Impact of nausea in pregnancy using technology (INPUT) study
Research type
Research Study
Full title
Impact of Nausea on Pregnancy Using Technology (INPUT) Study Monitoring the trajectory of symptom severity and quality of life in women suffering from nausea and vomiting in pregnancy using CheckWare software and the impact of feedback information and advice
IRAS ID
220465
Contact name
S.C. Robson
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 11 months, 28 days
Research summary
AIM: To assess whether a web based data collection system (CheckWare) can be used to gather research outcome data (symptom severity and quality of life in pregnant women suffering from nausea and vomiting, NVP) via web-based data entry on 3 occasions over a 7 day period, and subsequently to trigger patient-initiated changes in care where there is a deterioration in symptom severity.
BACKGROUND: Around 85% of women suffer from some degree of NVP. This can cause physical and emotional distress and reduced QoL. Care varies between hospitals; women have reported feeling unsupported, dissatisfied, anxious and depressed.
DESIGN: Women attending primary or secondary care with any level of NVP, who are less than 11 weeks pregnant, will be asked to participate. Clinical staff will confirm whether it is appropriate for the research team to speak to potential participants and a member of the research team will then explain the study and obtain consent from the patient.
The researcher will then access the CheckWare website using a tablet computer and enter the baseline information. They will then teach the participant how to access the website and complete the initial questionnaires. The participant will subsequently access the web site and complete the follow up questionnaires 3 and 7 days later. The inputted data will then be processed by the software and advice given according to pathway designed by health care professionals, (i.e. depending on whether the severity of symptoms got worse, stayed the same or improved).
Each participant will be followed up by a member of the local research team on day 8 to ascertain what feedback and advice was given by the CheckWare system, and whether or not the participant followed this.
The study will last 12 months and recruit 200 women during this time.
DISSEMINATION. The results will be published in scientific journals and at conferences.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
17/LO/0333
Date of REC Opinion
9 Mar 2017
REC opinion
Further Information Favourable Opinion