Pregnancies, Cardiovascular Complications Clinical Trial
— PremomOfficial title:
Premom: Pregnancy Remote Monitoring
| Verified date | August 2017 |
| Source | Hasselt University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | 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:
- 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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - > 10 weeks of gestation, in the possession of a Smartphone Exclusion Criteria: - congenital malformations of the fetus |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hasselt University | Ziekenhuis Oost-Limburg |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | prenatal follow-up | total number of prenatal appointments, monitors, echo's, prenatal hospitalizations, hospitalizations until delivery | up to 9 months (delivery) | |
| Secondary | maternal hemodynamic outcomes | occurrence of essential hypertension/gestational hypertension/pre-eclampsie/help | Day of delivery | |
| Secondary | birth weight | neonatal outcome | Day of delivery | |
| Secondary | birth length | neonatal outcome | Day of delivery | |
| Secondary | Apgar at 1' and 5' | neonatal outcome | Day of delivery | |
| Secondary | admission to Neonatal Intensive Care | neonatal outcome | Day of delivery |