Clinical trial NCT01404416: Effect of Antenatal Iron-contained Multiple Micronutrient Supplementation, Cesarean Delivery, and CDMR on Child Health
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight/Obesity
Anemia
Mental Development
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2011-07-28
Enrollment: 17000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

* all livebirths

Exclusion Criteria:

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baoding
country: China
facility: Mancheng Maternal and Child Health Hospital
state: Hebei
city: Langfang
country: China
facility: Xianghe Maternal and Child Health Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: Yuanshi Maternal and Child Health Hospital
state: Hebei
city: Tangshan
country: China
facility: Fengrun Maternal and Child Health Hospital
state: Hebei
city: Tangshan
country: China
facility: Laoting Maternal and Child Health Hospital
state: Hebei
Study officials:
References:
citation: Si KY, Li HT, Zhou YB, Li ZW, Zhang L, Zhang YL, Ye RW, Liu JM. Cesarean delivery on maternal request and common child health outcomes: A prospective cohort study in China. J Glob Health. 2022 Feb 26;12:11001. doi: 10.7189/jogh.12.11001. eCollection 2022.