Stillbirth Clinical Trial
Official title:
Impact of Iron/Folic Acid Versus Multimicronutrient Versus Folic Acid Supplements During Pregnancy on Mortality, Morbidity, and Complications During Pregnancy, Labor, and Delivery: A Randomized Controlled Trial in China
The purpose of this study is to determine whether a daily prenatal supplement of iron plus folic acid or a daily prenatal supplement with multiple vitamins and minerals given to women from their first prenatal visit through delivery reduces perinatal mortality compared with a daily prenatal supplement of folic acid alone.
In the project area in China, the rate of perinatal mortality (stillbirths and infant deaths
within 6 days of birth) is two times that of the United States. Causes of perinatal
mortality include, but are not limited to, low birth weight and preterm delivery. Anemia
(low hemoglobin) among pregnant women is associated with low birth weight and preterm
delivery and also is elevated in the project area. Supplements of iron, folic acid, and
other vitamins and minerals can prevent anemia among pregnant women, but the effects of
these supplements on other maternal and infant health outcomes are unclear.
Since 1993, the People's Republic of China has recommended that newly married women, and
those who plan pregnancy, take 400μg of folic acid daily through the first trimester of
pregnancy. Although WHO recommends that pregnant women take iron and folic acid supplements,
there is currently no national recommendation that pregnant women in China take iron or
other vitamin or mineral supplements (other than folic acid). UNICEF is now testing a
prenatal vitamin and mineral supplement in programs to prevent low birth weight. Our study
will provide additional information about the health impact of the UNICEF prenatal
supplement versus an iron and folic acid supplement versus folic acid alone.
Comparisons:
- Infants of women who receive daily prenatal supplements that contain 400μg folic acid
alone, will be compared with infants of women who receive daily supplements that
contain 30 mg iron and 400 μg folic acid.
- Infants of women who receive daily supplements that contain 30 mg iron and 400 μg folic
acid will be compared with infants of women who receive a daily supplement containing
30 mg iron, 400μg folic acid and other vitamins and minerals (UNICEF formulation).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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