Nausea and vomiting in early pregnancy are common. In many cases, symptoms are mild and self-limiting. In other cases however, severe intractable vomiting called hyperemesis gravidarum (HG) can lead to dehydration, electrolyte disturbances and significant weight loss and has repeatedly been associated with poor pregnancy outcome including low birth weight. Thereby we have overwhelming evidence that poor maternal nutrition in early pregnancy has permanent detrimental effects on offspring health, primarily in the cardiometabolic disease spectrum. HG has a major impact on maternal wellbeing and quality of life, and remains the largest single cause of hospital admission in early pregnancy. Hospitalization can be required for intravenous treatment of dehydration and electrolyte imbalance. Currently women who suffer from HG do not receive any particular nutritional attention, although nasogastric tube feeding is sometimes used as treatment of last resort. However, the etiology of HG is poorly understood and at present there is no evidence on the effectiveness and efficiency for any treatment.
In this prospective study we aim to find out whether an early refeeding strategy can improve maternal and neonatal outcome, and reduce hospital stay.
Multi center randomized controlled trial
Patients 18 years of age or older will be eligible if they have been admitted to hospital because of HG at a gestational age between 5+0 and 19+6 weeks. A diagnosis of HG is made if excessive nausea or vomiting necessitates hospital admission.
· Gestational age between 5+0 and 19+6 weeks
· Informed consent
· Women with singleton or multiple pregnancy
· Hospital admission because of HG
· First admission or readmission for HG.
· Maternal age < 18 years
· Mola hydatidosa pregnancy
· Non-vital pregnancy
· Acute infection causing vomiting (e.g. acute appendicitis, pyelonephritis)
· Contra-indication for enteral tube feeding (including oesophageal varices, allergies to compounds in enteral tube mix)
· HIV infection
Early enteral tube feeding in addition to standard care versus intravenous rehydration (standard care).
The primary maternal outcome is the Pregnancy Unique Quantification of Emesis and nausea (PUQE) score one week after randomization. The primary neonatal outcome is birth weight. Secondary outcomes will be maternal quality of life, duration of hospital stay and readmission rates, maternal weightgain, ketonuria, neonatal morbidity, small for gestational age (SGA), prematurity, costs, side effects of treatment and molecular outcomes in umbilical cord blood and placental tissue that relate to HG.
The analysis will be by intention to treat. Based on a reduction in PUQE score of 2 points (maximum 15 points, SD 3 points) after tube feeding, a difference in birth weight >200gr (SD 400gr), and a possible loss to follow-up of 10%, we need a total of 120 participants (alpha error 5%, beta error 20%). The analysis will be performed by intention to treat, and stratified for center. Quality of life as well as symptoms scores will be analyzed using repeated measures analysis of variance.
We will collect data to estimate costs and cost-effectiveness, since the intervention will be more costly but might reduce hospital stay.
Total study time is 45 months. Preparation time 6 months, recruitment and data collection 36 months, analysis and report 3 months.
Dr T.J. Roseboom, AMC Amsterdam
Dr T.J. Roseboom, AMC Amsterdam
Dr B.W.J. Mol, AMC Amsterdam
Dr J.A.M. van der Post, AMC Amsterdam
Dr. C. Ris-Stalpers, AMC Amsterdam
Dr. R.C. Painter, AMC Amsterdam
Drs. I.J. Grooten, AMC Amsterdam
Foreest Medical School, MCA Alkmaar
Researcher contact details
Drs. I.J. Grooten, MD, PhD student AMC Amsterdam
T: +316 2297 1381 / 020 56 68483
E: email@example.com / firstname.lastname@example.org