NUTRITIONAL INTERVENTIONS DURING PREGNANCY FOR THE PREVENTION OR TREATMENT OF MATERNAL MORBIDITY, MORTALITY OR PRETERM DELIVERY
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1 NUTRITIONAL INTERVENTIONS DURING PREGNANCY FOR THE PREVENTION OR TREATMENT OF MATERNAL MORBIDITY, MORTALITY OR PRETERM DELIVERY OVERVIEW OF RANDOMISED CONTROLLED TRIALS José Villar,, Mario Merialdi,, A Metin Gülmezoglu, Edgardo Abalos,, Guillermo Carroli,, Regina Kulier,, Mercedes de Onis
2 Epidemiological associations versus the impact of pragmatic interventions Timing of the insult / critical window / sensitive period Interpretation of the results of randomised controlled trials of maternal nutritional interventions Timing and location of nutrient deposition in the mother and the effect on fetal growth Duration and dose of nutritional supplementation Pharmacological effect versus nutritional effect Intervention specific outcomes versus mortality/birth weight outcomes
3 Percentage of placental and organ weight of the total weight at term by week of gestation
4 Absolute changes in skin-fold thickness during pregnancy and post partum
5 SELECTION CRITERIA Any systematic review or randomised controlled trial of a nutritional intervention during pregnancy
6 SYSTEMATIC REVIEWS OR TRIALS REPORTING ONE OF THE FOLLOWING OUTCOMES: Preterm delivery (<37 completed weeks) Pre-eclampsia, hypertension, infections, anaemia, haemorrhage, obstructed labour, duration of labour, caesarean section Maternal mortality
7 SYSTEMATIC REVIEWS/TRIALS EXCLUDED Interventions to stop labour Interventions to prolong pregnancy after preterm labour Interventions that were not exclusively nutritional (ANC packages, social support)
8 SEARCH STRATEGY Cochrane Database of Systematic Reviews up to issue 2, April 2002 (The Cochrane Library) For reviews not updated, the Cochrane Controlled Trials Register (CCTR) and Medline were searched up to July Trials identified were considered independently.
9 SEARCH STRATEGY Database of Abstracts of Reviews of Effectiveness (DARE) Electronic search of the CCTR for nutritional interventions which have not been reviewed Authors of the systematic reviews and trials
10
11 INCLUDED IN THE ANALYSES 15 systematic reviews 69 randomised trials included in the systematic reviews 14 randomised trials not included in systematic reviews: fish oil (4) zinc (5), vitamin A-beta carotene (4), vitamins E and C (1).
12 PRE-ECLAMPSIA Trials with outcome reported (trials in systematic review) Total women RR 95%CI Nutritional advice Balanced protein/energy Isocaloric balanced protein Energy/ protein restriction 1 (4) ( ) 3 (13) ( ) 1 (3) ( ) 2 (3) ( ) Salt restriction 2 (2) ( )
13 PREECLAMPSIA Trials with outcome reported (trials in systematic review) Total women RR 95%CI Calcium (low risk) Calcium (high risk) Calcium (adequate intake) Calcium (low intake) 6 (6) ( ) 5 (5) ( ) 4 (4) ( ) 6 (6) ( )
14 PRE-ECLAMPSIA Trials with outcome reported (trials in systematic review) Total women RR 95%CI Magnesium 2 (7) ( ) Fish Oil* 2 (2) ( ) Vitamins C and E 1 (-) ( ) * New trials have been published after the last update of the Cochrane review
15 NEW FISH OIL TRIALS: PRE-ECLAMPSIA Total women RR 95%CI Salvig 1996 Fish oil vs. no treatment * ( ) Onwude 1995 Fish oil vs. placebo ( ) Olsen 2000 (EARL-PIH trial) Fish oil vs. olive oil in women with previous PIH ( ) * Expt. = 0/266 Placebo = 1/131
16 ANAEMIA OR HAEMORRHAGE Trials with outcome reported (trials in systematic review) Total women RR 95%CI Iron 12 (20) ( ) Folate 6 (21) ( ) Iron and folate 6 (8) ( ) Magnesium 2 (7) ( ) Vitamin A 3 (5) ( )
17 RATE OF SEVERE POSTPARTUM ANAEMIA (HB< 90 G/L) WHO ANC TRIAL ARGENTINA New ANC Model % Women Standard ANC Model % Women Women supplemented Severe post partum anaemia
18 Percentage of women in the calcium and placebo groups in whom hemoglobin values were < 10g/dl or < 11g/dl
19 OBSTRUCTED LABOUR/CAESAREAN SECTION Trials with outcome reported (trials in systematic review) Total women RR 95%CI Salt 1 (2) ( ) restriction Iron (routine 1 (1) ( ) vs. selective) Iron (anemia 1 (2) ( ) treatment) Iron and folic 2 (8) ( ) acid Folate 2 (21) ( ) Zinc 3 (7) ( )
20 CAESAREAN SECTION AND MATERNAL HEIGHT Nulliparous women with ( ) or without ( ) perinatal distress.bjog 2001
21 VITAMIN A AND MATERNAL MORTALITY IN NEPAL (West et al, 1999) Cause Placebo (N=7241) Vitamin A (N= 7747) Beta carotene (N=7201) Obstetric ( ) 0.56 ( ) Infection ( ) 0.60 ( ) Injury ( ) Miscellaneous ( ) 0.38 ( ) Overall ( ) 0.51 ( )
22 PRETERM DELIVERY Trials with outcome reported (trials in systematic review) Total women RR 95%CI Nutritional 1 (4) ( ) advice Balanced 5 (13) ( ) protein/energy Isocaloric 1 (3) ( ) balanced protein Energy/protei 1 (3) ( ) n restriction High protein 1 (2) ( ) Salt restriction 1 (2) ( )
23 PRETERM DELIVERY Trials with outcome reported (trials in systematic review) Total women RR 95%CI Calcium 9 (11) ( ) Iron 1 (20) ( ) Folate 4 (21) ( ) Magnesium 5 (7) ( ) Fish oil* 2 (3) ( ) Zinc* 5 (7) ( ) * New trials have been published after the last update of the Cochrane review
24 NEW FISH OIL TRIALS: PRETERM DELIVERY Total Women RR 95%CI Bulstra- Ramakes 1994 Fish oil vs. placebo ( ) Onwude 1995 Fish oil vs. placebo ( ) Olsen 2000 (EARL-PD trial) Fish oil vs. olive oil in women with previous PTD ( )
25 NEW ZINC TRIALS: PRETERM DELIVERY INTERVENTION Total Women RR 95%CI Caulfield 1999 Zinc (15 mg/day) plus iron plus folate vs. iron plus folate ( ) Osendarp 2000 Merialdi 2001 Zinc (30 mg/day) vs. placebo Zinc (25 mg/day) plus iron plus folate vs. iron plus folate ( ) ( )
26 EFFECTIVENESS OF NUTRITIONAL INTERVENTIONS: PRE-ECLAMPSIA Practice Research Nutritional advice Balanced protein/energy Isocaloric balanced protein Energy/protein restriction Salt restriction needed needed needed needed needed
27 EFFECTIVENESS OF NUTRITIONAL INTERVENTIONS: PRE-ECLAMPSIA Practice Research Calcium Folate Iron and folate Magnesium Fish oil Possibly beneficial for women at high risk RR=0.21 ( ) and with low baseline intake RR= 0.32 ( ); RCT in progress needed needed needed Needed? data from low quality studies RR= 0.70 ( ) and heterogeneous results in new trials
28 EFFECTIVENESS OF NUTRITIONAL INTERVENTIONS: PRE-ECLAMPSIA Practice Research Zinc needed Vitamins C and E RCT in preparation (data from one RCT in high risk, non deficient women RR= ) Vitamin A No data needed Multinutrients Data not available yet RCT completed
29 EFFECTIVENESS OF NUTRITIONAL INTERVENTIONS: ANAEMIA OR HAEMORRHAGE Practice Research Iron and folate Magnesium Zinc Vitamin A Recommended Very effective intervention Need to complete a systematic review of daily vs. weekly supplementation Any future trial should include antepartum hemorrhage as primary outcome needed needed
30 EFFECTIVENESS OF NUTRITIONAL INTERVENTIONS: INFECTION Practice Research Zinc Vitamin A Vitamin A, beta carotene effective in reducing death due to infection needed New systematic review to be published soon. Update is needed before any new trial
31 EFFECTIVENESS OF NUTRITIONAL INTERVENTIONS: OBSTRUCTED LABOUR/CAESAREAN SECTION/DURATION OF LABOUR Practice Research Balanced protein/ energy Calcium Iron and folate Magnesium Zinc needed needed needed needed Any future randomized trial should include rate of caesarean section and/or duration of labour as an outcome
32 EFFECTIVENESS OF NUTRITIONAL INTERVENTIONS: PRETERM DELIVERY Practice Research Nutritional advice Balanced protein/energy Isocaloric balanced protein Energy/protein restriction Promising intervention needed needed needed
33 EFFECTIVENESS OF NUTRITIONAL INTERVENTIONS: PRETERM DELIVERY Practice Research High protein Salt restriction Calcium Iron Folate needed needed Stratified analysis in the new trail by risk level and age (teenagers) needed needed
34 EFFECTIVENESS OF NUTRITIONAL INTERVENTIONS: PRETERM DELIVERY Practice Research Iron and folate Magnesium Fish oil Zinc needed Needed Promising intervention Needed Promising intervention Needed Promising intervention
35 Pregnancy and Childbirth Trials in the Cochrane Library, 2000 N = 9014 % PPH Pre-eclampsia IUGR/SGA Pre-term delivery
36
37
38 NEW FISH OIL TRIALS: HYPERTENSION INTERVENTION Total Women RR 95%CI Salvig 1996 Fish oil vs. no treatment ( ) Bulstra- Ramakes 1994 Fish oil vs. placebo ( ) Onwude 1995 Fish oil vs. placebo ( ) Olsen 2000 (EARL-PIH trial) Fish oil vs. olive oil in women with previous PIH ( )
39 MATERNAL INFECTION Trials with outcome reported (trials in systematic review) Total women RR 95%CI Zinc 1 (7) ( )
40 OBSTRUCTED LABOUR/CAESAREAN SECTION Trials with outcome reported (trials in systematic review) Total women RR 95%CI Calcium (low risk) Calcium (high risk) Calcium (adequate intake) Calcium (low intake) 4 (6) ( ) 2 (5) ( ) 3 (4) ( ) 3 (6) ( )
41 DURATION OF LABOUR Trials with outcome reported (trials in systematic review) Total women Mean difference (hours) 95%CI Balanced energy/ protein 1 (6) ( ) Magnesium 1 (7) ( )
42 EFFECTIVENESS OF NUTRITIONAL INTERVENTIONS: HYPERTENSION Nutrient Practice Research Energy protein restriction Salt restriction Calcium Folate needed needed RCT in progress Possibly beneficial for women at high risk RR=0.45 ( ) and with low baseline intake RR= 0.49 ( ) needed
43 EFFECTIVENESS OF NUTRITIONAL INTERVENTIONS: HYPERTENSION Practice Research Iron and folate Fish oil Zinc Vitamins E and C Multinutrients Data not available yet needed needed needed needed (RCT in different populations) RCT completed
44 OVERVIEW Epidemiological associations versus impact of pragmatic interventions Timing of the insult and different fetal organ growth patterns Timing and location of nutrient deposition in the mother and fetal growth
45 OVERVIEW Duration and dose of supplementation Pharmacological versus nutritional effect Intervention specific outcomes versus overall mortality/birth weight outcomes Heterogeneity of outcomes and their causes
46 HYPERTENSION Trials with outcome reported (trials in systematic review) Total women RR 95%CI Energy/protei n restriction 3 (3) ( ) Salt restriction 2 (1) ( )
47 HYPERTENSION Trials with outcome reported (trials in systematic review) Total women RR 95%CI Calcium (low risk) Calcium (high risk) Calcium (adequate intake) Calcium (low intake) 6 (6) ( ) 5 (5) ( ) 4 (4) ( ) 6 (6) ( )
48 HYPERTENSION Trials with outcome reported (trials in systematic review) Total women RR 95%CI Iron and 2 (8) ( ) folate Folate 2 (21) ( ) Fish Oil* 2 (2) ( ) Zinc* 4 (7) ( ) Vitamins E and C 1 (-) ( )
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