Symptom QUestionnaire to Ameliorate Symptoms of Hyperemesis (SQUASH) trial
| ISRCTN | ISRCTN01121147 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01121147 |
| Protocol serial number | PB-PG-0906-11232 |
| Sponsor | Central Manchester University Hospitals NHS Foundation Trust (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) programme (ref: 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
Plain English summary of protocol
Not provided at time of registration
Contact information
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) |
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. |
| Key secondary outcome measure(s) |
1. Quality of life as measured by the SF36 (total and subscales) at 4 and 6 weeks following discharge |
| Completion date | 30/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 240 |
| Key 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 |
| Key exclusion criteria | 1. Onset of first symptoms beyond 14 weeks gestation 2. Previously diagnosed mental health problems 3. Diabetes |
| Date of first enrolment | 01/05/2008 |
| Date of final enrolment | 30/04/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
M13 9WL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/09/2016: Publication reference added.
