NCT03099837

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,649

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2013

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2017

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
Last Updated

August 4, 2020

Status Verified

August 1, 2020

Enrollment Period

10 years

First QC Date

March 17, 2017

Last Update Submit

August 1, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Effect of weight gain during pregnancy on maternal and child health

    To regularly measure the weight gains of pregnant women during pregnancy, and examine their association with maternal and child health.

    During pregnancy, infancy period and childhood, assessed up to 120 months

  • Effect of factors in pregnancy and early postpartum period on maternal health

    To examine the role of maternal nutrition, lifestyle, emotional health, and other environmental factors in pregnancy or postpartum period that can influence future maternal risk of metabolic disorders and even lead to complications of pregnancy, such as gestational diabetes mellitus.

    During pregnancy and postpartum period, assessed up to 12 months

  • Influence of prenatal and early postnatal factors on child health

    To examine the role of maternal nutrition, lifestyle, emotional health, breastfeeding, and other environmental factors in infancy that can influence the development of phenotypes in childhood which confer risk for later metabolic and mental disorders.

    During pregnancy, infancy period and childhood, assessed up to 120 months

Study Arms (3)

Pregnant mothers

infants

children

Eligibility Criteria

Sexfemale
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Kong M, Zhong C, Gao Q, Zhou X, Chen R, Xiong G, Hao L, Yang X, Lu Z, Yang N. Association of elevated mid-pregnancy maternal plasma ferritin concentrations and triglyceride concentrations with the risk of gestational diabetes mellitus: A prospective cohort study. Diabetes Metab Res Rev. 2023 Sep;39(6):e3637. doi: 10.1002/dmrr.3637. Epub 2023 Apr 13.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Weight GainDiabetes MellitusFeeding BehaviorPregnancy ComplicationsBreast Feeding

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior, AnimalBehaviorFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 17, 2017

First Posted

April 4, 2017

Study Start

January 10, 2013

Primary Completion

January 10, 2023

Study Completion

January 10, 2023

Last Updated

August 4, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share