OBJECTIVE: To examine the effect of supplemental prenatal folic acid, folic acid-iron, folic acid-iron-zinc, and multiple micronutrients on maternal morbidity in rural Nepal. METHODS: A cluster-randomized double-masked controlled trial of pregnant women who received daily supplements from early pregnancy through 3 months post partum as per the treatment allocation. Women were interviewed at birth about labor and delivery complications and for 9 days post partum to obtain 24-hour histories of morbidity. RESULTS: A total of 3986 (97.3%) women completed an interview regarding labor and delivery; morbidity history was available for 3564 (87.0%) women. Folic acid-iron reduced the risk of postpartum hemorrhage (relative risk [RR] 0.59; 95% confidence interval [CI] 0.35-0.98). Risk of dysfunctional labor increased with multiple micronutrient supplementation (RR 1.28; 95% CI, 1.01-1.60), although preterm premature rupture of membrane decreased (RR 0.40; 95% CI, 0.21-0.79). Puerperal sepsis was lower in those receiving folic acid-iron, folic acid-iron-zinc, and multiple micronutrients compared with controls (P<0.05). CONCLUSION:Prenatal folic acid-iron supplementation reduced the risk of obstetric complications in this South Asian setting.
RCT Entities:
OBJECTIVE: To examine the effect of supplemental prenatal folic acid, folic acid-iron, folic acid-iron-zinc, and multiple micronutrients on maternal morbidity in rural Nepal. METHODS: A cluster-randomized double-masked controlled trial of pregnant women who received daily supplements from early pregnancy through 3 months post partum as per the treatment allocation. Women were interviewed at birth about labor and delivery complications and for 9 days post partum to obtain 24-hour histories of morbidity. RESULTS: A total of 3986 (97.3%) women completed an interview regarding labor and delivery; morbidity history was available for 3564 (87.0%) women. Folic acid-iron reduced the risk of postpartum hemorrhage (relative risk [RR] 0.59; 95% confidence interval [CI] 0.35-0.98). Risk of dysfunctional labor increased with multiple micronutrient supplementation (RR 1.28; 95% CI, 1.01-1.60), although preterm premature rupture of membrane decreased (RR 0.40; 95% CI, 0.21-0.79). Puerperal sepsis was lower in those receiving folic acid-iron, folic acid-iron-zinc, and multiple micronutrients compared with controls (P<0.05). CONCLUSION: Prenatal folic acid-iron supplementation reduced the risk of obstetric complications in this South Asian setting.