Clinical Trial: Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Contro

Brief Summary: 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.

Detailed Summary:

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
  Sponsor: Centers for Disease Control and Prevention
  

  Current Primary Outcome: Perinatal mortality, i.e., the number of stillbirths (fetal deaths of 28 weeks or more of gestation) and the number of deaths within the first 0-6 days of life per 1000 births (live births and stillbirths) [ Time Frame: 20 weeks gestation to 6 days postpartum ]
  
  

  Original Primary Outcome:

  • - Perinatal mortality, i.e., the number of stillbirths
  • (fetal deaths of 28 weeks or more of gestation)
  • and the number of deaths within the first 0-6 days
  • of life per 1000 births (live births and still
  • births).
  • - Gastrointestinal side effects at monthly visits.
  
  
  

  Current Secondary Outcome:

  • Maternal anemia [ Time Frame: 24-28 weeks gestation ]
  • Maternal anemia [ Time Frame: 4-8 weeks postpartum ]
  • Infant gestational age at birth, preterm delivery [ Time Frame: delivery ]
  • Infant birth weight, low birth weight [ Time Frame: at birth ]
  • Infant low weight-for-height [ Time Frame: infant age 6 months and 12 months ]
  • Infant anemia [ Time Frame: 6 months and 12 months of age ]
  • maternal gastrointestinal side effects [ Time Frame: monthly from a month after enrollment until delivery ]
  
  
  

  Original Secondary Outcome:

  • - Maternal anemia between 24 and 28 weeks gestation,
  • - Maternal anemia at 4-8 weeks postpartum
  • - Infant gestational age at birth, preterm delivery
  • - Infant birth weight, low birth weight
  • - Infant low weight-for-height at age 6 and
  • 12 months
  • - Infant low weight-for-age at age 6 and 12 months
  • - Infant low height-for-age at age 6 and 12 months
  • - Infant anemia at age 6 and 12 months
  
  
  Information By: Centers for Disease Control and Prevention
  

  Dates:
  Date Received: August 22, 2005
  Date Started: May 2006
  Date Completion:
  Last Updated: March 18, 2011
  Last Verified: March 2011