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Table 1 Items from the World Health Organization Trial Registration Data Set

From: Associations between hydration state and pregnancy complications, maternal-infant outcomes: protocol of a prospective observational cohort study

Data CategoryInformation
Registration numberChiCTR1800019284, Chinese clinical trial registry
Registration State1,008,001 Prospective registration
Public titleStudy for the correlation between hydration state and pregnancy complications, maternal and infant outcomes during pregnancy
Scientific titleThe correlation between hydration state and pregnancy complications, maternal and infant outcomes during pregnancy
Approval of ethic committeeEthical Review Committee of the Hainan Medical University
Ethical approval project identification code2018–4
Date of approved by ethic committee20 May 2018
Study typeProspective observational study
Study designProspective observational study
Key inclusion and exclusion criteriaInclusion criteria: Aged between 21~35; at first trimester of pregnancy (before 13 weeks), in health state, without metabolic disease, oral diseases, and so on. Exclusion criteria: Aged < 21, or age > 35; not being at first trimester of pregnancy (before 13 weeks); With metabolic disease, oral diseases, and other diseases.
OutcomesUrine and blood osomolality, fluid intake, copeptin, pregnancy complications, maternal and infant outcomes
Collecting samplesUrine and blood
Recruitment stateNot initiated
Randomization Procedure (please state who generates the random number sequence and by what method)Not applicable. A convenience sampling method will be used to recriute participants.