hyperemesis gravidarum (HG) Nausea and vomiting in pregnancy (NVP)
Conditions
Interventions
Women will be randomly allocated to either enteral tube feeding in addition to
standard care or standard care (intravenous rehydration, with possibly
anti-emetics, vitamins)
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Gestational age between 5+0 and 19+6 weeks Informed consent Women with singleton or multiple pregnancy Hospital admission because of hyperemesis gravidarum (the diagnosis of HG is made if excessive nausea or vomiting necessitates admission) First admission or readmission for hyperemesis gravidarum
Exclusion criteria
Exclusion criteria: Maternal age
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Birth weight | — |
Secondary
| Measure | Time frame |
|---|---|
| Maternal outcome measures: PUQE score (Pregnancy Unique Quantification of Emesis and nausea) one week after randomization Questionnaires: HIS (Hyperemesis Impact of Symptoms questionnaire), NVPQoL (Nausea and Vomiting of Pregnancy Quality of Life questionnaire), EQ-5D (EuroQoL), HADS (Hospital Anxiety and Depression Scale), SF-36 (Short Form 36) Weight gain Dietary intake Urinary ketones Duration hospital stay Readmission Side-effects tube feeding and/or intravenous rehydration Neonatal outcome measures: Neonatal morbidity Gestational age at birth Prematurity SGA Placental weight Lipid spectrum cord blood Molecular outcome measures: Molecular outcomes (genetic, epigenetic, RNA and/or protein profiles) in umbilical cord blood and placental tissue that relate to cause and consequences of HG. | — |
Countries
Netherlands
Outcome results
None listed