Symptom QUestionnaire to Ameliorate Symptoms of Hyperemesis (SQUASH) trial

ISRCTN	ISRCTN01121147
DOI	https://doi.org/10.1186/ISRCTN01121147
Secondary identifying numbers	PB-PG-0906-11232

Submission date: 18/01/2010
Registration date: 18/05/2010
Last edited: 02/09/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Prof Henry Kitchener
Scientific

Academic Unit of Obstetrics and Gynaecology
School of Cancer and Enabling Science
University of Manchester
St. Mary's Hospital, 5th Floor (Research)
Oxford Road
Manchester
M13 9WL
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A randomised controlled trial of the 'Hyperemesis Impact Symptom Score' for individualised assessment and management of symptoms of hyperemesis gravidarum
Study acronym	SQUASH
Study hypothesis	The medicalised model for dealing with hyperemesis gravidarum (HG) does not address all of the needs of women affected by the condition and that assessment with the 'Hyperemesis Impact Symptom Score' (HIS) questionnaire will result in more holistic and effective care.
Ethics approval(s)	Bolton Research Ethics Committee, 28/01/2008, ref: 07/H1009/88
Condition	Hyperemesis gravidarum
Intervention	Control group will receive standard care. Intervention group will be asked to complete the HIS questionnaire and treatment will be tailored to their needs as described in the HIS handbook, according to the response to the questionnaire. The intervention typically takes 30 - 60 minutes plus one telephone call at home and follow-up will be carried out at 2, 4 and 6 weeks after collection of baseline data. Those in the control arm are given standard care and follow up is carried out at 2, 4 and 6 weeks after collection of baseline data.
Intervention type	Other
Primary outcome measure	Quality of life at 2 weeks post-discharge as measured by the social functioning scale of the 36-item short form health survey (SF36) questionnaire.
Secondary outcome measures	1. Quality of life as measured by the SF36 (total and subscales) at 4 and 6 weeks following discharge 2. Nausea and vomiting as measured by the Pregnancy Unique Quantification of Emesis (PUQE) score 3. Cost effectiveness of implementing the questionnaire 4. Satisfaction with care as measured by the 8-item Client Satisfaction Questionnaire 5. Number of days spent in hospital with HG and number of admissions to hospital
Overall study start date	01/05/2008
Overall study end date	30/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	240
Participant inclusion criteria	1. Pregnant women 2. Admitted to participating hospitals with a diagnosis of HG 3. Aged 16 years and above 4. Able to give informed consent 5. HG is defined for this study as excessive vomiting in early pregnancy which results in hospital admission
Participant exclusion criteria	1. Onset of first symptoms beyond 14 weeks gestation 2. Previously diagnosed mental health problems 3. Diabetes
Recruitment start date	01/05/2008
Recruitment end date	30/04/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Manchester

Manchester
M13 9WL
United Kingdom

Sponsor information

Central Manchester University Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

R&D Directorate
Research and Innovation Directorate
1st Floor - Postgraduate Centre
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
England
United Kingdom

Website	http://www.cmft.nhs.uk/
"ROR"	https://ror.org/00he80998

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: PB-PG-0906-11232)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2015		Yes	No

Editorial Notes

02/09/2016: Publication reference added.