CRADLE-4: Can Reduction of Adverse pregnancy outcomes occur with planned DeLivery vs.Expectant management in pre-eclampsia?

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Pre-eclampsia affects approximately one in twenty-five pregnancies and is diagnosed by doctors when the mother develops high blood pressure and protein in her urine. The complications of this disorder are potentially very serious. Pre-eclampsia, particularly when it occurs early on in pregnancy, can result in severe problems for the mother such as fits, bleeding, and may even result in her death. The baby can be affected by a poorly functioning placenta, which leads to reduced blood flow, inadequate nutrition and poor oxygen supply which can result in reduced growth so that the infant may be born with a low birthweight and may even die. Death of the baby is common when the disease is not recognized in a timely fashion, common in a LMIC setting. Timely delivery of the baby will prevent many of these complications, but can also increase the risk of problems for the baby related to premature birth and immaturity.In women who develop raised blood pressure or mild pre-eclampsia at the end of pregnancy, bringing on labour has been shown to reduce the risk of problems to the mother and also lower the caesarean section rate, without any increased risk to the baby. When pre-eclampsia occurs in early pregnancy, before the 34th week of pregnancy, the risk to the baby of being born early is high. In this case it is better not to deliver unless the mother or baby deteriorate. The risk/benefit of routinely delivering the baby between the 34th and 37th week of pregnancy is less clear. Approximately a third of women with pre-eclampsia present in this window, and the disease in more severe than at term. Delivery may prevent complications in the mother but might increase risks to the baby compared with delivery at term. This decision is even more complicated when women live in countries with less resources where there are fewer doctors, midwives, nurses, medical supplies and hospital beds and different cultural values. In this trial we would aim to determine whether recognition and accurate diagnosis with delivery (bringing on labour within 48 hours or caesarean) or 'watch and wait' management is better for women with pre-eclampsia living in India and Zambia between the 34th and 37th week of pregnancy and their babies. 'Watch and wait', which medical professionals call 'expectant management', means that pregnant women will be closely observed and only be delivered if any complications arise in either the mother or the baby, or if the 37th week of pregnancy is reached. To test this, pregnant women that have been diagnosed with pre-eclampsia using our CRADLE VSA device, who come into hospital or clinic between the 34th and 37th week of pregnancy but do not require immediate delivery, will be allocated by a computer (i.e. by chance, like tossing a coin) to delivery or expectant management. If they are allocated to delivery they may have to travel to a local hospital where they have the facilities for this. If they are allocated to expectant management they will continue to have the same care they would usually have had. This may include staying in hospital for observation or coming to clinic for regular check ups. We will find out if there are fewer complications in the mother if we adopt the policy of immediate delivery. The study will also find out if this strategy leads to fewer babies being admitted to hospital, less frequent admission to a baby intensive care unit and if there are fewer deaths in this group when compared to those babies born to women in the 'wait and watch' group.We have chosen to run this trial in India and Zambia as they have different health care systems and challenges. We will ensure we find out about how the strategy is affected in each country and about the experiences of women and their families so our results will be relevant to many other countries.