Study: NCT03070600

Adverse event: Infant Death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Participant experienced a neonatal or infant death during the study period
Frequency: 51 affected / 2250 at risk

Adverse event: Infant Hospitalization
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Participant experienced an infant hospitalization during the study period
Frequency: 13 affected / 2250 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Participant was hospitalized during the study period
Frequency: 11 affected / 2250 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Loss of pregnancy before 20 weeks gestational age
Frequency: 9 affected / 2250 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Loss of pregnancy after 20 weeks gestational age
Frequency: 51 affected / 2250 at risk

Adverse event: Kicked out of home
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 2250 at risk

Adverse event: Experienced violence of abuse
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 2250 at risk

Adverse event: Persistent or significant psychosocial distress
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 2250 at risk

Adverse event: Partner thought participant was HIV positive
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 2250 at risk

Adverse event: Infant Death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Participant experienced a neonatal or infant death during the study period
Frequency: 47 affected / 2197 at risk

Adverse event: Infant Hospitalization
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Participant experienced an infant hospitalization during the study period
Frequency: 3 affected / 2197 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Participant was hospitalized during the study period
Frequency: 18 affected / 2197 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Loss of pregnancy before 20 weeks gestational age
Frequency: 8 affected / 2197 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Loss of pregnancy after 20 weeks gestational age
Frequency: 41 affected / 2197 at risk

Adverse event: Benign hydatidiform mole
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 2197 at risk

Adverse event: Kicked out of home
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 2197 at risk

Adverse event: Experienced violence of abuse
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 2197 at risk

Adverse event: Breach of confidentiality
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 2197 at risk

Adverse event: Suicidal behaviour
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2197 at risk

Adverse event: Persistent or significant psychosocial distress
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 2197 at risk