Planned Delivery Better Than Expectant Management for Preterm Pre-Eclampsia

Becky McCall

June 25, 2019

LONDON - Significant adverse maternal outcomes were fewer in mothers with planned delivery between 34+0 and 36+6 weeks [34 weeks plus 0 days to 36 weeks plus 6 days] of pregnancy compared with expectant management, the largest trial to date in women with preterm pre-eclampsia shows.

However, there was a significant increase in neonatal unit (NNU) admissions for prematurity with planned delivery (which led to earlier deliveries overall), according to findings from the Pre-eclampsia in Hospital: Early Induction or Expectant Management (PHOENIX) study.

Active Question

Prof Lucy Chappell, National Institute of Health Research (NIHR) research professor in obstetrics at King's College, London, presented results of the study at the RCOG (Royal College of Obstetrics and Gynaecology) World Congress 2019. 

"This is an active question for women and the healthcare professionals looking after them, where they have to balance the benefits and risks of continuing pregnancy against proceeding immediately to delivery," said Prof Chappell. "This is similar in other pregnancy complications, such as foetal growth restriction, or preterm rupture of the membranes, and it is important that we tackle these challenges with good research."

Women with pre-eclampsia are at risk of morbidity or in severe cases, maternal or foetal death, explained Prof Chappell. Delivery after 37 weeks' gestation is routinely indicated and does not significantly increase operative morbidity in the mother. In contrast, the risk/benefit of delivery between 34+0 and 36+6 weeks gestation is unclear, as reduced risks to the mother and infant associated with pregnancy cessation, and therefore halting disease progression, must be balanced against risks of immaturity due to premature birth. Approximately 33% of all women who develop pre-eclampsia fall into this 34+0 and 36+6 week potential delivery category.

PHOENIX Trial

The 2010 NICE 'Guideline for Hypertension in Pregnancy' for pre-term pre-eclampsia recognises that there is a grey area for women with pre-eclampsia with mild to moderate hypertension between weeks 34 and 37 of pregnancy. Optimal timing of the birth is unclear.

In view of this, PHOENIX was designed to determine whether delivery between 34+0 and 36+6 weeks reduces maternal complications without short and long-term detriment to the infant, compared with expectant management and delivery at 37 weeks.

Pregnant women between 34+0 and 36+6 weeks of gestation, with pre-eclampsia, singleton or twin pregnancy were included. Maternal and perinatal outcomes were analysed.

In total, 901 patients were randomised to either planned delivery (n=450) or expectant management (n=451). Mean age was 30 years, 70% were white, and 57% were having their first birth. Women had normal blood pressure at booking.

The primary outcome for the mother was a composite measure of maternal morbidity and/or recorded systolic blood pressure of greater than or equal to 160 mmHg post-randomisation.

First Results Reported

Results were partially reported at the congress, with full results submitted to a journal. Planned delivery was found to lead to a reduction in maternal morbidity and/or the incidence of recorded systolic blood pressure of greater than or equal to 160 mmHg compared with expectant delivery. These results were statistically significant.

The perinatal primary outcome was a composite of perinatal death and NNU admissions up to hospital discharge. The planned delivery group had an increased risk of perinatal death compared with the expectant management group. Again, the result was statistically significant. NNU admissions also showed a statistically significant higher proportion in the planned delivery versus the expectant delivery group.

A higher proportion of women in the expectant management group had systolic blood pressure of greater than or equal to 160 mmHg post-randomisation than those in the planned group. Spontaneous vaginal delivery was higher in the planned delivery group. Premature delivery, as expected, was higher in the planned delivery compared with the expectant management group, at 42% vs. 25% respectively. There were similar numbers of serious adverse events in both groups.  

"This is the largest study [to date] in women with late preterm pre-eclampsia. We can use this new information to help counsel women with this disease, to enable shared decision-making about the advantages and disadvantages around timing of delivery for each individual woman," Prof Chappell remarked.

Different Hospitals, Different Levels of Care

After the presentation there was some audience discussion about the provision of NNU care were the recommendations to be followed.

One member of the audience, Dr Thomas Everett, consultant obstetrician and subspecialist in maternal-fetal medicine at Leeds Teaching Hospitals NHS Trust, spoke up after the presentation. "Are you being slightly hard on the clinicians here? Is this not a service set up where we have a neonatal unit in the majority of units and we often lack a transitional care arrangement. In the latter case, babies are forced into a neonatal unit and have that label attached to their care, whereas some hospitals have provision [transitional care] to care for babies that don’t need neonatal care but aren’t quite ready to go home with the mum?"

Prof Chappell agreed that this was often the case, noting that in the UK there were five possible levels of care, but not all levels were available in all hospitals. Sometimes there is a need for enhanced surveillance but not necessarily interventions, she explained. Different hospitals have different pressures and levels of back up, she agreed.

COI: Professor Chappell and Dr Everett have declared no relevant disclosures.

Presented at the RCOG World Congress 2019. Tuesday 18th June 2019.

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