OBJECTIVE: To examine the effect of fish oil supplementation on duration of pregnancy, conditional on the woman's habitual fish intake. DESIGN: Multicentre 1:1 randomised clinical trial of effect of fish oil in a high-risk population of pregnant women in whom habitual fish intake was assessed at randomisation. SETTING: Nineteen university delivery wards in seven European countries. SUBJECTS: Pregnant women with preterm delivery, intrauterine growth retardation (IUGR), or pregnancy-induced hypertension (PIH) in a previous pregnancy (group 1, n=495); with twin pregnancies (group 2, n=367); or with suspicion of IUGR or threatening preeclampsia in the current pregnancy (group 3, n=106). Women were stratified into low, middle, or high fish consumers. METHODS: The intervention group received fish oil capsules providing 2.7 g long-chain n-3 fatty acids per day (n-3 poly unsaturated fatty acids (PUFA)) from around week 20 (groups 1 and 2) or 6.3 g n-3 PUFA from week 33 (group 3). The control regimen was capsules with olive oil. Effect on timing of spontaneous delivery was examined by Cox regression, assuming elective delivery (occurring in 40%) as a censoring event. Analyses of effect of fish oil were intention to treat, and all analyses were adjusted for maternal smoking, age, and parity. RESULTS: In group 1, fish oil reduced the hazard rate of spontaneous delivery (HR) by 44% (95% confidence interval 14-64%) and 39% (16-56%) in low and middle fish consumers, respectively, with no detectable effect (-56 to 33%) in high fish consumers. In groups 2 and 3, no significant effect of fish oil was detected in any of the sub-strata defined by baseline fish consumption. CONCLUSIONS: In pregnant women with previous pregnancy complications, fish oil supplementation delayed onset of delivery in low and middle, but not in high, fish consumers. SPONSORSHIP: March of Dimes Birth Defects Foundation, Concerted Action (ERB-BMH1-CT92-1906) and PECO (ERB-CIPD-CT94-0235) programmes of the European Commission, and the Danish National Research Foundation. Lube Ltd donated the oil capsules.
European Journal of Clinical Nutrition, 2007, Vol 61, Issue 8, p. 976-85