Study: NCT01192412

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 493 at risk

Adverse event: Elective termination
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 493 at risk

Adverse event: Death neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 14 affected / 493 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 12 affected / 493 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 493 at risk

Adverse event: High-level neonatal care for >48hr
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 141 affected / 480 at risk

Adverse event: Birthweight <10th percentile
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 79 affected / 491 at risk

Adverse event: Birthweight <3rd percentile
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 23 affected / 491 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 493 at risk

Adverse event: Transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 493 at risk

Adverse event: Placental abruption
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 493 at risk

Adverse event: Severe hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 200 affected / 493 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 241 affected / 493 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 488 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 488 at risk

Adverse event: Elective termination
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 488 at risk

Adverse event: Death neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 488 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 488 at risk

Adverse event: Neonatal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 488 at risk

Adverse event: High-level neonatal care for >48hr
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 139 affected / 479 at risk

Adverse event: Birthweight <10th percentile
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 96 affected / 488 at risk

Adverse event: Birthweight <3rd percentile
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 26 affected / 488 at risk

Adverse event: Transient ischemic attack or stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 488 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 488 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 488 at risk

Adverse event: Transfusion
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 488 at risk

Adverse event: Placental abruption
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 488 at risk

Adverse event: Severe hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 134 affected / 488 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 223 affected / 488 at risk