Study: NCT01127581

Adverse event: Disseminated intravascular coagulation #
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: # Postpartum Event
Frequency: 1 affected / 678 at risk

Adverse event: Polycythaemia *
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Supraventricular tachycardia *
Serious: yes
Organ System: Cardiac disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Adrenogenital syndrome *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Ankyloglossia congenital *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 3 affected / 678 at risk

Adverse event: Anomalous pulmonary venous connection *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Atrial septal defect *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 8 affected / 678 at risk

Adverse event: Congenital choroid plexus cyst *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Congenital pyelocaliectasis *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Cryptorchism *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 6 affected / 678 at risk

Adverse event: Hydrocele *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Hypospadias *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 4 affected / 678 at risk

Adverse event: Patent ductus arteriosus *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 4 affected / 678 at risk

Adverse event: Penile torsion *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 3 affected / 678 at risk

Adverse event: Pilonidal cyst congenital *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 3 affected / 678 at risk

Adverse event: Polydactyly *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 3 affected / 678 at risk

Adverse event: Pulmonary artery stenosis congenital *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Syndactyly *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Talipes *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: VACTERL syndrome *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 2 affected / 678 at risk

Adverse event: Ventricular septal defect *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 4 affected / 678 at risk

Adverse event: Intestinal obstruction *
Serious: yes
Organ System: Gastrointestinal disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Salivary gland enlargement *
Serious: yes
Organ System: Gastrointestinal disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Fever neonatal *
Serious: yes
Organ System: General disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Endometritis #
Serious: yes
Organ System: Infections and infestations
Notes: # Postpartum Event
Frequency: 2 affected / 678 at risk

Adverse event: Postpartum sepsis #
Serious: yes
Organ System: Infections and infestations
Notes: # Postpartum Event
Frequency: 1 affected / 678 at risk

Adverse event: Sepsis neonatal *
Serious: yes
Organ System: Infections and infestations
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Skull fracture *
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Urine output decreased *
Serious: yes
Organ System: Investigations
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Feeding disorder neonatal *
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Joint crepitation *
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Dysaesthesia #
Serious: yes
Organ System: Nervous system disorders
Notes: # Postpartum Event
Frequency: 1 affected / 678 at risk

Adverse event: Hypoxic-ischaemic encephalopathy *
Serious: yes
Organ System: Nervous system disorders
Notes: \* Neonatal Event
Frequency: 4 affected / 678 at risk

Adverse event: Abnormal labour affecting foetus +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 13 affected / 678 at risk

Adverse event: Drug withdrawal syndrome neonatal *
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Foetal acidosis *
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Foetal heart rate disorder +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 65 affected / 678 at risk

Adverse event: Hypoglycaemia neonatal *
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 3 affected / 678 at risk

Adverse event: Neonatal disorder *
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Postpartum haemorrhage #
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: # Postpartum Event
Frequency: 2 affected / 678 at risk

Adverse event: Premature separation of placenta +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 1 affected / 678 at risk

Adverse event: Puerperal pyrexia #
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: # Postpartum Event
Frequency: 1 affected / 678 at risk

Adverse event: Uterine contractions abnormal +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 1 affected / 678 at risk

Adverse event: Uterine rupture +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 1 affected / 678 at risk

Adverse event: Weight decrease neonatal *
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Chordee *
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Neonatal aspiration *
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Transient tachypnoea of the newborn *
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 678 at risk

Adverse event: Deep vein thrombosis #
Serious: yes
Organ System: Vascular disorders
Notes: # Postpartum Event
Frequency: 1 affected / 678 at risk

Adverse event: Hypertension #
Serious: yes
Organ System: Vascular disorders
Notes: # Postpartum Event
Frequency: 1 affected / 678 at risk

Adverse event: Abnormal labour affecting foetus +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 59 affected / 678 at risk

Adverse event: Arrested labour +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 96 affected / 678 at risk

Adverse event: Caput succedaneum *
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 58 affected / 678 at risk

Adverse event: Chorioamnionitis +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 38 affected / 678 at risk

Adverse event: Foetal heart rate disorder +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 124 affected / 678 at risk

Adverse event: Hyperbilirubinaemia neonatal *
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 62 affected / 678 at risk

Adverse event: Meconium in amniotic fluid +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 120 affected / 678 at risk

Adverse event: Postpartum haemorrhage #
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: # Postpartum Event
Frequency: 40 affected / 678 at risk

Adverse event: Umbilical cord around neck *
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 184 affected / 678 at risk

Adverse event: Neonatal respiratory depression *
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \* Neonatal Event
Frequency: 34 affected / 678 at risk

Adverse event: Infection prophylaxis *
Serious: no
Organ System: Surgical and medical procedures
Notes: \* Neonatal Event
Frequency: 46 affected / 678 at risk

Adverse event: Pericarditis #
Serious: yes
Organ System: Cardiac disorders
Notes: # Postpartum Event
Frequency: 1 affected / 680 at risk

Adverse event: Supraventricular tachycardia +
Serious: yes
Organ System: Cardiac disorders
Notes: + Intrapartum Event
Frequency: 1 affected / 680 at risk

Adverse event: Anal atresia *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Ankyloglossia congenital *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 2 affected / 680 at risk

Adverse event: Atrial septal defect *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 6 affected / 680 at risk

Adverse event: Cataract congenital *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Congenital hydronephrosis *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Congenital nose malformation *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Congenital pyelocaliectasis *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Cryptorchism *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 2 affected / 680 at risk

Adverse event: Hydrocele *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Hypospadias *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 4 affected / 680 at risk

Adverse event: Patent ductus arteriosus *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 4 affected / 680 at risk

Adverse event: Penile torsion *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Phimosis *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 3 affected / 680 at risk

Adverse event: Pilonidal cyst congenital *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 7 affected / 680 at risk

Adverse event: Polydactyly *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 3 affected / 680 at risk

Adverse event: Supernumerary nipple *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 2 affected / 680 at risk

Adverse event: Ventricular septal defect *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Vitreous haemorrhage *
Serious: yes
Organ System: Eye disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Anal fistula *
Serious: yes
Organ System: Gastrointestinal disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Endometritis #
Serious: yes
Organ System: Infections and infestations
Notes: # Postpartum Event
Frequency: 1 affected / 680 at risk

Adverse event: Pneumonia *
Serious: yes
Organ System: Infections and infestations
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Pneumonia #
Serious: yes
Organ System: Infections and infestations
Notes: # Postpartum Event
Frequency: 1 affected / 680 at risk

Adverse event: Sepsis neonatal *
Serious: yes
Organ System: Infections and infestations
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Septic shock *
Serious: yes
Organ System: Infections and infestations
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Urine output decreased *
Serious: yes
Organ System: Investigations
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Feeding disorder neonatal *
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: \* Neonatal Event
Frequency: 2 affected / 680 at risk

Adverse event: Joint crepitation *
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Muscular weakness #
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: # Postpartum Event
Frequency: 1 affected / 680 at risk

Adverse event: Encephalopathy neonatal *
Serious: yes
Organ System: Nervous system disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Paraesthesia #
Serious: yes
Organ System: Nervous system disorders
Notes: # Postpartum Event
Frequency: 1 affected / 680 at risk

Adverse event: Drug withdrawal syndrome neonatal *
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Erb's palsy *
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Foetal heart rate disorder +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 46 affected / 680 at risk

Adverse event: Hypoglycaemia neonatal *
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 2 affected / 680 at risk

Adverse event: Postpartum haemorrhage #
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: # Postpartum Event
Frequency: 3 affected / 680 at risk

Adverse event: Retained placenta or membranes #
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: # Postpartum Event
Frequency: 1 affected / 680 at risk

Adverse event: Weight decrease neonatal *
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Anxiety #
Serious: yes
Organ System: Psychiatric disorders
Notes: # Postpartum Event
Frequency: 1 affected / 680 at risk

Adverse event: Hydronephrosis *
Serious: yes
Organ System: Renal and urinary disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Testicular torsion *
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Vulval haematoma #
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: # Postpartum Event
Frequency: 1 affected / 680 at risk

Adverse event: Neonatal aspiration *
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \* Neonatal Event
Frequency: 2 affected / 680 at risk

Adverse event: Neonatal respiratory depression *
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Neonatal respiratory distress syndrome *
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Pneumothorax *
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 680 at risk

Adverse event: Hypertension #
Serious: yes
Organ System: Vascular disorders
Notes: # Postpartum Event
Frequency: 1 affected / 680 at risk

Adverse event: Abnormal labour affecting foetus +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 19 affected / 680 at risk

Adverse event: Arrested labour +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 128 affected / 680 at risk

Adverse event: Caput succedaneum *
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 60 affected / 680 at risk

Adverse event: Chorioamnionitis +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 59 affected / 680 at risk

Adverse event: Foetal heart rate disorder +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 138 affected / 680 at risk

Adverse event: Hyperbilirubinaemia neonatal *
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 78 affected / 680 at risk

Adverse event: Meconium in amniotic fluid +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 92 affected / 680 at risk

Adverse event: Postpartum haemorrhage #
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: # Postpartum Event
Frequency: 37 affected / 680 at risk

Adverse event: Umbilical cord around neck *
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 194 affected / 680 at risk

Adverse event: Neonatal respiratory depression *
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \* Neonatal Event
Frequency: 30 affected / 680 at risk

Adverse event: Infection prophylaxis *
Serious: no
Organ System: Surgical and medical procedures
Notes: \* Neonatal Event
Frequency: 63 affected / 680 at risk