Hypertension in Pregnancy
Conditions
Keywords
Pregnancy, Hypertension, telemonitoring
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.
Interventions
DEVICESelf 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.
Sponsors
Rennes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of blood pressure measurements per day and per week | 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) |
| Likert scale to assess medical staff's satisfaction | Through study completion, an average of 9 months | — |
Countries
France
Outcome results
None listed