Condition category
Pregnancy and Childbirth
Date applied
18/01/2010
Date assigned
18/05/2010
Last edited
02/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Henry Kitchener

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

PB-PG-0906-11232

Study information

Scientific title

A randomised controlled trial of the 'Hyperemesis Impact Symptom Score' for individualised assessment and management of symptoms of hyperemesis gravidarum

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

Bolton Research Ethics Committee, 28/01/2008, ref: 07/H1009/88

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/05/2008

Overall trial end date

30/04/2011

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

240

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

United Kingdom

Trial participating centre

University of Manchester
Manchester
M13 9WL
United Kingdom

Sponsor information

Organisation

Central Manchester University Hospitals NHS Foundation Trust (UK)

Sponsor details

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

Sponsor type

Government

Website

http://www.cmft.nhs.uk/

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26212603

Publication citations

Additional files

Editorial Notes

02/09/2016: Publication reference added.