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Clinical Trials/NCT03246737
NCT03246737
Completed
Not Applicable

Premom: Pregnancy Remote Monitoring

Hasselt University0 sites60 target enrollmentJanuary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancies, Cardiovascular Complications
Sponsor
Hasselt University
Enrollment
60
Primary Endpoint
prenatal follow-up
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Multiple cardiovascular adaptations happen during pregnancy. When gestational hypertensive disorders (GHD) occurs, these adaptations are abnormal. Approximately 5 - 8 % of all pregnant women develop GHD.

GHD is an pregnancy complication which is characterized by an elevated blood pressure (≥ 140/90 mm Hg) and sometimes the appearance of proteinuria (≥3 g/ 24 hours) after twenty weeks of pregnancy. When this remains uncured, GHD can have severe complications for both mother and child. For this reason, a close follow-up of women with a high risk for developing this condition is recommended. This to detect and threat GHD early.

Patients can be included when they are at least 10 weeks pregnant. Every pregnant women receives two devices to control daily here parameters in her home environment: a blood pressure monitor and an activity tracker. The women will be asked to perform two blood pressure measurements a day and to wear the activity tracker day and night. This data will be send by Bluetooth and Wi-Fi to the investigator in the hospital. Also will the women be asked to measure once a week her weight and send this to the hospital.

Name of the device Measurement Protocol Blood pressure monitor Blood pressure, heart rate Twice a day (morning and evening) Activity tracker Activity- and sleep pattern Day and night Weight scale (not remote) Weight Once a week (morning)

The investigator controls daily the incoming measurements and consults the responsible gyneacologist when events (= abnormal blood pressure or weight measurement) occurs. Depending on the decisions of the gyneacologist, following actions can be performed:

  • Further observations
  • Extra monitor
  • Adjustments to the medication scheme
  • Performing an 24 hours urine collection
  • Admission to the prenatal observation ward When results are missing, the investigator contacts the women to ask of this measurement is due to personal or technical causes.

The purpose of this study part is to detect early signs of PE.

When patients gave birth, the data about the delivery (duration of labour, complications, mode of delivery, date of delivery, complications, parameters of the mother, specialties) and the neonate (gestational age, date and hour of birth, Apgar score, birth weight, length, complications and admission to the neonatal intensive care) will be collected. These data will be compared to the data of women who were admitted to the hospital for GHD, but who doesn't receive remote monitoring devices.

Registry
clinicaltrials.gov
Start Date
January 2015
End Date
December 2015
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Hasselt University
Responsible Party
Principal Investigator
Principal Investigator

Wilfried Gyselaers

prof. dr.

Hasselt University

Eligibility Criteria

Inclusion Criteria

  • \> 10 weeks of gestation, in the possession of a Smartphone

Exclusion Criteria

  • congenital malformations of the fetus

Outcomes

Primary Outcomes

prenatal follow-up

Time Frame: up to 9 months (delivery)

total number of prenatal appointments, monitors, echo's, prenatal hospitalizations, hospitalizations until delivery

Secondary Outcomes

  • Apgar at 1' and 5'(Day of delivery)
  • maternal hemodynamic outcomes(Day of delivery)
  • birth weight(Day of delivery)
  • birth length(Day of delivery)
  • admission to Neonatal Intensive Care(Day of delivery)

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