HOspital care versus TELemonitoring in high risk pregnancy: the HOTEL trial
- Conditions
- intrauterine growth retardationpreeclampsia10026908
- Registration Number
- NL-OMON47643
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 400
Necessity for hospital admittance for maternal or fetal surveillance because of one of the following: intrauterine growth retardation, preeclampsia, preterm premature rupture of membranes, recurrent reduced fetal movements, fetal anomaly (e.g. fetal gastroschisis) or prior perinatal demise in obstetric history.
• 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 the nearest hospital
• Insufficient knowledge of Dutch or English language or impossibility to understand the training or instructions of the devices
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>patient safety; composite of perinatal outcome is defined as perinatal<br /><br>mortality, a 5-minute Apgar score below 7 and/or an arterial pH below 7,05,<br /><br>maternal morbidity (such as eclampsia, HELLP syndrome, tromboembolic events),<br /><br>NICU admission of the newborn and emergency caesarean section. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Patient satisfaction, quality of life and cost effectiveness will be assessed<br /><br>using validated questionnaires and one self developed survey to look for<br /><br>preferences for the new strategy will be developed</p><br>
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.