PHOENIX Study - Version 1
Research type
Research Study
Full title
Pre-eclampsia in Hospital: Early Induction or Expectant Management
IRAS ID
143871
Contact name
Andrew Shennan
Contact email
Sponsor organisation
King's College London
ISRCTN Number
ISRCTN01879376
Duration of Study in the UK
6 years, 0 months, 0 days
Research summary
Research Summary
Background: Pre-eclampsia affects approximately one in twenty-five pregnancies and is diagnosed when the mother develops high blood pressure and protein in her urine. The complications of this disorder are potentially very serious. They include fits for the mother and poor growth and even death for the baby. Timely delivery of the baby will prevent many of these complications, but can also increase the risk of short and longer term problems for the baby related to premature birth and immaturity. In women with pre-eclampsia at the end of pregnancy, bringing on labour has been shown to reduce the risk of problems to the mother without any detriment to the baby. The risks/benefits of routinely delivering the baby between the 34th and 37th week of pregnancy are less clear.
Methods/Design: Pregnant women with pre-eclampsia between 34 and 36 weeks of pregnancy who do not require immediate delivery will be allocated by a computer (by chance, like tossing a coin) to delivery (usually by induction of labour within 48 hours) or to 'expectant management', where they will be observed closely and only delivered if complications arise or she reaches 37 weeks of pregnancy. We shall determine if there are fewer complications in the mother with the policy of immediate delivery, and whether this strategy leads to fewer babies being admitted to the neonatal unit and fewer deaths in this group when compared to those babies born to women in the 'wait and watch' group. At 2 years old, the babies will be assessed for normal brain development using a questionnaire that the mother will fill in regarding their behaviour. We will also find out about parents' experiences and the cost to the NHS of looking after the mother and baby, all of which may be affected by the strategy adopted.
Summary of Results
Why did we do this trial?
We know that pre-eclampsia is a common condition and can cause serious illness in a pregnant woman or baby. It is unclear how we should best advise women about the timing of delivery if they develop the condition between 34 and 37 weeks of pregnancy. We wanted to compare planned early birth and usual clinical practice (that is, planning birth at 37 weeks of pregnancy, or sooner if needed for clinical reasons).What did we do?
Between September 2014 and December 2018, 901 women with pre-eclampsia between 34 and
37 weeks of pregnancy agreed to take part. Half of the women were randomised to planning the birth of their babies within 48 hours and half were randomised to watching and waiting. During the study we collected pregnancy and birth information and health outcomes for the mother and the baby for
2 years after birth.What did we find?
We found that planned early birth is better for these women, with fewer complications such as severely high blood pressure. We found that more babies in the planned birth group were admitted to the neonatal unit, mainly because they were premature, but they did not have more complications such as breathing problems and they did not stay longer in the unit than babies in the usual clinical practice group. At 2 years old, the babies in both groups had similar scores for development, with their average scores in the normal range.What does this mean for women with pre-eclampsia?
Women with pre-eclampsia and their doctors will be able to make better decisions about the timing of delivery. Because the number of complications was reduced, and there was no difference in complications for the baby (though more babies were admitted to the neonatal unit), women and their doctors may use this information to share decision-making around timing of delivery.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
13/SC/0645
Date of REC Opinion
19 Dec 2013
REC opinion
Favourable Opinion