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CompletedNCT03246737PremomUpdated Aug 11, 2017

Premom: Pregnancy Remote Monitoring

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Pregnancies, Cardiovascular Complications
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In context

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

pregnant women

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • congenital malformations of the fetus
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • pregnant women

    Other: monitoring

Interventions

  • Othermonitoring
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What researchers measure

Primary outcomes

  1. prenatal follow-up

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

    Time frame: up to 9 months (delivery)

Secondary outcomes

  1. maternal hemodynamic outcomes

    occurrence of essential hypertension/gestational hypertension/pre-eclampsie/help

    Time frame: Day of delivery

  2. birth weight

    neonatal outcome

    Time frame: Day of delivery

  3. birth length

    neonatal outcome

    Time frame: Day of delivery

  4. Apgar at 1' and 5'

    neonatal outcome

    Time frame: Day of delivery

  5. admission to Neonatal Intensive Care

    neonatal outcome

    Time frame: Day of delivery

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 30985286 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03246737
Lead sponsor
Hasselt University
Collaborators
Ziekenhuis Oost-Limburg
Responsible party
Wilfried Gyselaers (prof. dr., Hasselt University) — Principal investigator
First posted
Aug 11, 2017
Start date
Jan 2015
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Aug 11, 2017

Study contacts

Wilfried Gyselaers, prof. dr.
principal investigator · Hasselt University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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