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

Not Applicable

Active, not recruiting

• Conditions: Hypertension in Pregnancy
• Interventions: Device: Self measurement of blood pressure

• Registration Number: NCT03648645
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study First Submitted: 2018-08-21
• Study First Submitted QC: 2018-08-24
• Study First Posted: 2018-08-27
• Study Start: 2022-05-25
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-07-28
• Primary Completion: 2023-11-01
• Study Completion: 2023-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AH Telemonitoring	Self measurement of blood pressure	Self measurement of blood pressure

Primary Outcome Measures

Name	Time	Method
Hypertension specific intervention	Through study completion, an average of 9 months	Percentage of blood pressure measurements initially planned and actually performed during the course of the investigation

Secondary Outcome Measures

Name	Time	Method
Number of blood pressure measurements per day and per week	Through study completion, an average of 9 months
Likert scale to assess medical staff's satisfaction	Through study completion, an average of 9 months
Likert scale to assess patients' satisfaction	Through study completion, an average of 9 months	Evaluation of the patients' satisfaction regarding their medical care during pregnancy assessed by Likert scale : from 1 (Very dissatisfied) to 5 (Very satisfied)

Trial Locations

Locations (5)

CHU Lille; 🇫🇷 Lille, France

CHU Caen; 🇫🇷 Caen, France

CHU Tours; 🇫🇷 Tours, France

Hôpital Cochin (APHP); 🇫🇷 Paris, France

CH St-Malo; 🇫🇷 Saint-Malo, France