A randomized trial of prenatal n−3 fatty acid supplementation and preterm delivery

Maria Makrides, Karen Best, Lisa Yelland, Andrew McPhee, Shao Zhou, Julie Quinlivan, Jodie Dodd, Elinor Atkinson, Huda Safa, Jacqueline Van Dam, Nisha Khot, Gustaaf Dekker, Monika Skubisz, Amanda Anderson, Beth Kean, Anneka Bowman, Carly McCallum, Kara Cashman, Robert Gibson

Research output: Contribution to journalArticle

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.

LanguageEnglish
Pages1035-1045
Number of pages11
JournalNew England Journal of Medicine
Volume381
Issue number11
DOIs
Publication statusPublished - 12 Sep 2019

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Makrides, Maria ; Best, Karen ; Yelland, Lisa ; McPhee, Andrew ; Zhou, Shao ; Quinlivan, Julie ; Dodd, Jodie ; Atkinson, Elinor ; Safa, Huda ; Van Dam, Jacqueline ; Khot, Nisha ; Dekker, Gustaaf ; Skubisz, Monika ; Anderson, Amanda ; Kean, Beth ; Bowman, Anneka ; McCallum, Carly ; Cashman, Kara ; Gibson, Robert. / A randomized trial of prenatal n−3 fatty acid supplementation and preterm delivery. In: New England Journal of Medicine. 2019 ; Vol. 381, No. 11. pp. 1035-1045.
@article{eb09173d96be42af81094c1ed68b3dd8,
title = "A randomized trial of prenatal n−3 fatty acid supplementation and preterm delivery",
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.",
author = "Maria Makrides and Karen Best and Lisa Yelland and Andrew McPhee and Shao Zhou and Julie Quinlivan and Jodie Dodd and Elinor Atkinson and Huda Safa and {Van Dam}, Jacqueline and Nisha Khot and Gustaaf Dekker and Monika Skubisz and Amanda Anderson and Beth Kean and Anneka Bowman and Carly McCallum and Kara Cashman and Robert Gibson",
year = "2019",
month = "9",
day = "12",
doi = "10.1056/NEJMoa1816832",
language = "English",
volume = "381",
pages = "1035--1045",
journal = "New England Journal of Medicine",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "11",

}

Makrides, M, Best, K, Yelland, L, McPhee, A, Zhou, S, Quinlivan, J, Dodd, J, Atkinson, E, Safa, H, Van Dam, J, Khot, N, Dekker, G, Skubisz, M, Anderson, A, Kean, B, Bowman, A, McCallum, C, Cashman, K & Gibson, R 2019, 'A randomized trial of prenatal n−3 fatty acid supplementation and preterm delivery', New England Journal of Medicine, vol. 381, no. 11, pp. 1035-1045. https://doi.org/10.1056/NEJMoa1816832

A randomized trial of prenatal n−3 fatty acid supplementation and preterm delivery. / Makrides, Maria; Best, Karen; Yelland, Lisa; McPhee, Andrew; Zhou, Shao; Quinlivan, Julie; Dodd, Jodie; Atkinson, Elinor; Safa, Huda; Van Dam, Jacqueline; Khot, Nisha; Dekker, Gustaaf; Skubisz, Monika; Anderson, Amanda; Kean, Beth; Bowman, Anneka; McCallum, Carly; Cashman, Kara; Gibson, Robert.

In: New England Journal of Medicine, Vol. 381, No. 11, 12.09.2019, p. 1035-1045.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A randomized trial of prenatal n−3 fatty acid supplementation and preterm delivery

AU - Makrides, Maria

AU - Best, Karen

AU - Yelland, Lisa

AU - McPhee, Andrew

AU - Zhou, Shao

AU - Quinlivan, Julie

AU - Dodd, Jodie

AU - Atkinson, Elinor

AU - Safa, Huda

AU - Van Dam, Jacqueline

AU - Khot, Nisha

AU - Dekker, Gustaaf

AU - Skubisz, Monika

AU - Anderson, Amanda

AU - Kean, Beth

AU - Bowman, Anneka

AU - McCallum, Carly

AU - Cashman, Kara

AU - Gibson, Robert

PY - 2019/9/12

Y1 - 2019/9/12

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85072145678&partnerID=8YFLogxK

U2 - 10.1056/NEJMoa1816832

DO - 10.1056/NEJMoa1816832

M3 - Article

VL - 381

SP - 1035

EP - 1045

JO - New England Journal of Medicine

T2 - New England Journal of Medicine

JF - New England Journal of Medicine

SN - 0028-4793

IS - 11

ER -