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Hypertensive disorders of pregnancy (HDP) affect approximately 10% of
all pregnancies. The aetiology and pathophysiology of HDP are still largely
unknown and an ideal prevention and treatment strategy does not exist. Although
there has been progress in perinatal survival, largely due to developments
in care of small babies, HDP continue to be major contributors to maternal
and perinatal morbidity and mortality, especially in developing countries.
The systematic review of randomized controlled trials of calcium supplementation
provides promising evidence that calcium supplementation may be effective
in preventing HDP in women with low calcium intake. It is important
to obtain a reliable, definitive answer to this question for both clinical
and programmatic reasons.
The World Health Organization and its collaborating institutions in developing
countries propose a double-blind randomized controlled trial (RCT) to evaluate
the impact of calcium supplementation (1.5 g/d) started before the twentieth
week of pregnancy to nulliparous women with low calcium intake, on the incidence
of pre-eclampsia. The proposed trial will enrol approximately 8500
women in seven countries over a period of 18 months. The primary outcomes
are the incidence of pre-eclampsia (hypertension and proteinuria) for women
and preterm birth for newborns. The sample size calculation is based
on a reduction in the rate of pre-eclampsia from 4% in the placebo group
to 2.8% in the calcium- supplemented group (30% reduction).
The UNDP/UNFPA/WHO/World Bank Special Programme of Research,
Development and Research Training in Human Reproduction (HRP) of the
Department of Reproductive Health and Research (RHR) at WHO will coordinate
the study in collaboration with local institutions. If the effectiveness
of routine calcium supplementation in preventing pre-eclampsia
is confirmed, WHO will develop and circulate recommendations for incorporation
of this practice into routine antenatal care. Nutritional
strategies to reach the recommended calcium
intake from food sources will also be prepared and disseminated.
It is expected that if the research confirms effectiveness, implementation
of this low-cost intervention will contribute to the reduction of maternal
and perinatal severe morbidity and mortality due to HDP in developing countries.
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