likert scale to assess patients' satisfaction
Description
Evaluation of the patients' satisfaction regarding their medical care during pregnancy assessed by Likert scale : from 1 (Very dissatisfied) to 5 (Very satisfied)
Time Frame
Through study completion, an average of 9 months
Title
Likert scale to assess medical staff's satisfaction
Time Frame
Through study completion, an average of 9 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry DENOLLE, MD
Organizational Affiliation
Hospital of Dinard
Official's Role
Study Director
Facility Information:
Facility Name
CHU Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHU Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hôpital Cochin (APHP)
City
Paris
Country
France
Facility Name
CH St-Malo
City
Saint-Malo
ZIP/Postal Code
35400
Country
France
Facility Name
CHU Tours
City
Tours
ZIP/Postal Code
37044
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32748394
Citation
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.
Results Reference
derived
Learn more about this trial
Hypertensive Pregnant Women Monitored by Teletransmitted Self-measurements of Blood Pressure
We'll reach out to this number within 24 hrs