Premom: Pregnancy Remote Monitoring

Study Overview
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Brief Summary
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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.

Official Title
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Premom: Pregnancy Remote Monitoring

Conditions
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Pregnancies, Cardiovascular Complications

Intervention / Treatment
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* Other: monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 10 weeks of gestation, in the possession of a Smartphone Exclusion Criteria: congenital malformations of the fetus

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pregnant women<br> | Other: monitoring<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prenatal follow-up | 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 | occurrence of essential hypertension/gestational hypertension/pre-eclampsie/help | Day of delivery | 
| birth weight | neonatal outcome | Day of delivery | 
| birth length | neonatal outcome | Day of delivery | 
| Apgar at 1' and 5' | neonatal outcome | Day of delivery | 
| admission to Neonatal Intensive Care | neonatal outcome | Day of delivery |