Pregnancy hypertension contributes 14% of deaths in pregnancy worldwide. This represents 60,000 maternal and perinatal deaths annually. The chance of dying from pre-eclampsia in the UK is now one in a million; whereas in a low resource country this is nearer 1 in 3000. These deaths are largely preventable with simple treatments such as anti-hypertensives, magnesium and the definitive treatment, delivery.
The World Health Organisation (WHO) recommends that all women with pre-eclampsia at 37 weeks’ gestation onwards are delivered. This 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, 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. Delivery is likely to prevent complications in the mother, as delivery cures pre-eclampsia, particularly in a LMIC setting where morbidity and mortality is high. It might benefit the baby by avoiding sudden risks from placental problems but it might increase the risks associated with being born early. This decision is even more complicated when women live in countries with limited resources where there are fewer doctors and nurses, medical supplies, hospital beds, neonatal support, and different cultural values.
In this trial, we aim to determine whether delivery within 48 hours (either through induction or Caesarean section) or ‘watch and wait’ (expectant) is better for women with pre-eclampsia and their babies. The trial will take place in India and Zambia in women between the 34th and 37th week of pregnancy. Expectant management involves close observation of women who will only be delivered if any complications arise in either the mother or the baby, or if the 37th week of pregnancy is reached. We plan to identify women in the community and randomly allocate whether they are delivered or have expectant management. An initial feasibility and acceptability phase will run for the initial 10 months of the trial.
India and Zambia have different health systems to one another and associated challenges, which will mean that the results are relevant to care of women with pre-eclampsia in various low and middle income country (LMIC) settings.
CRADLE 4 will be the first trial of its kind to be carried out in a low-income setting. By determining the optimal gestation for delivery in women with pre-eclampsia, this trial could impact on local, national and international guidelines relating to the care pathway of women in LMICs. This intervention, in conjunction with the CRADLE VSA, has the potential to significantly reduce the number of both maternal and neonatal deaths and improve access to care for women with pre-eclampsia.