Clinical trial NCT03246737: Premom: Pregnancy Remote Monitoring
Official title: Premom: Pregnancy Remote Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancies, Cardiovascular Complications
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
First posted: 2017-08-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* congenital malformations of the fetus

Primary outcomes:
measure: prenatal follow-up
timeFrame: up to 9 months (delivery)
Secondary outcomes:
measure: maternal hemodynamic outcomes
timeFrame: Day of delivery
measure: birth weight
timeFrame: Day of delivery
measure: birth length
timeFrame: Day of delivery
measure: Apgar at 1' and 5'
timeFrame: Day of delivery
measure: admission to Neonatal Intensive Care
timeFrame: Day of delivery
Other outcomes:
Locations:
Study officials:
affiliation: Hasselt University
name: Wilfried Gyselaers, prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lanssens D, Vandenberk T, Lodewijckx J, Peeters T, Storms V, Thijs IM, Grieten L, Gyselaers W. Midwives', Obstetricians', and Recently Delivered Mothers' Perceptions of Remote Monitoring for Prenatal Care: Retrospective Survey. J Med Internet Res. 2019 Apr 15;21(4):e10887. doi: 10.2196/10887.