Effect of Antenatal Iron-contained Multiple Micronutrient Supplementation, Cesarean Delivery, and CDMR on Child Health

Completed

• Conditions: Anemia; Mental Development; Overweight/Obesity

• Registration Number: NCT01404416
• Lead Sponsor: Peking University

Brief Summary

The follow-up study was based on our previous nutritional intervention trial entitled "Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality (NCT00133744)". We followed up all livebirths born to women of the trial to measure their height, weight, and hemoglobin and to implement a questionaire survey (including developmental milestones, disease history, breast feeding, passive smoking, et al). We selected a sub-sample of infants to assess their IQ, emotional and behavioral problem, and language development status. The outcomes of interest include death, body mass index, overweight/ obesity, stunting/ wasting/ thinness, anemia, developmental milestones, IQ, emotional and behavioral disorder, language developmental status, and disease history. Other interesting exposure includes breast feeding, passive smoking, et al. We hypothesize that intrauterine nutritional exposure has an impact on offspring's physical, mental, and language development. We also hypothesize that cesarean delivery including CDMR has an impact on offspring's these outcomes.

Detailed Description

The follow-up study was based on our previous nutritional intervention trial entitled "Impact of Prenatal Vitamin/Mineral Supplements on Perinatal Mortality (NCT00133744)". We followed up all livebirths born to women of the trial to measure their height, weight, and hemoglobin and to implement a questionaire survey (including developmental milestones, disease history, breast feeding, passive smoking, et al). We selected 1200 \<30 months infants to assess their IQ with Bayley scale, emotional and behavioral problem with CBCL scale, and language development status with LDS scale. We also selected 1500 \>30 months children to measure their emotional and behavioral problem with CBCL scale. The exposure groups include intrauterine nutritional exposure and cesarean delivery exposure as well as CDMR. The outcomes of interest include death, body mass index, overweight/ obesity, stunting/ wasting/ thinness, anemia, developmental milestones, IQ, emotional and behavioral disorder, language developmental status, and disease history. Other interesting exposure includes breast feeding, passive smoking, et al. We hypothesize that intrauterine nutritional exposure has an impact on offspring's physical, mental, and language development. We also hypothesize that cesarean delivery including CDMR has an impact on offspring's these outcomes.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-07-27
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-28
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-04
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17000

Inclusion Criteria

• all livebirths

Exclusion Criteria

• died
• moved out
• refused to participate
• being incapable of participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (5)

Mancheng Maternal and Child Health Hospital; 🇨🇳 Baoding, Hebei, China

Xianghe Maternal and Child Health Hospital; 🇨🇳 Langfang, Hebei, China

Yuanshi Maternal and Child Health Hospital; 🇨🇳 Shijiazhuang, Hebei, China

Fengrun Maternal and Child Health Hospital; 🇨🇳 Tangshan, Hebei, China

Laoting Maternal and Child Health Hospital; 🇨🇳 Tangshan, Hebei, China