HOspital care versus TELemonitoring in high risk pregnancy: the HOTEL trial
Completed
- Conditions
- - preeclampsia- premature rupture of membranes- intra uterine growth restriction (IUGR)- high risk pregnancy- telemedicine- preeclampsie- prematuur gebroken vliezen- intrauteriene groeirestrictie- ehealth- foetale bewaking
- Registration Number
- NL-OMON28710
- Lead Sponsor
- MC Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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