Supplementation with milk enriched with complex lipids during pregnancy: A double-blind randomized controlled trial.

BACKGROUND: Gangliosides are a class of sphingolipids that are present in the cell membranes of vertebrates. Gangliosides influence a broad range of cellular processes through effects on signal transduction, being found abundantly in the brain, and having a role in neurodevelopment. OBJECTIVE: We aimed to assess the effects of maternal daily consumption of ganglioside-enriched milk vs non-enriched milk and a non-supplemented group of pregnant women on maternal ganglioside levels and pregnancy outcomes. DESIGN: Double-blind parallel randomized controlled trial. METHODS: 1,500 women aged 20-40 years were recruited in Chongqing (China) between 11 and 14 weeks of a singleton pregnancy, and randomized into three groups: Control-received standard powdered milk formulation (≥4 mg gangliosides/day); Complex milk lipid-enhanced (CML-E) group-same formulation enriched with complex milk lipids (≥8 mg gangliosides/day) from milk fat globule membrane; Reference-received no milk. Serum ganglioside levels were measured in a randomly selected subsample of 250 women per group. RESULTS: CML-E milk was associated with marginally greater total gangliosides levels in maternal serum compared to Control (13.02 vs 12.69 µg/ml; p = 0.034) but not to Reference group. CML-E milk did not affect cord blood ganglioside levels. Among the 1500 women, CML-E milk consumption was associated with a lower rate of gestational diabetes mellitus than control milk [relative risk 0.80 (95% CI 0.64, 0.99)], but which was not different to the Reference group. CML-E milk supplementation had no other effects on maternal or newborn health. CONCLUSIONS: Maternal supplementation with milk fat globule membrane, as a source of gangliosides, was not associated with any adverse health outcomes, and did not increase serum gangliosides compared with the non-supplemented reference group. TRIAL REGISTRATION: Chinese Clinical Trial Register (ChiCTR-IOR-16007700). CLINICAL TRIAL REGISTRATION: ChiCTR-IOR-16007700; www.chictr.org.cn/showprojen.aspx?proj=12972.

The CLIMB (Complex Lipids In Mothers and Babies) study: protocol for a multicentre, three-group, parallel randomised controlled trial to investigate the effect of supplementation of complex lipids in pregnancy, on maternal ganglioside status and subsequent cognitive outcomes in the offspring.

INTRODUCTION: Complex lipids are important constituents of the central nervous system. Studies have shown that supplementation with complex milk lipids (CML) in pregnancy may increase the level of fetal gangliosides (GA), with the potential to improve cognitive outcomes. METHODS AND ANALYSIS: We aim to recruit approximately 1500 pregnant women in the first trimester (11-14 weeks) and randomise them into one of the three treatment groups: standard maternal milk formulation, CML-enhanced maternal milk formulation or no maternal milk intervention with standard pregnancy advice (ie, the standard care). Maternal lifestyle and demographic data will be collected throughout the pregnancy, as well as biological samples (eg, blood, hair, urine, buccal smear, cord blood, cord and placenta samples). Data from standard obstetric care recorded in hospital maternity notes (eg, ultrasound reports, results of oral glucose tolerance test and pregnancy outcome data) will also be extracted. Postnatal follow-up will be at 6 weeks and 12 months of age, at which point infant cognitive development will be assessed (Bayley Scales of Infant Development I). ETHICS AND DISSEMINATION: This project was approved by the Ethics Committee of Chongqing Medical University. Dissemination of findings will take the form of publications in peer-reviewed journals and presentations at national and international conferences. TRIAL REGISTRATION NUMBER: ChiCTR-IOR-16007700; Pre-results.

Progesterone and nifedipine for maintenance tocolysis after arrested preterm labor: A systematic review and meta-analysis of randomized controlled trial.

OBJECTIVE: No treatment is recommended for routine maintenance tocolysis after an arrested preterm birth. Our present study aimed to evaluate the effect of progesterone and nifedipine as maintenance tocolysis therapy after an arrested preterm birth. MATERIALS AND METHODS: For relevant studies, we systematically searched the literature in databases of PubMed, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library. Only randomized controlled trials were included. RESULTS: Nine trials were included in our review. Nifedipine and progesterone were used for maintenance tocolysis. Compared to placebo treatment or no treatment, maintenance tocolysis with progesterone could significantly prolong the delivery gestational weeks [standard mean difference (SMD) 1.64; 95% confidence interval (CI), 1.21, 2.07; p < 0.00001], reduce the proportion of patients with delivery before 37 weeks (risk ratio 0.63; 95% CI, 0.47, 0.83; p = 0.001), and increase the birth weight (SMD 317.71; 95% CI, 174.89, 460.53; p < 0.0001). However, no such benefits were observed after maintenance tocolysis with nifedipine. Both nifedipine and progesterone had no significant influences on the following outcomes: neonatal intensive care unit stay, proportion of neonatal intensive care unit admission, neonatal mortality, and incidence of respiratory distress syndrome. CONCLUSION: Our results with maintenance tocolysis with progesterone may be useful for patients who had an episode of threatened preterm labor successfully treated with acute tocolytic therapy.