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Author Spotlight: Studying the Impact of Maternal Dietary Deficiencies on Long-Term Offspring Health Outcomes
Published on: June 28, 2024
Effectiveness of community-based folate-oriented tertiary interventions on incidence of fetus and birth defects: a
Mengru Li1,2, Yi Zhang1,2, Xiaotian Chen1,2
1Pediatric Heart Center, Children's Hospital of Fudan University, 399 Wan Yuan Road, Shanghai, 201102, People's Republic of China.
Insights
This study investigates folate interventions to reduce birth defects. Achieving optimal maternal folate levels before and during pregnancy is crucial for preventing fetal and neonatal abnormalities.
Area of Science:
- Obstetrics and Gynecology
- Public Health
- Genetics
Background:
- Birth defects are a leading cause of infant mortality globally, with largely unknown etiologies.
- Maternal folate status is critical for fetal organogenesis; folic acid supplementation reduces risks of neural tube and congenital heart defects.
- This trial addresses the challenge of achieving recommended periconceptional folate status to prevent birth defects.
Purpose of the Study:
- To evaluate the effectiveness of folate-oriented tertiary interventions during the periconception period.
- To assess the impact of these interventions on the incidence of fetal and birth defects.
- To inform community-based practices and policies for folic acid supplementation.
Main Methods:
- A single-blind, two-arm cluster randomized controlled trial conducted in Shanghai, China.
- Intervention group received folate status assessment, guidance, and re-evaluation to ensure red blood cell folate levels >400 ng/mL pre-pregnancy.
- Primary outcome: composite incidence of fetal defects, stillbirth, and neonatal birth defects up to 28 days postpartum.
Main Results:
- Data on main results are not yet available as this is a protocol description.
Conclusions:
- Achieving recommended maternal folate status pre- and during pregnancy remains a global challenge.
- This community-based intervention trial aims to reduce fetal and birth defects by optimizing folate status.
- Findings may guide policy for folic acid supplementation in primary care to prevent birth defects.
Background:
Birth defects are the main cause of fetal death, infant mortality and morbidity worldwide. However, the etiology of birth defects remains largely unknown. Maternal folate status during periconception plays an important role in organogenesis and folic acid supplement reduces the risk of neural tube defects, congenital heart diseases, and several other birth defects. This trial seeks to evaluate the effectiveness of folate-oriented tertiary interventions during periconception on the incidence of fetus and birth defects.
Methods:
This is a single-blind, two-arm cluster randomized controlled trial in Shanghai, China. Eligible women from 22 clusters are recruited at pre-pregnancy physical examinations clinical settings. Compared to the routine perinatal care group (control arm), folate-oriented tertiary interventions will be provided to the intervention arm. The core interventions consist of assessments of folate status and metabolism, folate intake guidance, and re-evaluation of folate status to ensure red blood cell folate level above 400 ng/ml (906 nmol/L) before pregnancy. Screening and consulting of fetus and birth defects, and treatments of birth defects during pregnancy and afterward will be provided to both arms. The primary outcome is a composite incidence of fetus defects, stillbirth, and neonatal birth defects identified from the confirmation of pregnancy to 28 days after birth. Secondary outcomes include maternal and offspring adverse complications and cost-effectiveness of folate-oriented tertiary interventions. This protocol adheres to the SPIRIT Checklist.
Discussion:
To achieve the recommended folate status before or during pregnancy is still a challenge worldwide. This community-based cluster-randomized controlled intervention trial will evaluate the effectiveness of a package of interventions aiming at achieving recommended maternal folate status covering pre- and during pregnancy in reducing fetus and birth defects. Our study has the potential to improve the community-based practice of reducing modifiable risk factors of disease and improving primary prevention of the defects in China. The procedures would formulate the policy on folic acid supplementation during periconception against birth defects in primary care settings.
Trial Registration:
Clinical Trial Registry, NCT03725878 . Prospectively registered on 31 October 2018.
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