MOTHER trial: Maternal and Offspring outcomes after Treatment of HyperEmesis by Refeeding

Rationale:

Hyperemesis gravidarum (HG), or intractable

vomiting during pregnancy, is the single most

frequent cause of hospital admission in early

pregnancy. HG has a major impact on maternal

quality of life and has repeatedly been associated

with poor pregnancy outcome such as low birth

weight. Currently, women with HG are admitted

to hospital for intravenous fluid replacement,

without receiving specific nutritional attention.

Nasogastric tube feeding is sometimes used as

last resort treatment . At present no randomised

trials on dietary or rehydration interventions have

been performed. Small observational studies

indicate that enteral tube feeding effectively may

have the ability to treat dehydration and

malnutrition and alleviate nausea and vomiting

symptoms

Objective:

We aim to evaluate the effectiveness of early

enteral tube feeding in addition to standard care

on nausea and vomiting symptoms and

pregnancy outcomes in HG patients

Study design:

The MOTHER trial is a multicentre open label

randomised controlled trial (www.studies-

obsgyn.nl/mother)



Study population:

Women ≥ 18 years and hospitalised for HG

between 5+0 and 19+6 weeks gestation are

eligible for participation

Intervention:

Participants will be randomly allocated to

standard care with intravenous rehydration or

early enteral tube feeding in addition to standard

care

Main study parameters:

The primary outcome will be neonatal birth

weight. Secondary outcomes will be the 24-hour

Pregnancy Unique Quantification of Emesis and

nausea score (PUQE-24), maternal weight gain,

dietary intake, duration of hospital stay, number

of readmissions, quality of life and side-effects.

Also gestational age at birth, placental weight,

umbilical cord plasma lipid concentration and

neonatal morbidity will be evaluated. Analysis will

be according to the intention to treat principle

We hypothesize that enteral tube feeding is a more effective treatment for HG symptoms than intravenous rehydration and improves pregnancy outcome.

Quality fo life will be measured at baseline with the following questionnaires:
Nausea and Vomiting of Pregnancy QoL (NVPQoL),
Hyperemesis Impact of Symptoms (HIS),
Hospital Anxiety and Depression Scale (HADS),
Symptoms Check List-90 (SCL-90),
Short Form-36 (SF-36),
European Quality of Life (EQ5D).
Patients fill in additional NVPQoL, HIS and HADS questionnaires 1 and 3 weeks after randomization.

Patients will record the PUQE (which consists of 3 questions), dietary intake and weight at weekly intervals until 20 weeks of gestation. If dietary intake has normalized from 15 weeks gestation onwards, this will no longer be recorded.

In addition they will complete questionnaires 6 weeks after delivery (SF-36, HADS, EQ5D) and 12 months after delivery (SF-36, HADS, EQ5D, SCL-90).

Early enteral tube feeding, continued until sufficient oral intake versus intravenous rehydration (care as usual) in patients admitted because of hyperemesis gravidarum.