Nausea and vomiting in pregnancy (NVP) affects up to 85% of women in the first half of pregnancy. Symptoms usually start at 6-8 weeks and for many women subside by 20 weeks gestation. Symptoms are often mild but 30% of sufferers experience more severe symptoms requiring medical care. The most severe form, hyperemesis gravidarum (HG), affects around 1-3% of women. These women suffer from relentless vomiting, dehydration, nutrient deficiencies and weight loss. HG can result in long hospital stays, many treatments and, where interventions fail, termination of pregnancy. NVP is associated with emotional and psychological distress and has a profound impact on quality of life (QOL) affecting all aspects of a woman’s life. Many sufferers feel unsupported, suffer higher rates of depression, anxiety and stress and often feel dissatisfied with care.
In EMPOWER we are trying to determine whether, in addition to intravenous fluid re-hydration, which anti-sickness drug ondansetron or metoclopramide is more effective up to 10 days after starting the medication compared to placebo (dummy drug). We also want to know more about the possible side effects of each drug.
Additionally we will investigate the effect NVP/HG has on the quality of life, and the symptoms of anxiety, stress and depression of sufferers.
The cause of NVP/HG is still unclear and there is no cure - treatment focuses on relieving symptoms and preventing serious side effects. Many women with mild symptoms are able to self-manage the condition using lifestyle changes. Some also access alternative or 'over the counter' treatment (e.g. ginger, sea bands, vitamins). Most women with moderate/severe symptoms need hospital treatment such as intravenous (IV) fluids through a drip and anti-sickness drugs.
For more detailed information about nausea and vomiting in pregnancy and hyperemesis gravidarum please go to the pregnancy sickness support website (click for link) .
What will it involve?
EMPOWER is a specific type of randomised controlled trial involving anti-sickness medication. In the study women can be allocated to one of four treatment groups. These are:
· Metoclopramide + Placebo
· Ondansatron + Placebo
· Metoclopramide + Ondansatron
· Placebo + Placebo
The study is 'blinded', which means that the hospital staff, research staff and participants will not know which treatment group they are in. All participants will also receive IV fluid re-hydration and all the medical tests and care that they need - You can read more about taking part on the 'taking part' page
How long will the study last?
The study treatment will last for a total of ten days. Study drugs will initially be given intravenously via a drip for up to four days as required. Once participants are able to tolerate fluids without being sick, the same drugs will be given by tablet until the tenth day.
Follow up by the research team will take place at 48 hours after treatment starts, then at 5 days and the final follow up questionnaires will be completed at 10 days.
The EMPOWER study has been approved by the Newcastle and North Tyneside Research Ethics Committee and the Medicines in Healthcare Regulatory Authority (MHRA).
The study is funded by the National Institute for Health Research, Health Technology Assessment program, which is part of the NHS.