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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AH Telemonitoring | Experimental | Self measurement of blood pressure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self measurement of blood pressure | Device | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thierry DENOLLE, MD | Hospital of Dinard | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Caen | Caen | 14033 | France | |||
| CHU Lille |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32748394 | Derived | 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. |
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014652 | Vascular Diseases |
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|
| Through study completion, an average of 9 months |
| Likert scale to assess medical staff's satisfaction | Through study completion, an average of 9 months |
| Lille |
| 59000 |
| France |
| Hôpital Cochin (APHP) | Paris | France |
| CH St-Malo | St-Malo | 35400 | France |
| CHU Tours | Tours | 37044 | France |
| D002318 | Cardiovascular Diseases |