Hyperemesis In Pregnancy (HIP) Trial: Inpatient versus outpatient management of severe nausea and vomiting in pregnancy

Plain English Summary

Background and study aims
Most women will experience some degree of nausea and vomiting during the early stages of pregnancy. This is sometimes referred to as ‘morning sickness’ and it usually resolves by around 20 weeks. Some experience a very severe form of nausea and vomiting which causes such dehydration that admission to hospital for fluid replacement via a drip is required. This condition is called hyperemesis gravidarum (HG). Women who experience HG often spend long periods of time in hospital. The condition is associated with a decrease in ability to perform household activities, decreased interaction with their children and increased time off work. Women with HG have significantly higher rates of depression and anxiety when compared to other pregnant women. Traditionally the treatment for HG involves admission to hospital for fluid and vitamin replacement through a drip together with anti-sickness medications. Many women find it very hard and distressing to be away from their families and normal activities of daily living. A few hospitals are now offering an ‘outpatient’ service for women suffering with HG. This means that women who would normally be admitted have their treatment over a shorter period of time then go home and return the next day to receive the same rehydration and anti-sickness therapy that they would have if they were admitted to the hospital. This continues on a daily basis until the woman’s condition has improved and she is discharged from the service. This form of management has advantages for the woman, allowing her to remain at home, and also economic benefits for the health service, reducing the number of admissions. Outpatient management of HG is not regularly available and it is not known if it is as effective in treating the condition as the traditional inpatient treatment. This study will directly compare the two forms of management to establish if there are any differences in their effectiveness.

Who can participate?
Women with a diagnosis of HG will be asked to participate in the study when they visit the hospital for the first time.

What does the study involve?
Participants will be randomly allocated to either being admitted and treated in the traditional way or receiving their treatment as an outpatient. The outpatient approach will mean they receive a more rapid form of rehydration therapy then go home and return the next day. The women will be followed closely and information gathered about their condition each day. A specific scoring system will be used to assess the level of sickness and vomiting. The aim of treatment is to reduce this score. Women will also be asked to complete eating, drinking and wellbeing scoring systems to assess their overall condition and these will be used to compare the two different treatments. The researchers will look at how long women need treatment for and how many of them re-attend the hospital after being discharged. The information gathered about women receiving both forms of treatment will be used to directly compare traditional inpatient management with outpatient treatment.

What are the possible benefits and risks of participating?
If outpatient management is found to be equally effective in managing women with HG it can be developed and recommended as best practice with social and economic benefits. The researchers are experienced clinical professionals working in the field of early pregnancy. They have designed and set up the outpatient management of HG service at Chelsea and Westminster Hospital, UK. There are no risks related to participation in this study.

Where is the study run from?
Chelsea and Westminster Hospital (UK)

When is the study starting and how long is it expected to run for?
The study started in March 2014. Recruitment is likely to continue for the next 2 and a half years.

Who is funding the study?
Chelsea and Westminster Hospital (UK)

Who is the main contact?
Miss Nicola Mitchell-Jones
nicola.mitchell-jones@chelwest.nhs.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

Chelsea and Westminster NHS Trust (UK)
Hospital/treatment centre

Research and Development Department
Unit 101, Harbour Yard, Chelsea Harbour
London
SW10 0XD
England
United Kingdom

"ROR"	https://ror.org/02gd18467

Funders

Funder type

Hospital/treatment centre

Results and Publications

Study outputs

Editorial Notes

15/02/2018: Publication reference added.
13/10/2017: IPD sharing statement added.
12/10/2017: Publication and dissemination plan added.