Study: NCT01631747

Adverse event: Pregnancy Loss/Termination
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Miscarriage, Termination, Antepartum stillbirth
Frequency: 4 affected / 141 at risk

Adverse event: Abruption
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Placenta Abruption
Frequency: 1 affected / 141 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Preeclampsia / severe preeclampsia / HELLP / eclampsia / high blood pressure
Frequency: 6 affected / 141 at risk

Adverse event: Cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Cholestasis / elevated liver enzymes
Frequency: 1 affected / 141 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 141 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 141 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Infections and infestations
Notes: Intrapartum maternal infection
Frequency: 1 affected / 141 at risk

Adverse event: Postpartum maternal infection
Serious: yes
Organ System: Surgical and medical procedures
Notes: small bowel perforation
Frequency: 1 affected / 141 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Fetal Congenital anomaly; small centricular septal defects, pulmonary stenosis dysplastic pulmonary valve, trisomy 13, gastroschisis, esophagaeal atresia, trisomy 21, duodenal atresia.
Frequency: 7 affected / 141 at risk

Adverse event: NICU admission
Serious: yes
Organ System: General disorders
Notes: Neonatal Intensive care unit admission
Frequency: 18 affected / 141 at risk

Adverse event: Small for dates baby
Serious: no
Organ System: Endocrine disorders
Notes: Neonate born small for gestational age
Frequency: 5 affected / 141 at risk

Adverse event: Pregnancy Loss/Termination
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Miscarriage, Termination, Antepartum stillbirth
Frequency: 1 affected / 140 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Preeclampsia / severe preeclampsia / HELLP / eclampsia / high blood pressure
Frequency: 6 affected / 140 at risk

Adverse event: Cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Cholestasis / elevated liver enzymes
Frequency: 1 affected / 140 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 140 at risk

Adverse event: Vasa praevia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Placenta Abnormality
Frequency: 1 affected / 140 at risk

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: respiratory compromise
Frequency: 1 affected / 140 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Fetal Congenital anomaly; small centricular septal defects, pulmonary stenosis dysplastic pulmonary valve, trisomy 13, gastroschisis, esophagaeal atresia, trisomy 21, duodenal atresia.
Frequency: 2 affected / 140 at risk

Adverse event: NICU admission
Serious: yes
Organ System: General disorders
Notes: Neonatal Intensive care unit admission
Frequency: 12 affected / 140 at risk

Adverse event: Small for dates baby
Serious: no
Organ System: Endocrine disorders
Notes: Neonate born small for gestational age
Frequency: 3 affected / 140 at risk