Rationale, design, methodology and sample characteristics for the Vietnam pre-conceptual micronutrient supplementation trial (PRECONCEPT): a randomized controlled study

Abstract

BackgroundLow birth weight and maternal anemia remain intractable problems in many developing countries. The adequacy of the current strategy of providing iron-folic acid (IFA) supplements only during pregnancy has been questioned given many women enter pregnancy with poor iron stores, the substantial micronutrient demand by maternal and fetal tissues, and programmatic issues related to timing and coverage of prenatal care. Weekly IFA supplementation for women of reproductive age (WRA) improves iron status and reduces the burden of anemia in the short term, but few studies have evaluated subsequent pregnancy and birth outcomes.The Preconcept trial aims to determine whether pre-pregnancy weekly IFA or multiple micronutrient (MM) supplementation will improve birth outcomes and maternal and infant iron status compared to the current practice of prenatal IFA supplementation only. This paper provides an overview of study design, methodology and sample characteristics from baseline survey data and key lessons learned.Methods/designWe have recruited 5011 WRA in a double-blind stratified randomized controlled trial in rural Vietnam and randomly assigned them to receive weekly supplements containing either: 1) 2800 μg folic acid 2) 60 mg iron and 2800 μg folic acid or 3) MM. Women who become pregnant receive daily IFA, and are being followed through pregnancy, delivery, and up to three months post-partum. Study outcomes include birth outcomes and maternal and infant iron status. Data are being collected on household characteristics, maternal diet and mental health, anthropometry, infant feeding practices, morbidity and compliance.DiscussionThe study is timely and responds to the WHO Global Expert Consultation which identified the need to evaluate the long term benefits of weekly IFA and MM supplementation in WRA. Findings will generate new information to help guide policy and programs designed to reduce the burden of anemia in women and children and improve maternal and child health outcomes in resource poor settings.Trial registrationNCT01665378

Prevalence of Periconception Risk Factors for Adverse Pregnancy Outcomes in a Cohort of Urban Indian Women: Implications for Preconception Health Education

“…Data from this study suggested that preconception health promotion messages should combine advice on preconception folic acid supplementation, correction of anaemia and correction of body weight prior to conception. These messages would also be applicable to women in other LMIC settings as similar high prevalence of undernutrition and anaemia have been reported in Vietnam and Bangladesh [9,10]. That obesity is also an emerging risk in other low income settings has been reported for women in Nepal and Bangladesh [22].…”

“…The prevalence of preconception risk factors has been reported from studies, and ongoing surveillance [5][6][7][8]. Most of these reports are however from women in high income countries (HICs), where the general health status, awareness and education levels are higher than those from low and middle-income countries (LMICs) [9][10][11]. Data on risk exposures of women in low income settings are needed, as these exposures are likely to be dissimilar due to differences in socio-economic, demographic, cultural, dietary, lifestyle, environmental, regulatory and health systems characteristics.…”

Neither Preconceptional Weekly Multiple Micronutrient nor Iron–Folic Acid Supplements Affect Birth Size and Gestational Age Compared with a Folic Acid Supplement Alone in Rural Vietnamese Women: A Randomized Controlled Trial

“…Extensive data on sociodemographic characteristics, including socioeconomic status, age at marriage and at random assignment, ethnicity, and education were obtained for all women at baseline (13). Detailed obstetric and health history, anthropometric measurements, and venous blood samples were also obtained at baseline and the first prenatal visit.…”

“…PRECONCEPT is a double-blind RCT with 3 treatment arms of women receiving weekly micronutrient supplements before conception. The protocol has been described in detail elsewhere (13). All eligible WRA who provided written informed consent were randomly assigned to 1 of 3 prepregnancy groups, namely, weekly supplementation of 1) MMs, 2) IFA, or 3) FA only as the control group.…”

“…The objective of the current study known as PRECONCEPT (13) was to conduct a double-blind RCT in Vietnam to evaluate whether prepregnancy weekly IFA or multiple micronutrient (MM) supplementation improves birth outcomes compared with weekly FA supplementation. Given the important risk reduction for neural tube defects, FA was provided preconceptionally to the control group.…”