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  1. 1
    Peer Reviewed

    A Simplified Regimen Compared with WHO Guidelines Decreases Antenatal Calcium Supplement Intake for Prevention of Preeclampsia in a Cluster-Randomized Noninferiority Trial in Rural Kenya.

    Omotayo MO; Dickin KL; Pelletier DL; Mwanga EO; Kung'u JK; Stoltzfus RJ

    Journal of Nutrition. 2017 Oct; 147(10):1986-1991.

    Background: To prevent preeclampsia, the WHO recommends antenatal calcium supplementation in populations with inadequate habitual intake. The WHO recommends 1500-2000 mg Ca/d with iron-folic acid (IFA) taken separately, a complex pill-taking regimen. Objective: The objective of this study was to test the hypothesis that simpler regimens with lower daily dosages would lead to higher adherence and similar supplement intake.Methods: In the Micronutrient Initiative Calcium Supplementation study, we compared the mean daily supplement intake associated with 2 dosing regimens with the use of a parallel, cluster-randomized noninferiority trial implemented in 16 primary health care facilities in rural Kenya. The standard regimen was 3 x 500 mg Ca/d in 3 pill-taking events, and the low-dose regimen was 2 x 500 mg Ca/d in 2 pill-taking events; both regimens included a 200 IU cholecalciferol and calcium pill and a separate IFA pill. We enrolled 990 pregnant women between 16 and 30 wk of gestation. The primary outcome was supplemental calcium intake measured by pill counts 4 and 8 wk after recruitment. We carried out intention-to-treat analyses with the use of mixed-effect models, with regimen as the fixed effect and health care facilities as a random effect, by using a noninferiority margin of 125 mg Ca/d.Results: Women in facilities assigned to the standard regimen consumed a mean of 1198 mg Ca/d, whereas those assigned to the low-dose regimen consumed 810 mg Ca/d. The difference in intake was 388 mg Ca/d (95% CI = 341, 434 mg Ca/d), exceeding the prespecified margin of 125 mg Ca/d. The overall adherence rate was 80% and did not differ between study arms.Conclusions: Contrary to our expectation, a simpler, lower-dose regimen led to significantly lower supplement intake than the regimen recommended by the WHO. Further studies are needed to precisely characterize the dose-response relation of calcium supplementation and preeclampsia risk and to examine cost effectiveness of lower and simpler regimens in program settings. This trial was registered at as NCT02238704. (c) 2017 American Society for Nutrition.
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  2. 2

    Managing complications in pregnancy and childbirth (MCPC): A guide for midwives and doctors. Highlights from the World Health Organization’s 2017 Second Edition.

    World Health Organization [WHO]. Department of Maternal, Newborn, Child and Adolescent Health; World Health Organization [WHO]. Department of Reproductive Health and Research; Maternal and Child Survival Program

    [Geneva, Switzerland], WHO, 2017 May. 8 p. (WHO/MCA/17.02; USAID Cooperative Agreement No. AID-OAA-A-14-00028)

    Since it was first published in 2000, the World Health Organization’s (WHO’s) Managing Complications in Pregnancy and Childbirth (MCPC) manual has been used widely around the world to guide the care of women and newborns who have complications during pregnancy, childbirth and the immediate postnatal period. The MCPC manual targets midwives and doctors working in district-level hospitals. Selected chapters from the first edition of the MCPC were revised in 2016 based on new WHO recommendations, and the second edition of the MCPC manual is now available. This brief reviews the revision process and summarizes updated clinical guidelines for a subset of revised chapters, including: emotional and psychological support; hypertensive disorders of pregnancy; bleeding in early pregnancy and after childbirth; and prevention and management of infection in pregnancy and childbirth. (Excerpt)
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  3. 3

    OS032. Pharmacotherapy for pre-eclampsia in low and middle income countries: An analysis of essential medicines lists (EMLS).

    Lalani S; Firoz T; Magee LA; Lowe R; Sawchuck D; Payne B; Gordon R; Vidler M; Dadelszen Pv And Community Level

    Pregnancy Hypertension. 2012 Jul; 2(3):193-4.

    INTRODUCTION: Pre-eclampsia is the second leading cause of maternal mortality in low and middle income countries (LMIC). Pharmacological management of pre-eclampsia has five major components including antihypertensive therapy for severe and non-severe hypertension, magnesium sulphate for prevention or treatment of eclampsia, treatment of pre-eclampsia-related end-organ complications, antenatal corticosteroids for acceleration of fetal pulmonary maturity given iatrogenic preterm delivery for maternal and/or fetal indications, and labour induction for such indicated deliveries. Essential medicines are defined by the World Health Organization (WHO) as "drugs that satisfy the health care needs of the majority of the population". Essential Medicines Lists (EMLs) detail these essential medicines within an individual country and support the argument that the medication should be routinely available. OBJECTIVES: To determine how many drugs required for comprehensive pre-eclampsia management are listed in national EMLs of LMIC. METHODS: We conducted a descriptive analysis of relevant drug prevalence on identified EMLs. We searched for the national EMLs of the 144 LMIC identified by the World Bank. EMLs were collected by broad based internet searches and in collaboration with the WHO. The EMLs were surveyed for therapies for the different aspects of pre-eclampsia management: hypertension (non-severe and severe with oral or parenteral agents), eclampsia, pre-eclampsia complications (e.g., pulmonary oedema, thrombosis), preterm birth, and labour induction. RESULTS: EMLs were located and reviewed for 58(40.3%) of LMIC. One or more parenteral antihypertensive agents were listed in 51(87.9%) EMLs. The most common agents were: hydralazine (67.2%), verapamil (58.6%), propranolol (39.7%) and sodium nitroprusside (37.9%); parenteral labetalol was listed by only 19.0% of EMLs. The most prevalent oral antihypertensive therapies listed were: nifedipine (96.6%, usually 10 or 20mg intermediate-acting tablets), methyldopa (94.8%), propranolol (89.7%), and atenolol (87.9%). Captopril, enalapril, hydrochlorothiazide and spironolactone were commonly listed. Magnesium sulphate for prevention and management of eclampsia was present in 86.2% of EMLs (and its antidote, calcium gluconate in 82.8%). To manage complications of pre-eclampsia, oral frusemide was listed in 94.8% of EMLs and parenteral heparin in 91.4%. Most EMLs listed parenteral dexamethasone (91.4%) for acceleration of fetal pulmonary maturity and oxytocin (98.3%) or a prostanoid (usually misoprostol, 39.7%) for labour induction. CONCLUSION: EMLs of LMIC provide comprehensive coverage of all aspects of recommended pre-eclampsia pharmacotherapy. These EMLs may be used as advocacy tools to ensure the availability of these therapies within each country. Copyright (c) 2012. Published by Elsevier B.V.
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  4. 4
    Peer Reviewed

    The World Health Organization Multicountry Survey on Maternal and Newborn Health project at a glance: the power of collaboration.

    Souza JP; WHO Multicountry Survey on Maternal and Newborn Health Research Network

    BJOG: An International Journal of Obstetrics and Gynaecology. 2014 Mar; 121 Suppl 1:v-viii.

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  5. 5

    Guideline: Calcium supplementation in pregnant women.

    World Health Organization [WHO]

    Geneva, Switzerland, WHO, 2013. [35] p.

    This guideline provides global, evidence-informed recommendations on the use of calcium supplements as a public health intervention for the purpose of improving pregnancy outcomes. Poor maternal and newborn health and nutrition remain significant contributors to the burden of disease and mortality. Calcium supplementation has the potential to reduce adverse gestational outcomes, in particular, by decreasing the risk of developing hypertensive disorders during pregnancy, which are associated with a significant number of maternal deaths and considerable risk of preterm birth, the leading cause of early neonatal and infant mortality. Member States have requested guidance from the World Health Organization (WHO) on the efficacy and safety of calcium supplementation in pregnant women as a public health strategy, in support of their efforts to achieve the Millennium Development Goals and the global targets set in the maternal, infant and child nutrition comprehensive implementation plan. The guideline is intended for a wide audience including policy-makers, their expert advisers, and technical and programme staff at organizations involved in the design, implementation and scaling-up of nutrition actions for public health.
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  6. 6
    Peer Reviewed

    Preeclampsia, gestational hypertension and intrauterine growth restriction, related or independent conditions?

    Villar J; Carroli G; Wojdyla D; Abalos E; Giordano D

    American Journal of Obstetrics and Gynecology. 2006 Apr; 194(4):921-931.

    Preeclampsia, gestational hypertension, and unexplained intrauterine growth restriction may have similar determinants and consequences. In this study, we compared determinants and perinatal outcomes associated with these obstetric conditions. We analyzed 39,615 pregnancies (data from the WHO Antenatal Care Trial), of which 2.2% were complicated by preeclampsia, 7.0% by gestational hypertension, and 8.1% by unexplained intrauterine growth restriction (ie, not associated with maternal smoking, maternal under-nutrition, preeclampsia, gestational hypertension, or congenital malformations). We compared the risk factors associated with these groups. Fetal death, preterm delivery, and severe neonatal morbidity and mortality were the primary outcomes. Logistic regression analyses were adjusted for study site, socioeconomic status, and (if appropriate) birth weight and gestational age. Diabetes, renal or cardiac disease, previous preeclampsia, urinary tract infection, high maternal age, twin pregnancy, and obesity increased the risk of both hypertensive conditions. Previous large-for-age birth, reproductive tract surgery, antepartum hemorrhage and reproductive tract infection increased the risk for gestational hypertension only. Independent of maternal age, primiparity was a risk factor only for preeclampsia. Both preeclampsia and gestational hypertension were associated with increased risk for fetal death and severe neonatal morbidity and mortality. Mothers with preeclampsia compared with those with unexplained intrauterine growth restriction were more likely to have a history of diabetes, renal or cardiac disease, chronic hypertension, previous preeclampsia, body mass index more than 30 kg/cm2, urinary tract infection and extremes of maternal age. Conversely, unexplained intrauterine growth restriction was associated with higher risk of low birth weight in previous pregnancies, but not with previous preeclampsia. Both conditions increased the risk for perinatal outcomes independently but preeclampsia was associated with considerable higher risk. Preeclampsia and gestational hypertension shared many risk factors, although there are differences that need further evaluation. Both conditions significantly increased morbidity and mortality. Conversely, preeclampsia and unexplained intrauterine growth restriction, often assumed to be related to placental insufficiency, seem to be independent biologic entities. (author's)
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  7. 7
    Peer Reviewed

    World Health Organization randomized trial of calcium supplementation among low calcium intake pregnant women.

    Villar J; Abdel-Aleem H; Merialdi M; Mathai M; Ali MM

    American Journal of Obstetrics and Gynecology. 2006 Mar; 194(3):639-649.

    The purpose of this trial was to determine whether calcium supplementation of pregnant women with low calcium intake reduces preeclampsia and preterm delivery. Randomized placebo-controlled, double-blinded trial in nulliparous normotensive women from populations with dietary calcium !600 mg/d. Women who were recruited before gestational week 20 received supplements (1.5 g calcium/d or placebo) throughout pregnancy. Primary outcomes were preeclampsia and preterm delivery; secondary outcomes focused on severe morbidity and maternal and neonatal mortality rates. The groups comprised 8325 women who were assigned randomly. Both groups had similar gestational ages, demographic characteristics, and blood pressure levels at entry. Compliance were both 85% and follow-up losses (calcium, 3.4%; placebo, 3.7%). Calcium supplementation was associated with a non-statistically significant small reduction in preeclampsia (4.1% vs 4.5%) that was evident by 35 weeks of gestation (1.2% vs 2.8%; P = .04). Eclampsia (risk ratio, 0.68: 95% CI, 0.48-0.97) and severe gestational hypertension (risk ratio, 0.71; 95% CI, 0.61-0.82) were significantly lower in the calcium group. Overall, there was a reduction in the severe preeclamptic complications index (risk ratio, 0.76; 95% CI, 0.66-0.89; life-table analysis, log rank test; P = .04). The severe maternal morbidity and mortality index was also reduced in the supplementation group (risk ratio, 0.80; 95% CI, 0.70-0.91). Preterm delivery (the neonatal primary outcome) and early preterm delivery tended to be reduced among women who were %20 years of age (risk ratio, 0.82; 95% CI, 0.67-1.01; risk ratio, 0.64; 95% CI, 0.42-0.98, respectively). The neonatal mortality rate was lower (risk ratio, 0.70; 95% CI, 0.56-0.88) in the calcium group. A 1.5-g calcium/day supplement did not prevent preeclampsia but did reduce its severity, maternal morbidity, and neonatal mortality, albeit these were secondary outcomes. (author's)
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