This questionnaire provides possible parental and neonatal data elements from which relevant points can be selected when establishing a questionnaire of pregnancy exposure to medicinal products.
A. General Information
• Prospective / retrospective case
• Date of initial contact with marketing authorization holder
• Source of information (‘reporter qualification’ in ICH-E2B; a more specific description can be provided in the case narrative e.g. pregnant woman, primary care physician, obstetrician, pediatrician, other)
• Identification of reporter
• Additional identification of the gynecologist-obstetrician (if reporter is the patient or the primary physician), and the address of the place where the mother plans to deliver
B. Maternal Information
• Identification of patient
• Date of birth (or age)
• Weight, height
Obstetrical history
• Number of previous pregnancies and outcome (live birth, miscarriage, elective termination with specification of gestational length and context, late foetal death, ectopic pregnancy, molar pregnancy)
• Previous maternal pregnancy complications- Previous foetal/neonatal abnormalities and type
• History of subfertility
Maternal medical history
Risk factors for adverse pregnancy outcomes including environmental, occupational, substance abuse exposures and medical disorders such as hypertension, diabetes, seizure disorder, thyroid disorder, asthma, allergic disease, heart disease, psychiatric or mental health disorders, sexual transmitted disorders, hepatitis, AIDS (specify viral load, CD4 count), and other, including other predisposing factors for neurodevelopmental disorders.
Current pregnancy
• Date of last menstrual period (LMP)
• Gestational age at the time of the first contact with MAH (specify if based on ultrasound or LMP)
• Gestational age at the time of drug exposure, preferably based on ultrasound and with the method of determining gestational age specified
Estimated date of delivery
• Number of foetuses
• Treatment for infertility (specify)
• Exposure to products subject to medical prescription, OTC products, pregnancy supplements such as folic acid, multivitamins:
- Name
- Dosage & route
- Date of first use, date of end of treatment, duration
- Indication
• Use of tobacco, alcohol, illicit drugs (specify amount and if stopped during pregnancy)
• Results of serology tests, e.g. rubella, toxoplasmosis etc.
• Complications during pregnancy and date (including any adverse drug reactions)
• Disease course(s) during pregnancy and any complications
• Antenatal check-up (specify dates and results), e.g. foetal ultrasound, serum markers (AFP, other), chorionic villi biopsy (CVS), amniocentesis, non-invasive prenatal test
Delivery
• Mode of delivery
• Labor / delivery complications (foetal distress, amniotic fluid abnormal)
• Abnormal placenta
Family history
• History of congenital abnormality, psychomotor retardation in the family (specify paternal/maternal and relationship)
• Consanguinity between parents (specify degree)
C. Paternal Information If Appropriate
General information
- Age or birth date
Relevant medical history
Medical products exposure
D. Neonatal Information
Initial
• Source of information
• Date of receipt of information
• Outcome of pregnancy and date (ectopic pregnancy, molar pregnancy, miscarriage, elective termination, late foetal death and stillbirth, live birth)
• Date of birth
• Gestational age at birth
• Gender of neonate
• Results of neonatal physical examination including:
- Weight at birth
- Length, head circumference at birth
• Malformation/anomalies diagnosed in a foetus or at birth
• Conditions at birth (including Apgar scores at 1 and 5 minutes, need for resuscitation, admission to intensive care unit)
• Dysmaturity
• Neonatal illness, hospitalization, drug therapies
Follow-up
• Source and date of information
• Malformation/anomalies diagnosed and (cyto) genetic testing results obtained since initial report
• Developmental assessment
• Infant illnesses, hospitalizations, drug therapies, breastfeeding
E. Foetal Information in The Case of Elective Termination, Spontaneous Abortion and Late Foetal Death
• Source of information
• Date of receipt of information
• Reason for termination
• Gestational age at termination
• Results of physical examination (gender, external anomalies) and pathology