Plain English Summary
Background and study aims
Preeclampsia (PE) is a medical condition which can develop during pregnancy, and can affect both the mother and unborn baby. The exact cause of PE is not known, however it is thought to happen because of a problem with the placenta. The placenta is a specialised organ which connects the mother’s blood supply to the baby’s, providing the baby with food (nutrients) and oxygen. In PE, it is thought that the blood supply to the placenta is reduced, which can mean the unborn baby does not get enough nutrients to develop properly. It is therefore very important that the signs of PE are spotted quickly so that the mother can be treated. The early signs of PE include high blood pressure (hypertension) and the presence of protein in the urine (proteinuria), however having these symptoms does not guarantee that a woman will develop it. Currently, there is no way of testing to find out who will develop the disease, and so patients with suspected PE are admitted to hospital, often for several days in order to make the diagnosis. Over 50% of the patients admitted don't have PE, which can be a great cause of stress and anxiety to the mother, and a waste of valuable resources in the NHS. sFlt-1 and PLGF are natural chemicals produced by the placenta and released into the mother’s blood. Recent studies have shown that in cases of PE, the amounts of these markers in the blood are different to normal. The aim of this study is to find out whether testing sFlt-1 and PLGF in the blood is a reliable way of predicting the chance of a woman developing PE.
Who can participate?
Adult women who are more than 24 weeks pregnant who are showing signs of PE.
What does the study involve?
Women who are showing signs of PE have a blood sample taken so that the amounts of sFlt-1 and PLGF in the blood can be measured. The women are then randomly allocated to one of two groups. For women in the first group, the result of the test is not revealed to the team looking after her, and she continues with the usual practice (being admitted to hospital and monitored). For women in the second group, the result of the test is given to the team looking after her so that they can make a decision about whether to admit her to hospital (based on the likelihood of her developing PE). If they feel that she has a low risk of developing PE, then she can be monitored as an outpatient. The accuracy of the test is then determined by seeing how many women develop PE and comparing them to the prediction from the test.
What are the possible benefits and risks of participating?
There are no direct benefits or risks of taking part in this study.
Where is the study run from?
Nuffield Department of Obstetrics and Gynaecology, Oxford (UK)
When is the study starting and how long is it expected to run for?
June 2015 to June 2016
Who is funding the study?
Roche Diagnostics Ltd (UK)
Who is the main contact?
Ms Georgina Longley
Trial website
Contact information
Type
Public
Primary contact
Ms Georgina Longley
ORCID ID
http://orcid.org/0000-0002-6012-2574
Contact details
Nuffield Department of Obstetrics and Gynaecology
University of Oxford
John Radcliffe Hospital
Headley Way
Headington
OX3 9DU
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
19292
Study information
Scientific title
A prospective, randomised INterventional Study evaluating the short-term PredIction of pReeclampsia/Eclampsia in pregnant women with suspected preeclampsia
Acronym
INSPIRE
Study hypothesis
The aim of this study is to investigate whether measuring 2 placental factors (sFlt1 and PLGF) in maternal blood has the potential to predict the likelihood of preeclampsia (PE), in order to determine whether the patient requires admission or can be sent home with outpatient follow up.
Ethics approval
South Central - Oxford B Research Ethics Committee, 31/03/2015, ref: 15/SC/0126
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Reproductive Health & Childbirth; Subtopic: Reproductive Health & Childbirth; Disease: Reproductive Health & Childbirth
Intervention
Patients attending the Maternity Assessment Unit, Day Assessment Unit, Antenatal Clinics and Delivery Suite/Labour Ward with suspected preeclampsia will be approached. Consenting participants who meet the inclusion criteria have a blood sample taken at the time of which will be tested for sFlt1/PLGF. At baseline, all participants undergo baseline assessments including taking their clinical history, blood pressure (serial), urinary protein analysis (dipstick or PCR), clinical examination, assessment offetal wellbeing (CTG) and growth (clinical or ultrasound depending on clinical judgement), as well as blood sampling. The patient’s sFlt1/PLGF test result will be randomized into the “Reveal” or “Non Reveal” groups.
"Not Reveal" group: The team looking after these patients will not be given the results of the sFlt1/PLGF analysis. Participants in this group are treated according to current practices for suspected cases of preeclampsia (PE). This involves admission to hospital, blood tests, serial blood pressure measurement, and urinary protein analysis together with CTG +/- Ultrasound.
"Reveal" group: The team looking after these patients are given the results of the sFlt1/PLGF analysis. They will then use this information to decide whether the patient requires admission in conjunction with the whole clinical picture.
All patients are then reviewed one week later, where clinical history, blood pressure (serial), urinary protein analysis
(dipstick or PCR), clinical examination, assessment of fetal wellbeing (CTG) and growth (clinical or ultrasound
depending on clinical judgement) will be performed. An repeat sFlt1/PLGF test (taken under the same "reveal" or "not reveal" conditions as above i.e. no change in randomization groups) will be performed in addition to routine blood tests. Admission rates and other clinical data outlined above will be collected for both reveal and non reveal groups.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Inpatient admission rate measured using electronic patient records (EPR) and case-note review at baseline, 1 week and time of delivery.
Secondary outcome measures
1. Incidence of preeclampsia is measured according to NICE guidelines at baseline, 1 week and time of delivery
2. Re-admission rate is measured using EPR at recruitment at baseline, 1 week and time of delivery
3. Birth weight is measured using EPR and casenotes at time of delivery
4. SCBU admission rate is measured using EPR at time of delivery
5. Foetal growth is measured using antenatal ultrasound scanning at baseline, 1 week and time of delivery
6. Total blood count and platelet count is measured using blood testing at baseline, 1 week and time of delivery
7. Renal and hepatic function is measured using blood testing at baseline, 1 week and time of delivery
Overall trial start date
11/06/2015
Overall trial end date
08/07/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Female aged between 18-45 years
2. Pregnant >24 weeks
3. Able to consent
4. Singleton pregnancy
5. New onset hypertension (Stratified as below – Management) AND/OR
6. New onset proteinuria AND/OR
7. New onset oedema/headache/visual Disturbance AND/OR
8. New onset hepatic/liver tenderness AND/OR epigastric pain AND/OR
9. Any other clinical suspicion of PE
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Planned Sample Size: 366; UK Sample Size: 366
Participant exclusion criteria
1. Unable to consent
2. Age less than 18 or over 45 at the time of recruitment
3. Unable to speak English well enough to understand the study information
4. Unwilling to participate
5. Preexisting preeclampsia
6. Multiple pregnancy or higher order pregnancy
7. Any significant disease or disorder which in the opinion of the investigator may either put the participants at risk or may influence the result of the study or the participant’s ability to participate in the study
Recruitment start date
11/06/2015
Recruitment end date
08/06/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Nuffield Department of Obstetrics and Gynaecology
University of Oxford
John Radcliffe Hospital
Headley Way
Headington
OX3 9DU
United Kingdom
Funders
Funder type
Industry
Funder name
Roche Diagnostics Ltd
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