In this prospective study we aim to find out whether an early refeeding strategy in addition to standard care can improve maternal and neonatal outcome and reduce hospital stay.
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Birth weight
Secondary outcome
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.
Background summary
Hyperemesis gravidarum (HG) is the largest single cause of hospital admission
in early pregnancy. It has major impact on maternal wellbeing and quality of
life and has repeatedly been associated with poor pregnancy outcomes including
low birth weight.
Currently, women who suffer from HG and are admitted to the hospital will get
intravenous rehydration but do not get particular nutritional attention. While
enteral tube feeding effectively treats dehydration and malnutrition and we
have reason to believe that it alleviate HG symptoms, there is at present no
evidence on the effectiveness and efficiency for any treatment of HG.
Study objective
In this prospective study we aim to find out whether an early refeeding
strategy in addition to standard care can improve maternal and neonatal outcome
and reduce hospital stay.
Study design
Open label randomized clinical trial (RCT)
Intervention
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)
Study burden and risks
In women with HG, enteral tube feeding in addition to standard care may reduce
nausea and vomiting symptoms. It also may improve nutritional status, decrease
the duration of hospitalization and readmission and may have beneficial effects
on birthweight
On the other hand, enteral tube feeding in HG may have no effects or negative
effects on symptomology, duration of hospital stay or offspring health, in
which case the costs and discomfort make it a less attractive option as a
primary treatment.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
Maternal age < 18 years
Mola hydatidosa
Non-vital pregnancy
acute infection causing vomiting (acute appendicitis, pyelonephritis)
Contra indication for enteral tube feeding (including esophageal varices, allergies to compounds in enteral mix)
HIV infection
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL41011.018.12 |
| Other | NTR TC4197 |
| OMON | NL-OMON28457 |