NCT03648645

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 27, 2018

Completed
3.7 years until next milestone

Study Start

First participant enrolled

May 25, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

1.4 years

First QC Date

August 21, 2018

Last Update Submit

July 27, 2023

Conditions

Hypertension in Pregnancy

Keywords

PregnancyHypertensiontelemonitoring

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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

  • Likert scale to assess medical staff's satisfaction

    Through study completion, an average of 9 months

Study Arms (1)

AH Telemonitoring

EXPERIMENTAL

Self measurement of blood pressure

Device: Self measurement of blood pressure

Interventions

Self measurement of blood pressureDEVICE

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.

AH Telemonitoring

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU Caen

Caen, 14033, France

Location

CHU Lille

Lille, 59000, France

Location

Hôpital Cochin (APHP)

Paris, France

Location

CH St-Malo

St-Malo, 35400, France

Location

CHU Tours

Tours, 37044, France

Location

Related Publications (1)

  • 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.

    PMID: 32748394DERIVED

MeSH Terms

Conditions

Hypertension, Pregnancy-InducedHypertension

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Thierry DENOLLE, MD

    Hospital of Dinard

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2018

First Posted

August 27, 2018

Study Start

May 25, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

July 28, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)