Extrait

Main PHOENIX study Background and study aims Pre-eclampsia during pregnancy can be a very serious condition for both mother and baby. It can cause a sudden, rapid rise in blood pressure and cause seizures, strokes, multiple organ failure and on rare occasions, death. Babies whose mothers have pre-eclampsia tend to be smaller and more likely to be born prematurely or stillborn. The cause of pre-eclampsia is not known but it goes once a woman has given birth. The current guidelines state that women with pre-eclampsia should be hospitalized for careful monitoring and their labour induced once they reach 37 weeks of pregnancy. At 37 weeks of pregnancy, babies are generally considered to be fully developed (although most pregnancies go on to 40 weeks). Some doctors think, given that the complications of pre-eclampsia can be serious, that it would be better to induce labour before 37 weeks of pregnancy. The aim of this study is to find out whether inducing delivery earlier, when a woman is between 34 and 37 weeks of pregnancy, reduces the harm the condition can cause to the mother and baby despite the baby being born before they are considered to be fully developed. Who can participate? Women aged 18 or over who are between 34 and 37 weeks of pregnancy with confirmed pre-eclampsia but whose condition does not warrant immediate delivery. What does the study involve? Women are randomly allocated to either the Planned Delivery Group or the Expectant Management Group. At this point, women are given a questionnaire to complete which gathers information on their health before they give birth. Women allocated to the Planned Delivery Group are induced within 48 hours of being allocated to the group. Generally, women are given a hormone called prostaglandin as a vaginal gel/pessary to start their labour. If this does not work, other methods of inducing labour are tried following the hospital’'s standard procedures. Before delivery is induced, doctors may want to give a steroid injection to the mother to help her baby’'s lungs mature faster. Women allocated to the Expectant Management Group continue to be closely monitored in hospital until they reach 37 weeks of pregnancy. At this time (or shortly afterwards), their labour is induced in the same way as for women in the Planned Delivery Group. However, if their health or that of their baby worsens, they may be delivered before this time. After delivery, women and their babies are cared for according to the hospital’'s standard practice regardless of the group they were allocated to. Information is collected on the health of the mother and baby until they are discharged from hospital. Six months after giving birth, women are sent a similar questionnaire to the one they completed whilst in hospital but the questionnaire also captures information on the NHS services that they have used since they were discharged. The questionnaire is again sent when their child reaches 2 years of age based on their due date. At this time a questionnaire is also sent to assess the health of their child. What are the possible benefits and risks of participating? It is difficult to separate the risks from the benefits of taking part in the study because they may balance each other out. Women who are selected to be in the Planned Delivery Group may have their baby delivered up to 3 weeks (at 34 weeks of pregnancy) before they are usually fully developed (a baby is considered to be fully developed at 37 weeks but most pregnancies go on to 40 weeks). This may result in the baby having problems associated with being born early. However, letting the woman'’s pregnancy continue might harm them and their baby more. Women who are selected to be in the Expectant Management Group may become ill from the conditions associated with pre-eclampsia because their pregnancy is allowed to continue for longer. Also, their condition or that of their baby’s may suddenly worsen so that they have to be delivered quickly, which might be distressing. It is not yet known which of the two management strategies is the best and the aim of the study is to find this out. Where is the study run from? The study will be run initially from six hospitals with neonatal units to find out if the recruitment targets for the study can be met. It will then be opened up to approximately 34 more hospitals (40 in total). When is the study starting and how long is it expected to run for? April 2014 to August 2017 Who is funding the study? National Institute for Health Research (NIHR) (UK) Who is the main contact? 1. Prof. Andrew Shennan ([email protected]) 2. Prof. Lucy Chappell ([email protected]) PEACOCK (PHOENIX-2) sub-study Background and study aims The cause of pre-eclampsia is not known, and it is not possible to tell which patients will get it more seriously. Researchers think there may be not such a good connection between the placenta and the mother’s womb. Some studies have shown changes in the blood level of a substance made by the placenta called Placental Growth factor (PlGF). This may be a useful test to help doctors decide which women and their babies are more at risk of becoming unwell. The aim of this sub-study is to improve how women between 34 and 37 weeks of pregnancy are assessed, by measuring the level of PlGF in their blood. Who can participate? Women aged 18 or over who are between 34 and 37 weeks of pregnancy with confirmed pre-eclampsia, but whose condition does not warrant immediate delivery. What does the study involve? Participants are asked for a small blood sample, about two teaspoons (12ml), which is tested for PlGF. Then, up until the time the baby is born they are asked for an extra blood sample at the same time as blood is taken for their regular tests. Apart from collecting the additional blood samples, the participants’ treatment is not affected in any way. The results from these tests is not shared with participants or their doctors and so the care they receive is exactly the same as if they were not taking part. Information is collected about the participants and their babies’ health until they are both discharged from hospital. What are the possible benefits and risks of participating? Measuring PlGF may help doctors improve the care for women with pre-eclampsia in the future. There are no expected serious side effects to having the blood test and blood tests are part of normal clinical care. Where is the study run from? The study will be run initially from six hospitals with neonatal units to find out if the recruitment targets for the study can be met. It will then be opened up to approximately 34 more hospitals (40 in total). When is the study starting and how long is it expected to run for? February 2016 to April 2018 Who is funding the study? National Institute for Health Research (NIHR) (UK) Who is the main contact? Prof. Lucy Chappell [email protected] PHOEBE (PHOENIX-3) study Background and study aims Pre-eclampsia can be a serious condition for both mother and baby. Most women with pre-eclampsia make a full recovery and their babies are healthy. However, pre-eclampsia can cause a sudden, rapid rise in blood pressure and in severe cases can cause fits, strokes, multiple organ failure and very rarely, death. It may restrict the flow of blood to the baby, so babies whose mothers have pre-eclampsia tend to be smaller and are more likely to be born early. Some studies have suggested that in some women, the woman’s heart might have to work harder because of the pre-eclampsia. The aim of this sub-study is to find out how pre-eclampsia might have a long-term effect on a woman’s heart. This will be done by looking at signs in the blood that may show that the heart has been working harder during pregnancy, and by taking a scan of the heart about six months after the baby is born. Who can participate? Women aged 18 or over who are between 34 and 37 weeks of pregnancy with confirmed pre-eclampsia, but whose condition does not warrant immediate delivery. What does the study involve? Participants are asked for a small blood sample, about two teaspoons (12ml). Then up until the time the baby is born participants are asked for an additional blood sample at the same time as their regular routine blood tests. After they have given birth, they are again asked for a small blood sample. Apart from collecting the additional blood samples, taking part in this sub-study does not affect treatment in any way. Information about participants and their babies’ health is collected until they are both discharged from hospital. At the end of the study, the blood samples are tested for substances that show how the heart is working. The results from these tests are not shared with participants or their doctors and so the care you receive is exactly the same as if they were not taking part in the sub-study. About six months after the birth of the baby, participants are asked to return to hospital to have an ultrasound scan which takes moving and still pictures of the heart, called an echocardiogram. It involves putting some gel on their chest, similar to any ultrasound scan they had when they were pregnant. From these pictures, the person doing the scan can see how the heart is working. This test takes about 20-30 minutes. The echocardiogram is being done for research purposes and so a clinical report is not produced. At the same visit, participants are also asked to give a small blood sample, about two teaspoons. Travel expenses for this part of the study are paid in the form of a voucher. What are the possible benefits and risks of participating? The person doing the echocardiogram looks to see if the heart is working normally. In a very few people, about 8 in 1000 women, a problem with their heart is found when they have this test. If this happens participants are offered a referral for an appointment with a heart specialist. This is expected to be needed for about three women in this sub-study. There are no expected serious side effects to having the blood samples taken and wherever possible blood samples for this sub-study are taken at the same time as having blood tests taken as part of routine maternity care. Where is the study run from? The study will be run initially from six hospitals with neonatal units to find out if the recruitment targets for the study can be met. It will then be opened up to approximately 34 more hospitals (40 in total). When is the study starting and how long is it expected to run for? February 2016 to April 2018 Who is funding the study? National Institute for Health Research (NIHR) (UK) Who is the main contact? Dr Fergus McCarthy [email protected]

Critère d'inclusion

• Pre-eclampsia in women between 34+0 and 36+6 weeks of gestation

Liens

• ictrp
• isrctn