Skip to main content
Clinical Trials/NCT03648645
NCT03648645
Active, not recruiting
Not Applicable

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

Rennes University Hospital5 sites in 1 country50 target enrollmentMay 25, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension in Pregnancy
Sponsor
Rennes University Hospital
Enrollment
50
Locations
5
Primary Endpoint
Hypertension specific intervention
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 25, 2022
End Date
November 1, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Rennes University Hospital
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Hypertension specific intervention

Time Frame: 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 Outcomes

  • 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)

Study Sites (5)

Loading locations...

Similar Trials