We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01404416
Recruitment Status : Completed
First Posted : July 28, 2011
Last Update Posted : June 8, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Overweight/Obesity Anemia Mental Development

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 Design

Study Type : Observational
Actual Enrollment : 17000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Antenatal Iron-contained Multiple Micronutrient Supplementation, Cesarean Delivery, and CDMR on Child Health- A Post-trial Follow-up Chinese Study
Study Start Date : May 2011
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
all livebirths born to women of our previous trial (NCT00133744) who were from Laoting, Fengrun, Xianghe, Mancheng, and Yuanshi counties of China.
Criteria

Inclusion Criteria:

  • all livebirths

Exclusion Criteria:

  • died
  • moved out
  • refused to participate
  • being incapable of participation
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404416


Locations
China, Hebei
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
Sponsors and Collaborators
Peking University
More Information

Responsible Party: Liu Jianmeng, Institute of Reproductive and Child Health, Peking University
ClinicalTrials.gov Identifier: NCT01404416     History of Changes
Other Study ID Numbers: 5119001
First Posted: July 28, 2011    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs