Clinical trial NCT03099837: Tongji Maternal and Child Health Cohort
Official title: Maternal and Infant Health Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Weight Gain
Maternal; Diabetes Mellitus, Affecting Fetus
Diet Habit
Pregnancy Complications
Birth Outcomes
Breast Feeding
Growth and Development
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Maternal and Child Health Hospital of Hubei Province
name: Wuhan Central Hospital
name: Wuhan Maternal and Child Health Hospital
First posted: 2017-04-04
Enrollment: 8649
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The Tongji Maternal and Child Health enrolled healthy pregnant women at 8-16 weeks gestation when they attended their first antenatal visit at a maternity clinic in one of these following hospitals in Wuhan, China: Hubei Maternal and Child Health Hospital (HMCHH), The Central Hospital of Wuhan(CHW), Wuhan Maternal and Child Health Hospital (WMCHH), Jiang'an Maternal and Child Health Hospital(JMCHH). Babies born from these mothers will be followed up until the child is at least 10 years of age.

Brief summary: This is a population-based study to obtain data for the evaluation of current used recommendations for weight gain during pregnancy released by IOM (2007) and investigate the association between maternal diet and the health outcomes of mother and offspring.

Detailed description: This is an ongoing population-based prospective cohort study to obtain data for the evaluation of current used recommendations for weight gain during pregnancy released by IOM (2007) and investigate the association between maternal diet and the health outcomes of mother and offspring. 8649 pregnant have been recuited from the first trimester of pregnancy. All datas including the general information, sociodemographic facts, physical exam (body weight, height, blood pressure, etc), laboratory test (hemoglobin, glucose concentration, etc.) and dietary survey (FFQ, 24h food recall) have been collected during the cohort study. Blood sample leftover from the clinical use are remained and stored at -80℃for further measurements. Obstetric characteristics, maternal and perinatal outcomes have been observed and recorded. Growth and development paremeters such as weight, length and head circumference as well as disease information of infants have been collected , feeding pattern and feeding history will be surveyed. All data collected will be used for group analysis only and all private and individual records will be kept secret.

Eligibility criteria: Inclusion Criteria:

* Pregnant women attending the first visit (\<16 weeks ) at at a maternity clinic in one of these following hospitals in Wuhan, China: HMCHH, CHW,WMCHH,JMCHH.

Intention to visit the maternity clinic regularly in HMCHH or CHW or WMCHH or JMCHH.

* Intention to eventually deliver in HMCHH or CHW or WMCHH.
* The pregnant woman and her husband are Chinese.

Exclusion Criteria:

* Pregnant women on chemotherapy.
* Exclude women on certain medications - e.g. psychotropic drugs.
* Exclude women with significant medical conditions e.g. psychosis etc.

Primary outcomes:
measure: Effect of weight gain during pregnancy on maternal and child health
timeFrame: During pregnancy, infancy period and childhood, assessed up to 120 months
measure: Effect of factors in pregnancy and early postpartum period on maternal health
timeFrame: During pregnancy and postpartum period, assessed up to 12 months
measure: Influence of prenatal and early postnatal factors on child health
timeFrame: During pregnancy, infancy period and childhood, assessed up to 120 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Zhong C, Xiong G, Lin L, Li Q, Chen X, Zhang X, Zhang Y, Xu S, Wang X, Gao D, Wu M, Yang S, Han W, Sun G, Yang X, Hao L, Jin Z, Yang N. The association of maternal vaginal bleeding and progesterone supplementation in early pregnancy with offspring outcomes: a prospective cohort study. BMC Pregnancy Childbirth. 2022 May 5;22(1):390. doi: 10.1186/s12884-022-04711-1.
citation: Li Y, Zhou X, Zhang Y, Zhong C, Huang L, Chen X, Chen R, Wu J, Li Q, Sun G, Yin H, Xiong G, Hao L, Yang N, Yang X. Association of Maternal Dietary Patterns With Birth Weight and the Mediation of Gestational Weight Gain: A Prospective Birth Cohort. Front Nutr. 2021 Nov 26;8:782011. doi: 10.3389/fnut.2021.782011. eCollection 2021.
citation: Xiong T, Wu Y, Huang L, Chen X, Zhang Y, Zhong C, Gao Q, Hong M, Hu X, Yang X, Yang N, Hao L. Association of the maternal serum albumin level with fetal growth and fetal growth restriction in term-born singletons: a prospective cohort study. Fertil Steril. 2022 Feb;117(2):368-375. doi: 10.1016/j.fertnstert.2021.09.016. Epub 2021 Oct 20.
citation: Gao Q, Zhong C, Zhou X, Chen R, Xiong T, Hong M, Li Q, Kong M, Xiong G, Han W, Sun G, Yang X, Yang N, Hao L. Inverse association of total polyphenols and flavonoids intake and the intake from fruits with the risk of gestational diabetes mellitus: A prospective cohort study. Clin Nutr. 2021 Feb;40(2):550-559. doi: 10.1016/j.clnu.2020.05.053. Epub 2020 Jun 13.
citation: Zhou X, Chen R, Zhong C, Wu J, Li X, Li Q, Cui W, Yi N, Xiao M, Yin H, Xiong G, Han W, Hao L, Yang X, Yang N. Fresh fruit intake in pregnancy and association with gestational diabetes mellitus: A prospective cohort study. Nutrition. 2019 Apr;60:129-135. doi: 10.1016/j.nut.2018.09.022. Epub 2018 Oct 24.