INSPIRE
Research type
Research Study
Full title
A prospective*, randomised, Interventional Study evaluating the short-term PredIction of Pre-eclampsia / Eclampsia in pregnant women with suspected pre-eclampsia
IRAS ID
165863
Contact name
Manu Vatish
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Research Summary:
Preeclampsia (PE) is a disease of pregnancy which causes high blood pressure, protein in the urine and oedema. It causes the baby to be growth restricted. It is serious and can result in liver failure, kidney failure and seizures (fitting) in the mother whilst the baby is often delivered prematurely. PE occurs in 4% of all pregnancies and is caused by the placenta. Delivering the placenta cures the disease. Currently we do not have any method to determine who will get the disease and thus any patients with suspected PE are admitted to hospital, often for several days in order to make the diagnosis. We diagnose PE by excluding all the other possible causes of high blood pressure and protein in the urine. These tests include blood tests, examination of the urine and ultrasound scans of the baby. Over 50% of the patients admitted don't have PE, and this causes significant stress/anxiety for the mother and uses valuable resources from the NHS. There is a blood test which measures 2 placental factors (sFlt1 and PLGF) which are released into the mothers blood. This test, which has been developed by Roche Diagnostics (who are funding the study), has the potential to predict who will or will not get PE and this is the basis of this study. We propose to use this test to try to help us identify which patients will get PE and which patients will not get PE over the following week. We will recruit patients at presentation and, in addition to their routine bloods, ask for a research blood. The laboratory will perform the sFlt1/PLGF test and randomize the result to "reveal" or "non-reveal". All patients will be followed up, but we will use the "reveal" group to try and manage low risk women as outpatients.Summary of Results:
The ratio of maternal serum sFlt-1 (soluble fms-like tyrosine kinase 1) to PlGF (placental growth factor) has been used retrospectively to rule out the occurrence of preeclampsia, a pregnancy hypertensive disorder, within 7 days in women presenting with clinical suspicion of preeclampsia. A prospective, interventional, parallel-group, randomized clinical trial evaluated the use of sFlt-1/PlGF ratio in women presenting with suspected preeclampsia. Women were assigned to reveal (sFlt-1/PlGF result known to clinicians) or nonreveal (result unknown) arms. A ratio cutoff of 38 was used to define low (≤38) and elevated risk (>38) of developing the condition in the subsequent week. The primary end point was hospitalization within 24 hours of the test. Secondary end points were development of preeclampsia and other adverse maternal-fetal outcomes. We recruited 370 women (186 reveal versus 184 nonreveal). Preeclampsia occurred in 85 women (23%). The number of admissions was not significantly different between groups (n=48 nonreveal versus n=60 reveal; P=0.192). The reveal trial arm admitted 100% of the cases that developed preeclampsia within 7 days, whereas the nonreveal admitted 83% (P=0.038). Use of the test yielded a sensitivity of 100% (95% CI, 85.8–100) and a negative predictive value of 100% (95% CI, 97.1–100) compared with a sensitivity of 83.3 (95% CI, 58.6–96.4) and negative predictive value of 97.8 (95% CI, 93.7–99.5) with clinical practice alone. Use of the sFlt-1/PlGF ratio significantly improved clinical precision without changing the admission rate.REC name
South Central - Oxford B Research Ethics Committee
REC reference
15/SC/0126
Date of REC Opinion
31 Mar 2015
REC opinion
Further Information Favourable Opinion