No registrations found.
ID
Source
Brief title
Health condition
- preeclampsia
- premature rupture of membranes
- intra uterine growth restriction (IUGR)
- high risk pregnancy
- telemedicine
- preeclampsie
- prematuur gebroken vliezen
- intrauteriene groeirestrictie
- ehealth
- foetale bewaking
Sponsors and support
Intervention
Outcome measures
Primary outcome
patient safety; composite of perinatal outcome is defined as perinatal mortality, a 5-minute Apgar score below 7 and/or an arterial pH below 7,05, maternal morbidity (such as eclampsia, HELLP syndrome, tromboembolic events), NICU admission of the newborn and emergency caesarean section
Secondary outcome
Patient satisfaction, quality of life and cost effectiveness will be assessed using validated questionnaires and one self developed survey to look for preferences for the new strategy will be developed
Background summary
In this study we aim to study the effects of self-management at home in combination with telemedicine in high-risk pregnancies on safety, cost-effective and patient satisfaction. Pregnancies complicates with mild preeclampsia, intrauterine growth restriction, preterm rupture of membranes, recurrent reduced fetal movements, fetal anomalies requiring daily monitoring (e.g. gastroschisis) or fetal demise in obstetric history will be eligible for the study.
In this study we will train the use of the system to high-risk pregnant women teaching them how to handle the equipment. We expect that this facilitates the use of telemedicine at home irrespective of intelligence, technical skills, language barriers and socio-economic background.
In this study the following specific objectives will be addressed:
1) to determine whether this novel obstetric care strategy is as safe as the currently provided care during hospital admission;
2) to evaluate the feasibility and cost-effectiveness of telemedicine in high-risk pregnant women remaining at home;
3) to evaluate patient experience and satisfaction with a user-friendly surveillance system at home compared to currently provided hospital care for the same indication
Study objective
Self-management at home in combination with telemedicine in high-risk pregnancies is non-inferior compared to hospital admission regarding safety, cost-effectiveness and patient satisfaction.
Study design
inclusion 18 months
Intervention
Randomisation will take place between traditional hospital admittance or telemonitoring for daily monitoring of maternal and fetal parameters. In telemonitoring pregnant women will make use of a wireless cardiotocograph registration device and home blood pressure monitor and will have daily telephone calls with an obstetric health care professional in the hospital. Weekly outpatient visits will be planned for real-time contact and ultrasound assessment, blood sampling or urinary analysis if necessary.
J.F.M. (Hans) van den Heuvel
Utrecht
The Netherlands
0887577249
hotelstudie@umcutrecht.nl
J.F.M. (Hans) van den Heuvel
Utrecht
The Netherlands
0887577249
hotelstudie@umcutrecht.nl
Inclusion criteria
Necessity for hospital admittance for maternal or fetal surveillance because of one of the six following indications: intrauterine growth retardation, preeclampsia, preterm premature rupture of membranes, recurrent reduced fetal movements, fetal anomalies requiring daily monitoring (e.g. gastroschisis) or fetal demise in obstetric history
Exclusion criteria
• Maternal age <18 years
• Pregnancy complications requiring intravenous therapeutics or obstetric intervention within 48 hours
• Blood pressure >160/110 mmHg
• Antepartum haemorrhage or signs of placental abruption
• CTG registration with abnormalities indicating fetal distress or hypoxia
• Multiple pregnancies
• Place of residence 30 minutes driving away from a hospital
• Insufficient knowledge of Dutch or English language or impossibility to understand the training or instructions of the devices
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL5888 |
NTR-old | NTR6076 |
CCMO | NL55884.041.16 |
OMON | NL-OMON47643 |