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HOspital care versus TELemonitoring in high risk pregnancy: the HOTEL trial

HOspital care versus TELemonitoring in high risk pregnancy: the HOTEL trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28710
Enrollment
200
Registered
2016-09-19
Start date
2016-11-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

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 wirel

Sponsors

UMC Utrecht
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: • Maternal age 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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Contacts

Public ContactJ.F.M. (Hans) van den Heuvel

UMC utrecht , department of Obstetrics

hotelstudie@umcutrecht.nl0887577249

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)