A Randomized Trial of Prenatal n-3 Fatty Acid Supplementation and Preterm Delivery.

Adult Dietary Supplements Double-Blind Method Fatty Acids, Omega-3 / therapeutic use Female Fetal Macrosomia Gestational Age Humans Incidence Infant, Newborn Intention to Treat Analysis Plant Oils / therapeutic use Pregnancy Pregnancy Outcome Premature Birth / epidemiology Prenatal Care Treatment Failure

Journal

The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562

Informations de publication

Date de publication:
12 09 2019
Historique:
entrez: 12 9 2019
pubmed: 12 9 2019
medline: 21 9 2019
Statut: ppublish

Résumé

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. 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. 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. 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.).

Sections du résumé

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.).

Identifiants

DOI: 10.1056/NEJMoa1816832 PMID: 31509674
pubmed: 31509674
doi: 10.1056/NEJMoa1816832
doi:

Substances chimiques

Fatty Acids, Omega-3 0
Plant Oils 0

Banques de données

ANZCTR
['ACTRN12613001142729']

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1035-1045

Subventions

Organisme : National Health and Medical Research Council
ID : 1046207
Pays : International
Organisme : National Health and Medical Research Council
ID : 1050468
Pays : International
Organisme : National Health and Medical Research Council
ID : 1052388
Pays : International
Organisme : National Health and Medical Research Council
ID : 1061704
Pays : International

Commentaires et corrections

Type : CommentIn

Informations de copyright

Copyright © 2019 Massachusetts Medical Society.

Auteurs

Maria Makrides (M)

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.

Karen Best (K)

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.

Lisa Yelland (L)

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.

Andrew McPhee (A)

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.

Shao Zhou (S)

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.

Julie Quinlivan (J)

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.

Jodie Dodd (J)

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.

Elinor Atkinson (E)

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.

Huda Safa (H)

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.

Jacqueline van Dam (J)

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.

Nisha Khot (N)

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.

Gustaaf Dekker (G)

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.

Monika Skubisz (M)

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.

Amanda Anderson (A)

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.

Beth Kean (B)

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.

Anneka Bowman (A)

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.

Carly McCallum (C)

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.

Kara Cashman (K)

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.

Robert Gibson (R)

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.

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Classifications MeSH

questionsmedicales.fr › Personnes › Tranches d'âge › Adulte › A Randomized Trial of Prenatal n-3 Fatty Acid...
questionsmedicales.fr › Aliments et boissons › Aliments › Compléments alimentaires › A Randomized Trial of Prenatal n-3 Fatty Acid...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Méthode en double aveugle › A Randomized Trial of Prenatal n-3 Fatty Acid...
questionsmedicales.fr › Lipides › Huiles › Huiles de poisson › Acides gras omega-3 › A Randomized Trial of Prenatal n-3 Fatty Acid...
questionsmedicales.fr › États, signes et symptômes pathologiques › Signes et symptômes › Macrosomie foetale › A Randomized Trial of Prenatal n-3 Fatty Acid...
questionsmedicales.fr › Phénomènes physiologiques des appareils urinaire et reproducteur › Phénomènes physiologiques de la reproduction › Âge gestationnel › A Randomized Trial of Prenatal n-3 Fatty Acid...
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