Premom: Pregnancy Remote Monitoring

NCT03246737 | Completed

• 1 other identifier: 14/078U
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pregnancies, Cardiovascular Complications

Outcome Measures

Primary Outcomes (1)

• prenatal follow-up

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

  up to 9 months (delivery)

Secondary Outcomes (5)

• maternal hemodynamic outcomes

  Day of delivery

• birth weight

  Day of delivery

• birth length

  Day of delivery

• Apgar at 1' and 5'

  Day of delivery

• admission to Neonatal Intensive Care

  Day of delivery

Study Arms (1)

pregnant women

Other: monitoring

Interventions

monitoring OTHER

pregnant women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

pregnant women

You may qualify if:

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

You may not qualify if:

• congenital malformations of the fetus

Sponsors & Collaborators

• Hasselt University: lead
• Ziekenhuis Oost-Limburg: collaborator

Related Publications (2)

• Lanssens D, Vandenberk T, Storms V, Thijs I, Grieten L, Bamelis L, Gyselaers W, Tang E, Luyten P. Changes in Intrapersonal Factors of Participants in the Pregnancy Remote Monitoring Study Who Are at Risk for Pregnancy-Induced Hypertension: Descriptive Quantitative Study. J Med Internet Res. 2023 Sep 6;25:e42686. doi: 10.2196/42686.

  PMID: 37672324 DERIVED

• 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.

  PMID: 30985286 DERIVED

MeSH Terms

Conditions

Pregnancy Complications, Cardiovascular

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Cardiovascular Diseases

Study Officials

• Wilfried Gyselaers, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: August 11, 2017
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 11, 2017

Record last verified: 2017-08