An observational study in Pregnancies, Cardiovascular Complications, sponsored by Hasselt University. Completed. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-11.
Sponsored by Hasselt University · Observational
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:
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.
Hasselt University is the lead sponsor of 195 studies on the registry; 30 are open to participants now.
Counted across the registry records on this site, refreshed daily.
pregnant women
Exclusion Criteria:
Other: monitoring
prenatal follow-up
total number of prenatal appointments, monitors, echo's, prenatal hospitalizations, hospitalizations until delivery
Time frame: up to 9 months (delivery)
maternal hemodynamic outcomes
occurrence of essential hypertension/gestational hypertension/pre-eclampsie/help
Time frame: Day of delivery
birth weight
neonatal outcome
Time frame: Day of delivery
birth length
neonatal outcome
Time frame: Day of delivery
Apgar at 1' and 5'
neonatal outcome
Time frame: Day of delivery
admission to Neonatal Intensive Care
neonatal outcome
Time frame: Day of delivery
No study locations are listed for this record.
Plan to share: Undecided
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Pregnancy Complications, Cardiovascular
Hasselt University