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

Registration number

ChiCTR1800019284, Chinese clinical trial registry

Registration State

1,008,001 Prospective registration

Public title

Study for the correlation between hydration state and pregnancy complications, maternal and infant outcomes during pregnancy

Scientific title

The correlation between hydration state and pregnancy complications, maternal and infant outcomes during pregnancy

Approval of ethic committee

Ethical Review Committee of the Hainan Medical University

Ethical approval project identification code

2018–4

Date of approved by ethic committee

20 May 2018

Study type

Prospective observational study

Study design

Prospective observational study

Key inclusion and exclusion criteria

Inclusion 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.

Outcomes

Urine and blood osomolality, fluid intake, copeptin, pregnancy complications, maternal and infant outcomes

Collecting samples

Urine and blood

Recruitment state

Not 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.