Pregnancy related Acute hyperTension Intervention Action: a randomized trial comparing labetalol and nicardipine in women with acute hypertension in pregnancy (Platina-trial)

Approximately 10% of pregnancies are complicated by hypertensive disorders
(roughly 19 000 women yearly in The Netherlands). Approximately one third of
hypertensive disorders are severe and contribute substantially to maternal and
neonatal morbidity and mortality (iatrogenic preterm delivery).

RATIONALE: Evidence on which antihypertensive is most effective in treating
severe hypertensive disorders is lacking resulting in suboptimal care due to
lack of uniform policy and under-treatment.

OBJECTIVE: To compare, in women with acute severe hypertensive disorders,
clinical effectiveness of labetalol and nifedipine.

APPROACH: Randomized Controlled Trial with an economic analysis.


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INTERVENTIONS: Intravenous administration of labetalol iv vs. oral nifedipine

Hypertension in pregnancy occurs in 10% of pregnancies (roughly 190 000 women
per year in the Netherlands) and is usually mild in the majority of women.
However, about 1 in 3 of these women (60 000 women per year) develops severe
hypertension that puts them at high risk for maternal and neonatal morbidity
and mortality, and therefore justifies immediate treatment. Until women have
delivered their baby, with or without a period of intended prolongation of
pregnancy, adequate blood pressure control is of paramount importance.
There is consensus that women should receive antihypertensive drugs to lower
their blood pressure, but, in absence of clear evidence, it is unclear which
antihypertensive drug is preferred. The lack of evidence on this subject
reflects in considerable practice variation. As in other parts of the
world, in the Netherlands labetalol, nicardipine, nifedipine, ketanserin,
hydralazine and combinations of these medications are used. In view of the
potentially relevant differences for both mother and
neonate between these medications, there is an urgent need for insight in the
optimal treatment of women with severe hypertension in pregnancy. Such insight
will allow a rational standard leading to uniformity in treatment that could
improve patient safety and maternal and neonatal outcome and quality of life.
Uniform treatment of severe hypertension in pregnancy will result in
improvement of maternal and neonatal outcome with a reduction of admission to
maternal and neonatal intensive care. Although severe maternal complications,
including eclamptic seizures, cerebral hemorrhage, HELLP syndrome, liver
hematoma and rupture, pulmonary edema and maternal death are rare even in women
with hypertension, the high prevalence of hypertension in pregnancy itself,
makes that many young women and their neonates/children are affected, both in
the Netherlands and worldwide.
Evidence to support the choice of an antihypertensive is lacking. A Cochrane
review on the subject concluded, *until better evidence is available, the
choice of antihypertensive should depend on the clinician's experience and
familiarity with a particular drug, and on what is known about adverse
effects*. The current study will compare the clinical effectiveness, safety and
costs of two different most often used regimens in the Netherlands for
treatment of acute hypertension in pregnancy, i.e. intravenous labetalol and
intravenous nicardipine.