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Preconception-initiated low-dose aspirin might positively affect pregnancy outcomes, but this possibility has not been adequately assessed. Our aim was to investigate whether low-dose aspirin improved livebirth rates in women with one to two previous pregnancy losses. In this multicentre, block-randomised, double-blind, placebo-controlled trial, women aged 18–40 years who were attempting to become pregnant were recruited from four medical centres in the USA. Participants were stratified by eligibility criteria—the original stratum was restricted to women with one loss at less than 20 weeks' gestation during the previous year, whereas the expanded stratum included women with one to two previous losses, with no restrictions on gestational age or time of loss. Women were block-randomised by centre and eligibility stratum in a 1:1 ratio. Preconception-initiated daily low-dose aspirin (81 mg per day) plus folic acid was compared with placebo plus folic acid for up to six menstrual cycles; for women who conceived, study treatment continued until 36 weeks' gestation. Participants, trial staff, and investigators were masked to the assigned treatment. The primary outcome was livebirth rate, which was analysed by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00467363. Overall, 1228 women were recruited and randomly assigned between June 15, 2007, and July 15, 2011, 1078 of whom completed the trial and were included in the analysis (535 in the low-dose aspirin group and 543 in the placebo group). 309 (58%) women in the low-dose aspirin group had livebirths, compared with 286 (53%) in the placebo group (p=0·0984; absolute difference in livebirth rate 5·09% [95% CI −0·84 to 11·02]). Pregnancy loss occurred in 68 (13%) women in the low-dose aspirin group, compared with 65 (12%) women in the placebo group (p=0·7812). In the original stratum, 151 (62%) of 242 women in the low-dose aspirin group had livebirths, compared with 133 (53%) of 250 in the placebo group (p=0·0446; absolute difference in livebirth rate 9·20% [0·51 to 17·89]). In the expanded stratum, 158 (54%) of 293 women in the low-dose aspirin group and 153 (52%) of 293 in the placebo group had livebirths (p=0·7406; absolute difference in livebirth rate 1·71% [−6·37 to 9·79]). Major adverse events were similar between treatment groups. Low-dose aspirin was associated with increased vaginal bleeding, but this adverse event was not associated with pregnancy loss. Preconception-initiated low-dose aspirin was not significantly associated with livebirth or pregnancy loss in women with one to two previous losses. However, higher livebirth rates were seen in women with a single documented loss at less than 20 weeks' gestation during the previous year. Low-dose aspirin is not recommended for the prevention of pregnancy loss. Eunice Kennedy Shriver National Institute of Child Health and Human Development (US National Institutes of Health).

Abstract Context Dyslipidemia is common, and resultant endothelial dysfunction may impact reproductive outcomes. No prospective study has examined the effect of preconception lipid parameters in both female and male partners or their interaction on live birth. Objective To determine whether live birth is associated with preconception lipids in both partners by planned fertility treatment. Design Secondary analysis of the Folic Acid and Zinc Supplementation Trial, conducted between June 2013 and December 2017. Couples were followed for 9 months after randomization and until delivery. Setting Multicenter study. Participants Couples seeking fertility treatment (n = 2370; females 18-45 years, males ≥18 years). Exposures Female, male, and couple abnormal vs normal preconception lipid concentrations [total cholesterol (TC), low-density lipoprotein (LDL), high-density lipoprotein, triglycerides]. Main Outcome Measures Live birth. Results Among 2370 couples, most males (84%) and females (76%) had at least 1 abnormal lipid parameter. Males planning in vitro fertilization (IVF, n = 373) with elevated LDL had lower probability of live birth than those with normal levels [47.4% vs 59.7%, adjusted relative risk (aRR) 0.79, 95% confidence interval (CI) 0.65-0.98]. In couples planning IVF where both partners had elevated TC or LDL, live birth was lower than those with normal levels (TC: 32.4% vs 58.0%, aRR 0.53, 95% CI 0.36-0.79; and LDL: 41.9% vs 63.8%, aRR 0.69, 95% CI 0.55-0.85). Lipid parameters were not associated with live birth for couples planning non-IVF treatments. Conclusion Couples planning IVF where both partners had elevated TC or LDL and males planning IVF with elevated LDL had decreased probability of live birth. These findings may support lipid screening in patients seeking fertility treatment for prognostic information for reproductive outcomes.

South Asia has >50% of the global burden of low birth weight (LBW). The objective was to determine the extent to which maternal nutrition interventions commenced before conception or in the 1st trimester improved fetal growth in this region. This was a secondary analysis of combined newborn anthropometric data for the South Asian sites (India and Pakistan) in the Women First Preconception Maternal Nutrition Trial. Participants were 972 newborn of mothers who were poor, rural, unselected on basis of nutritional status, and had been randomized to receive a daily lipid-based micronutrient supplement commencing ≥3 months prior to conception (Arm 1), in the 1st trimester (Arm 2), or not at all (Arm 3). An additional protein-energy supplement was provided if BMI <20 kg/m2 or gestational weight gain was less than guidelines. Gestational age was established in the 1st trimester and newborn anthropometry obtained <48-hours post-delivery. Mean differences at birth between Arm 1 vs. 3 were length +5.3mm and weight +89g. Effect sizes (ES) and relative risks (RR) with 95% CI for Arm 1 vs. 3 were: length-for-age Z-score (LAZ) +0.29 (0.11-0.46, p = 0.0011); weight-for-age Z-score (WAZ) +0.22 (0.07-0.37, p = 0.0043); weight-to-length-ratio-for-age Z-score (WLRAZ) +0.27 (0.06-0.48, p = 0.0133); LAZ<-2, 0.56 (0.38-0.82, p = 0.0032); WAZ <-2, 0.68 (0.53-0.88, p = 0.0028); WLRAZ <-2, 0.76 (0.64-0.89, p = 0.0011); small-for-gestational-age (SGA), 0.74 (0.66-0.83, p<0.0001); low birth weight 0.81 (0.66-1.00, p = 0.0461). For Arm 2 vs. 3, LAZ, 0.21 (0.04-0.38); WAZ <-2, 0.70 (0.53-0.92); and SGA, 0.88 (0.79-0.97) were only marginally different. ES or RR did not differ for preterm birth for either Arm 1 vs. 3 or 2 vs. 3. In conclusion, point estimates for both continuous and binary anthropometric outcomes were consistently more favorable when maternal nutrition supplements were commenced ≥3 months prior to conception indicating benefits to fetal growth of improving women's nutrition in this population.

Context:Inflammation is linked to causes of infertility. Low-dose aspirin (LDA) may improve reproductive success in women with chronic, low-grade inflammation.Objective:To investigate the effect of preconception-initiated LDA on pregnancy rate, pregnancy loss, live birth rate, and inflammation during pregnancy.Design:Stratified secondary analysis of a multicenter, block-randomized, double-blind, placebo-controlled trial.Setting:Four US academic medical centers, 2007 to 2012.Participants:Healthy women aged 18 to 40 years (N = 1228) with one to two prior pregnancy losses actively attempting to conceive.Intervention:Preconception-initiated, daily LDA (81 mg) or matching placebo taken up to six menstrual cycles attempting pregnancy and through 36 weeks’ gestation in women who conceived.Main Outcome Measures:Confirmed pregnancy, live birth, and pregnancy loss were compared between LDA and placebo, stratified by tertile of preconception, preintervention serum high-sensitivity C-reactive protein (hsCRP) (low, <0.70 mg/L; middle, 0.70 to <1.95 mg/L; high, ≥1.95 mg/L).Results:Live birth occurred in 55% of women overall. The lowest pregnancy and live birth rates occurred among the highest hsCRP tertile receiving placebo (44% live birth). LDA increased live birth among high-hsCRP women to 59% (relative risk, 1.35; 95% confidence interval, 1.08 to 1.67), similar to rates in the lower and mid-CRP tertiles. LDA did not affect clinical pregnancy or live birth in the low (live birth: 59% LDA, 54% placebo) or midlevel hsCRP tertiles (live birth: 59% LDA, 59% placebo).Conclusions:In women attempting conception with elevated hsCRP and prior pregnancy loss, LDA may increase clinical pregnancy and live birth rates compared with women without inflammation and reduce hsCRP elevation during pregnancy.Preconception-initiated low-dose aspirin improved pregnancy and live birth rates among women with low-grade inflammation prior to pregnancy.

Background Preconception care (PCC) is a series of biomedical, mental, and psycho-social health services provided to women and a couple before pregnancy and throughout subsequent pregnancies for desired outcomes. Millions of women and new-borns have died in low-income countries due to impediments that arise before and exaggerate during pregnancies that are not deal with as part of pre-conception care. To the best of our knowledge, however, there is a lack of information about preconception care practice and its determinants in southern Ethiopia, including the study area. This study was therefore planned to assess the practice of preconception care and its determinants among mothers who recently gave birth in Wolkite town, southern Ethiopia, in 2020. Methods A community-based cross-sectional study was conducted from February 1 to 30, 2020. A total of 600 mothers who have given birth in the last 12 months have been randomly selected. A two-stage sampling technique was employed. For data collection, a pre-tested, semi-structured questionnaire was used. The data was encoded and entered into Epi-Data version 3.1 and exported for analysis to SPSS version 23. Household wealth status was determined through the application of principal component analysis(PCA). The practice PCC was considered as a count variable and measured as a minimum score of 0 and a maximum of 10. A bivariable statistical analysis was performed through analysis of variance (ANOVA) and independent t-tests and variables with a p-value of < 0.05 were eligible for the generalized linear regression model. To see the weight of each explanatory variable on PCC utilization, generalized linear regression with a Poisson link was done. Results Of the sampled 600 participants, 591 took part in the study, which yielded a response rate of 98.8%.The mean (± SD) score of the practice of PCC was 3.94 (± 1.98) with minimum and maximum scores of 0 and 10 respectively. Only 6.4% (95%CI: 4.6, 8.6) of mothers received all selected items of PCC services. Thecommonest item received by 67.2% of mothers was Folic acid supplementation, while 16.1% of mothers received the least item of optimizing psychological health. Education status of mother[AOR 0.74, 95%CI 0.63, 0.97], time spent to access nearby health facilities [AOR 0.69, 95%CI 0.58, 0.83], availability of PCC unit [AOR 1.46; 95%CI 1.17, 1.67], mother’s knowledge on PCC [AOR 1.34, 95%CI 1.13, 1.65], being a model household [AOR 1.31, 95%CI 1.18, 1.52] and women’s autonomy in decision making [AOR 0.75, 95%CI 0.64, 0.96] were identified as significant predictors of practice of PCC. Conclusion The uptake of WHO-recommended PCC service elements in the current study area was found to be unsatisfactory. Stakeholders must therefore increase their efforts to align PCC units with existing MNCH service delivery points, improve women's decision-making autonomy, and focus on behavioral change communication to strengthen PCC practice. Plain language summary Preconception care (PCC) is a series of biomedical, mental, and psycho-social health services provided to women and a couple before pregnancy and throughout subsequent pregnancies for better endings. The main goal of the PCC is to improve maternal and child health outcomes, by-promoting wellness and providing preventive care. It can also be seen as an earlier chance for teenage girls, mothers, and children to live a better and longer-term healthy life. Pieces of PCC service packages suggested by the World Health Organization(WHO) are, micronutrient supplementation (Folate supplementation), infectious disease (STI/HIV) screening and testing, chronic disease screening and management, healthy diet therapy, vaccination, prevention of substance use (cessation of cigarette smoking and too much alcohol consumption), optimizing psychological health, counseling on the importance of exercise and reproductive health planning and implementation. Millions of women and new-borns have died in low-income countries due to impediments that arise before and exaggerate during pregnancies that are not deal with as part of pre-conception care. To the best of our knowledge, however, there is a lack of information about preconception care practice and its determinants in southern Ethiopia, including the study area. This study was therefore planned to evaluate the practice of preconception care and its determinants among mothers who recently gave birth in Wolkite town, southern Ethiopia, in 2020. Mothers who have given birth in the last 12 months have been randomly selected Household wealth status was determined through the application of principal component analysis(PCA). To see the weight of each explanatory variable on PCC, generalized linear regression with a Poisson type was done. Accordingly, the Education status of the mother, time spent to access nearby health facilities, availability of PCC unit, mother’s knowledge on PCC, being a model household, and women’s autonomy in decision making were identified as significant predictors of practice of PCC. Stakeholders must therefore increase their efforts to align PCC units with existing MNCH service delivery points, improve women's decision-making autonomy, and focus on behavioral change communication to strengthen PCC practice.

Folic acid (FA) supplementation prevents neural tube defects (NTDs), but the effects on other reproductive outcomes are unclear. While common recommendation is 0.4 mg/day in addition to regular nutrition, the most appropriate dose of FA is still under debate. We investigated the effects of a higher dose of periconception FA on reducing adverse reproductive outcomes. In this multicenter double-blind randomized controlled trial (RCT), 1060 women (aged 18–44 years and planning a pregnancy) were randomly assigned to receive 4.0 mg or 0.4 mg of FA daily. The primary outcome was the occurrence of congenital malformations (CMs). A composite outcome including one or more adverse pregnancy outcomes was also evaluated. A total of 431 women had a natural conception within 1 year. The primary outcome occurred in 8/227 (3.5%) women receiving 4.0 mg FA and 9/204 (4.4%) women receiving 0.4 mg FA (RR 0.80; 95%CI 0.31 to 2.03). The composite outcome occurred in 43/227 (18.9%) women receiving 4.0 mg FA and 75/204 (36.8%) women receiving 0.4 mg FA (RR 0.51; 95%CI 0.40 to 0.68). FA 4.0 mg supplementation was not associated with different occurrence of CMs, compared to FA 0.4 mg supplementation. However, FA 4.0 mg supplementation was associated with lower occurrence of other adverse pregnancy outcomes.

Background The period from conception to two years of life denotes a critical window of opportunity for promoting optimal growth and development of children. Poor nutrition and health in women of reproductive age and during pregnancy can negatively impact birth outcomes and subsequent infant survival, health and growth. Studies to improve birth outcomes and to achieve optimal growth and development in young children have usually tested the effect of standalone interventions in pregnancy and/or the postnatal period. It is not clearly known whether evidence-based interventions in the different domains such as health, nutrition, water sanitation and hygiene (WASH) and psychosocial care, when delivered together have a synergistic effect. Further, the effect of delivery of an intervention package in the pre and peri-conception period is not fully understood. This study was conceived with an aim to understand the impact of an integrated intervention package, delivered across the pre and peri-conception period, through pregnancy and till 24 months of child age on birth outcomes, growth and development in children. Methods An individually randomized controlled trial with factorial design is being conducted in urban and peri-urban low- to mid-socioeconomic neighbourhoods in South Delhi, India. 13,500 married women aged 18 to 30 years will be enrolled and randomized to receive either the pre and peri-conception intervention package or routine care (first randomization). Interventions will be delivered until women are confirmed to be pregnant or complete 18 months of follow up. Once pregnancy is confirmed, women are randomized again (second randomization) to receive either the intervention package for pregnancy and postnatal period or to routine care. Newborns will be followed up till 24 months of age. The interventions are delivered through different study teams. Outcome data are collected by an independent outcome ascertainment team. Discussion This study will demonstrate the improvement that can be achieved when key factors known to limit child growth and development are addressed together, throughout the continuum from pre and peri-conception until early childhood. The findings will increase our scientific understanding and provide guidance to nutrition programs in low- and middle-income settings. Trial registration Clinical Trial Registry – India #CTRI/2017/06/008908 ; Registered 23 June 2017, http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=19339&EncHid=&userName=society%20for%20applied%20studies

Multiple factors influence infant and child neurodevelopment in low resource settings. In offspring of participants in the preconception maternal nutrition trial, Women First (WF), we examined the impact of providing a preconception (Arm 1) or prenatal (Arm 2) nutrient supplement (compared to controls, Arm 3) on neurodevelopmental outcomes at 24 months; predictors of neurodevelopment scores; and associations of infant anthropometrics with neurodevelopmental scores. Follow‐up visits for anthropometry were conducted at 6‐, 12‐, 18‐ and 24‐month of age. At 24‐months, in a randomized subset, the Bayley Scales of Infant Development, 3rd edition (BSID‐III), including cognitive, motor and social‐emotional subscales, and the Family Care Indicators (FCI) questionnaire, assessing family and home environment, were completed. Multiple covariates (intervention arm, site, maternal sociodemographic characteristics, FCI subscales, birthweight and 6–24 months' change in anthropometry z‐scores, (e.g., ΔLAZ6–24) were evaluated by linear regression to predict BSID‐III outcomes and to assess associations of anthropometric changes with BSID‐III scores. The analysis consisted of 1386 infants (n = 441, 486, 459 for Arms 1, 2 and 3, respectively). None of the domain‐specific BSID‐III subscale scores differed by maternal intervention arm. Four covariates significantly predicted (p ≤ 0.01) all 3 BSID‐III subscales: secondary maternal education, ΔLAZ6–24, birthweight >2500 g, and FCI play materials. Linear growth was associated with all domains of neurodevelopment. The results underscore the multi‐dimensional aspects of child development represented by the nurturing care framework, including prenatal maternal nutrition, post‐natal growth, maternal education for responsive caregiving and opportunities for early learning. Key messages Preconception and prenatal maternal nutrition is important to ensure adequate fetal growth and healthy birthweight. Preconception and prenatal maternal nutritional supplementation was not associated with young child neurodevelopment but has been shown to improve post‐natal growth. Post‐natal linear growth is consistently associated with offspring neurodevelopment at 24 months. Maternal education to foster responsive caregiving, and opportunities for early learning in the home also positively impact offspring neurodevelopmental outcomes. These findings underscore the importance of multi‐dimensional aspects essential for children to reach their full developmental potential. The study examined the effects of maternal nutrition supplementation started before or during pregnancy (stopped at delivery) on offspring development at 24 months of age. The maternal intervention was not significantly associated with neurodevelopment, but maternal education, fetal and post‐natal growth and home environment were all associated with better developmental outcomes.

IntroductionMicronutrient deficiencies remain prominent drivers of adverse maternal and child health outcomes in Nepal. Gender-based inequalities and norms around women’s status and access to nutrition exacerbate poor nutritional status. Many newly married, preconception women lack adequate nutrition due to delayed engagement with the health system and limited autonomy to prioritise their own health. To address this gap, the Sumadhur trial provides multiple micronutrient supplements (MMS) alongside a household-level behavioural intervention targeting newly married women, their husbands and mothers-in-law.Methods and analysisThis will be a village-cluster randomised controlled trial across three districts in Nepal, enrolling 700 households, each comprising a triad of newly married woman, husband and mother-in-law. Villages will be randomised to receive either Sumadhur behavioural intervention+MMS (intervention) or standard of care (control). In intervention villages, participants will join weekly group sessions for 5 months, covering maternal and reproductive health, equitable household food allocation and nutrition information, and gender norms and household relationships. Women will receive three bottles of MMS (180 tablets each) over 18 months. Quantitative data collection at baseline, 6, 12 and 18 months will include surveys, venous blood draws (not at 12 months) and anthropometry. Primary outcomes will be anaemia prevalence and micronutrient status (iron, folate, vitamin B12). Secondary outcomes will include reproductive behaviours, birth outcomes and intrahousehold relationship dynamics. A nested qualitative component will employ longitudinal in-depth interviews with triads to understand the mechanisms of behavioural change. Impact will be measured through an intention-to-treat approach using mixed-effects logistic regression analyses.Ethics and disseminationThe study is approved by institutional review boards in the Ethics Board of the Nepal Health Research Council and the University of California, San Francisco IRB. Results will be disseminated to participating communities, local stakeholders and international audiences through workshops, peer-reviewed publications and policy briefs.All data will be made publicly available (deidentified) after the publication of the main impact paper.Trial registration numberNCT06810440.

Background: Reproductive life plan counseling (RLPC) is a tool to encourage women and men to reflect upon their reproduction, to avoid unintended pregnancies and negative health behavior that can threaten reproduction. The aim was to evaluate the effect of RLPC among women attending contraceptive counseling. Outcomes were knowledge about fertility and awareness of preconception health, use of contraception, and women's experience of RLPC. Material and methods: Swedish-speaking women, aged 20-40 years, were randomized to intervention group (IG) or control group (CG). Participants (n = 1,946) answered a questionnaire before and two months after (n = 1,198, 62%) the consultation. All women received standard contraceptive counseling, and the IG also received the RLPC, i.e. questions on reproductive intentions, information about fertility, and preconception health. Results: Women in the IG increased their knowledge about fertility: age and fertility, chances of getting pregnant, fecundity of an ovum, and chances of having a child with help of IVF. They also increased their awareness of factors affecting preconception health, such as to stop using tobacco, to refrain from alcohol, to be of normal weight, and to start with folic acid before a pregnancy. The most commonly used contraceptive method was combined oral contraceptives, followed by long-acting reversible contraception. Three out of four women (76%) in the IG stated that the RLPC should be part of the routine in contraceptive counseling. Conclusions: Knowledge about fertility and awareness of preconception health increased after the intervention. The RLPC can be recommended as a tool in contraceptive counseling.