Clinical trial NCT02586220: Iodine Nutrition During Pregnancy and Related Neonatal Physical Development
Official title: Iodine Nutrition During Pregnancy and Related Neonatal Physical Development
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Iodine Deficiency
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2015-10-26
Enrollment: 250
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 250 pregnant women recruited from antenatal outpatient clinics in Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine, China.

Brief summary: Recent studies have found, in both developed and developing countries, there is still a considerable number of pregnant women in iodine deficiency status.Our overall aim is to monitor iodine status of pregnant women in China, and to examine the correlation between maternal urine iodine concentration (UIC) and newborn physical development level.

Detailed description: Background: Recent studies have found, in both developed and developing countries, there is still a considerable number of pregnant women in iodine deficiency status. Our overall aim is to monitor iodine status of pregnant women in China, and to examine the correlation between maternal urine iodine concentration (UIC) and newborn physical development level.

Design: prospective cohort study

Methods: During August - December 2015,250 participants(28-32 weeks' gestation) were selected to participate in the study.The investigators collect the spot urine samples(n=750) once every two weeks.

Setting: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine.

Participants: 150 normal pregnant women and 100 pregnant women with gestational diabetes (28-32 weeks' gestation) and their newborns were selected to participate the study.

Eligibility criteria: Inclusion Criteria:

* 22-35 years,
* 28-32 weeks' gestation,

Exclusion Criteria:

* a known history of thyroid disease in the non-pregnant state and previous.

Primary outcomes:
measure: urinary iodine (UI) concentrations
timeFrame: up to three months
Secondary outcomes:
measure: thyroid stimulating hormone level of newborns
timeFrame: up to three months
measure: daily iodine intake of pregnant women
timeFrame: up to three months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medcine
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Qingya Tang, MMed
role: PRINCIPAL_INVESTIGATOR
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