Maria Makrides1, Karen Best1, Lisa Yelland1, Andrew McPhee1, Shao Zhou1, Julie Quinlivan1, Jodie Dodd1, Elinor Atkinson1, Huda Safa1, Jacqueline van Dam1, Nisha Khot1, Gustaaf Dekker1, Monika Skubisz1, Amanda Anderson1, Beth Kean1, Anneka Bowman1, Carly McCallum1, Kara Cashman1, Robert Gibson1. 1. From the South Australian Health and Medical Research Institute (M.M., K.B., L.Y., A.M., M.S., A.A., B.K., A.B., C.M., R.G.), School of Medicine (M.M., K.B.), School of Public Health (L.Y., K.C.), and School of Agriculture, Food, and Wine (S.Z., R.G.), University of Adelaide, Neonatal Services (A.M.) and the Department of Obstetrics and Gynaecology (J. Dodd, M.S.), Women's and Children's Hospital, the Departments of Obstetrics and Gynaecology, Flinders Medical Centre (E.A.), and the Northern Adelaide Local Health Network (G.D.), Adelaide, SA, the Institute of Health Research, University of Notre Dame, Fremantle, WA (J.Q.), Mater Mothers' Hospital, Brisbane, QLD (H.S.), and Werribee Mercy Health, Melbourne, VIC (J. van Dam, N.K.) - all in Australia.
Abstract
BACKGROUND: Previous studies have suggested that maternal supplementation with n-3 long-chain polyunsaturated fatty acids may reduce the incidence of preterm delivery but may also prolong gestation beyond term; however, more data are needed regarding the role of n-3 long-chain polyunsaturated fatty acids in pregnancy. METHODS: We performed a multicenter, double-blind, randomized trial in which women who were pregnant with single or multiple fetuses were assigned to receive either fish-oil capsules that contained 900 mg of n-3 long-chain polyunsaturated fatty acids (n-3 group) or vegetable-oil capsules that contained trace n-3 long-chain polyunsaturated fatty acids (control group) daily, beginning before 20 weeks of gestation and continuing to 34 weeks of gestation or delivery, whichever occurred first. The primary outcome was early preterm delivery, defined as delivery before 34 completed weeks of gestation. Other pregnancy and neonatal outcomes were also assessed. RESULTS:A total of 5544 pregnancies in 5517 women were randomly assigned at six centers in Australia; 5486 pregnancies were included in the primary analysis. Early preterm delivery occurred in the case of 61 of 2734 pregnancies (2.2%) in the n-3 group and 55 of 2752 pregnancies (2.0%) in the control group; the between-group difference was not significant (adjusted relative risk, 1.13; 95% confidence interval [CI], 0.79 to 1.63; P = 0.50). There were no significant differences between the groups in the incidence of interventions in post-term (>41 weeks of gestation) deliveries, in adverse events, or in other pregnancy or neonatal outcomes, except that a higher percentage of infants born to women in the n-3 group than in the control group were very large for gestational age at birth (adjusted relative risk, 1.30; 95% CI, 1.02 to 1.65). Percentages of serious adverse events did not differ between the groups. Minor gastrointestinal disturbances were more commonly reported in the n-3 group than in the control group. CONCLUSIONS: Supplementation with n-3 long-chain polyunsaturated fatty acids from early pregnancy (<20 weeks of gestation) until 34 weeks of gestation did not result in a lower incidence of early preterm delivery or a higher incidence of interventions in post-term deliveries than control. (Funded by the Australian National Health and Medical Research Council and the Thyne Reid Foundation; ORIP Australian New Zealand Clinical Trials Registry number, ACTRN12613001142729.).
RCT Entities:
BACKGROUND: Previous studies have suggested that maternal supplementation with n-3 long-chain polyunsaturated fatty acids may reduce the incidence of preterm delivery but may also prolong gestation beyond term; however, more data are needed regarding the role of n-3 long-chain polyunsaturated fatty acids in pregnancy. METHODS: We performed a multicenter, double-blind, randomized trial in which women who were pregnant with single or multiple fetuses were assigned to receive either fish-oil capsules that contained 900 mg of n-3 long-chain polyunsaturated fatty acids (n-3 group) or vegetable-oil capsules that contained trace n-3 long-chain polyunsaturated fatty acids (control group) daily, beginning before 20 weeks of gestation and continuing to 34 weeks of gestation or delivery, whichever occurred first. The primary outcome was early preterm delivery, defined as delivery before 34 completed weeks of gestation. Other pregnancy and neonatal outcomes were also assessed. RESULTS: A total of 5544 pregnancies in 5517 women were randomly assigned at six centers in Australia; 5486 pregnancies were included in the primary analysis. Early preterm delivery occurred in the case of 61 of 2734 pregnancies (2.2%) in the n-3 group and 55 of 2752 pregnancies (2.0%) in the control group; the between-group difference was not significant (adjusted relative risk, 1.13; 95% confidence interval [CI], 0.79 to 1.63; P = 0.50). There were no significant differences between the groups in the incidence of interventions in post-term (>41 weeks of gestation) deliveries, in adverse events, or in other pregnancy or neonatal outcomes, except that a higher percentage of infants born to women in the n-3 group than in the control group were very large for gestational age at birth (adjusted relative risk, 1.30; 95% CI, 1.02 to 1.65). Percentages of serious adverse events did not differ between the groups. Minor gastrointestinal disturbances were more commonly reported in the n-3 group than in the control group. CONCLUSIONS: Supplementation with n-3 long-chain polyunsaturated fatty acids from early pregnancy (<20 weeks of gestation) until 34 weeks of gestation did not result in a lower incidence of early preterm delivery or a higher incidence of interventions in post-term deliveries than control. (Funded by the Australian National Health and Medical Research Council and the Thyne Reid Foundation; ORIP Australian New Zealand Clinical Trials Registry number, ACTRN12613001142729.).
Authors: Christopher E Ramsden; Maria Makrides; Zhi-Xin Yuan; Mark S Horowitz; Daisy Zamora; Lisa N Yelland; Karen Best; Jennifer Jensen; Ameer Y Taha; Robert A Gibson Journal: Prostaglandins Leukot Essent Fatty Acids Date: 2019-12-13 Impact factor: 3.015
Authors: Daniel T Robinson; Linda Van Horn; Lauren Balmert; Robert M Silver; Samuel Parry; David M Haas; Deborah A Wing; William A Grobman Journal: Curr Dev Nutr Date: 2021-05-08
Authors: Susan E Carlson; Byron J Gajewski; Christina J Valentine; Elizabeth H Kerling; Carl P Weiner; Michael Cackovic; Catalin S Buhimschi; Lynette K Rogers; Scott A Sands; Alexandra R Brown; Dinesh Pal Mudaranthakam; Sarah A Crawford; Emily A DeFranco Journal: EClinicalMedicine Date: 2021-05-17