Table 1 The questionnaire content of the CTBC

Section A:

basic information on pregnant women and pregnancy

Collects demographic information on pregnant women, basic information on this pregnancy, pregnancy history, abnormal fertility history, and family history of congenital malformation and genetic disease.

Includes the patient’s name, nationality, ID number, date of birth, telephone number, address, educational level, family income, date of her last menstrual period, length of her menstrual cycle, method of conception, date of ultrasound examination in early pregnancy, gestational age, gravidity, parity, history of miscarriage, history of birth defects, history of stillbirth, family history of heredity, and height and weight before pregnancy.

First-trimester pregnancy

Section B:

living habits, disease and drug exposure information on pregnant women and their husbands before pregnancy

1. Collects data on smoking, drinking, and folic acid supplementation from 3 months before pregnancy to the first 3 months after pregnancy.

2. Collects information on existing disease and exposure to drugs in pregnant women and their husbands within 6 months before conception.

1. Includes smoking, drinking and types, times, days and frequency of supplemental folic acid.

2. Includes the name of the disease, date of onset, current status of the disease (cured, improved, uncured, aggravated), name of the drug, method of administration, start and end time, days on medication, single dose, frequency, dosage form, manufacturer, and reason for use.

First-trimester pregnancy

Section C:

diseases and drug exposure information during pregnancy

Collects information on illnesses and medications used by pregnant women and their husbands during pregnancy.

Includes the name of the disease, date of onset, current status of the disease (cured, improved, uncured, aggravated), name of the drug, method of administration, start and end time, days on medication, dosage, frequency, dosage form, manufacturer, and reason for use.

First- and second-pregnancy trimester and discharge before hospital delivery

Section D:

pregnancy outcomes and condition of infants within 42 days after birth

Collects data on pregnancy outcomes and conditions of the infants within 42 days after birth.

Includes the date, place and manner of termination of pregnancy, cause of miscarriage or induction, number of births, foetal status (sex, birth status, weight, body length, head circumference, Apgar score), birth defects (name, location, size, diagnostic basis, diagnostic time and diagnostic hospital), and newborn status, hospitalization and birth defects within 42 days of birth.

discharge before hospital delivery or within 28–42 days after delivery