Clinical trial NCT03648645: Hypertensive Pregnant Women Monitored by Teletransmitted Self-measurements of Blood Pressure
Official title: Hypertensive Pregnant Women Monitored by Teletransmitted Self-measurements of Blood Pressure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension in Pregnancy
Keywords: Pregnancy
Hypertension
telemonitoring
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Hypertension specific intervention
timeFrame: Through study completion, an average of 9 months
Secondary outcomes:
measure: Number of blood pressure measurements per day and per week
timeFrame: Through study completion, an average of 9 months
measure: Likert scale to assess patients' satisfaction
timeFrame: Through study completion, an average of 9 months
measure: Likert scale to assess medical staff's satisfaction
timeFrame: Through study completion, an average of 9 months
Other outcomes:
Locations:
city: Caen
country: France
facility: CHU Caen
city: Lille
country: France
facility: CHU Lille
city: Paris
country: France
facility: Hôpital Cochin (APHP)
city: Saint-Malo
country: France
facility: CH St-Malo
city: Tours
country: France
facility: CHU Tours
Study officials:
affiliation: Hospital of Dinard
name: Thierry DENOLLE, MD
role: STUDY_DIRECTOR
References:
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.