- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03246737
Premom: Pregnancy Remote Monitoring (Premom)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- > 10 weeks of gestation, in the possession of a Smartphone
Exclusion Criteria:
- congenital malformations of the fetus
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
pregnant women
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
prenatal follow-up
Time Frame: up to 9 months (delivery)
|
total number of prenatal appointments, monitors, echo's, prenatal hospitalizations, hospitalizations until delivery
|
up to 9 months (delivery)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
maternal hemodynamic outcomes
Time Frame: Day of delivery
|
occurrence of essential hypertension/gestational hypertension/pre-eclampsie/help
|
Day of delivery
|
birth weight
Time Frame: Day of delivery
|
neonatal outcome
|
Day of delivery
|
birth length
Time Frame: Day of delivery
|
neonatal outcome
|
Day of delivery
|
Apgar at 1' and 5'
Time Frame: Day of delivery
|
neonatal outcome
|
Day of delivery
|
admission to Neonatal Intensive Care
Time Frame: Day of delivery
|
neonatal outcome
|
Day of delivery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wilfried Gyselaers, prof. dr., Hasselt University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14/078U
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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