Study: NCT00308711

Adverse event: Arrested labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Also included terms such as Failure to progress
Frequency: 25 affected / 428 at risk

Adverse event: Cephalopelvic Disproportion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 14 affected / 428 at risk

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 428 at risk

Adverse event: Herpes simplex
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 428 at risk

Adverse event: Abnormal labour affecting foetus
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 428 at risk

Adverse event: Foetal heart rate disorder
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 46 affected / 428 at risk

Adverse event: Foetal malpresentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 428 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 428 at risk

Adverse event: Uterine contractions abnormal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 428 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 428 at risk

Adverse event: Dilated cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 428 at risk

Adverse event: Tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 428 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 428 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 428 at risk

Adverse event: Endometritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 428 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 428 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 428 at risk

Adverse event: Urine output decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 428 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 428 at risk

Adverse event: Uterine atony
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 428 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 428 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 428 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 428 at risk

Adverse event: Bradycardia neonatal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 428 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 10 affected / 428 at risk

Adverse event: Hyperbilirubinaemia neonatal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 428 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 428 at risk

Adverse event: Apgar score low
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 428 at risk

Adverse event: ABO hemolytic disease of the newborn
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 428 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 428 at risk

Adverse event: Neonatal aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 428 at risk

Adverse event: Neonatal respiratory depression
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 428 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 428 at risk

Adverse event: transient tachypnea of the newborn
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 428 at risk

Adverse event: Infection prophylaxis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 428 at risk

Adverse event: Abnormal labour affecting foetus
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 24 affected / 428 at risk

Adverse event: Amniotic cavity infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 17 affected / 428 at risk

Adverse event: Foetal heart rate disorder
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 130 affected / 428 at risk

Adverse event: Meconium in amniotic fluid
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 38 affected / 428 at risk

Adverse event: Uterine contractions abnormal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 83 affected / 428 at risk

Adverse event: Uterine hypertonus
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 17 affected / 428 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 18 affected / 428 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 21 affected / 428 at risk

Adverse event: Perineal injury
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 21 affected / 428 at risk

Adverse event: post partum hemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 17 affected / 428 at risk

Adverse event: neonatal hyperbilirubinemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 428 at risk

Adverse event: Apgar score low
Serious: no
Organ System: Investigations
Frequency: 10 affected / 428 at risk

Adverse event: Arrested labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Also included terms such as Failure to progress
Frequency: 36 affected / 443 at risk

Adverse event: Cephalopelvic Disproportion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 35 affected / 443 at risk

Adverse event: Wolff-Parkinson-White syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 443 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 443 at risk

Adverse event: Foetal heart rate disorder
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 47 affected / 443 at risk

Adverse event: Foetal malpresentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 443 at risk

Adverse event: Uterine contractions abnormal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 443 at risk

Adverse event: Uterine hypertonus
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 443 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 443 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 443 at risk

Adverse event: Liver abscess
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 443 at risk

Adverse event: Endometritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 443 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 443 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 443 at risk

Adverse event: Pleuritic pain
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 443 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 7 affected / 443 at risk

Adverse event: Neonatal hypothermia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 443 at risk

Adverse event: Hyperbilirubinaemia neonatal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 5 affected / 443 at risk

Adverse event: Apgar score low
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 443 at risk

Adverse event: ABO hemolytic disease of the newborn
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 8 affected / 443 at risk

Adverse event: Cephalhaematoma
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 443 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 443 at risk

Adverse event: Neonatal aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 443 at risk

Adverse event: Neonatal respiratory depression
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 443 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 443 at risk

Adverse event: transient tachypnea of the newborn
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 443 at risk

Adverse event: Infection prophylaxis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 443 at risk

Adverse event: Abnormal labour affecting foetus
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 12 affected / 443 at risk

Adverse event: Amniotic cavity infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 30 affected / 443 at risk

Adverse event: Foetal heart rate disorder
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 129 affected / 443 at risk

Adverse event: Meconium in amniotic fluid
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 45 affected / 443 at risk

Adverse event: Uterine contractions abnormal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 61 affected / 443 at risk

Adverse event: Uterine hypertonus
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 16 affected / 443 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 21 affected / 443 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 25 affected / 443 at risk

Adverse event: Perineal injury
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 28 affected / 443 at risk

Adverse event: post partum hemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 16 affected / 443 at risk

Adverse event: neonatal hyperbilirubinemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 6 affected / 443 at risk

Adverse event: Apgar score low
Serious: no
Organ System: Investigations
Frequency: 10 affected / 443 at risk

Adverse event: Arrested labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Also included terms such as Failure to progress
Frequency: 33 affected / 436 at risk

Adverse event: Cephalopelvic Disproportion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 29 affected / 436 at risk

Adverse event: Foetal heart rate disorder
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 35 affected / 436 at risk

Adverse event: Foetal malpresentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 436 at risk

Adverse event: Pregnancy-induced hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 436 at risk

Adverse event: Umbilical cord prolapse
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 436 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 436 at risk

Adverse event: Ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 436 at risk

Adverse event: Chest pain
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 436 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 436 at risk

Adverse event: Endometritis
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 436 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 436 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Peroneal nerve palsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 436 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 436 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 436 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 436 at risk

Adverse event: Urinary retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 436 at risk

Adverse event: Uterine atony
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 436 at risk

Adverse event: Polycythaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 436 at risk

Adverse event: Bradycardia neonatal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 436 at risk

Adverse event: tachcardia foetal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 436 at risk

Adverse event: Congenital anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 7 affected / 436 at risk

Adverse event: Hyperbilirubinaemia neonatal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 8 affected / 436 at risk

Adverse event: Group B sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 436 at risk

Adverse event: Apgar score low
Serious: yes
Organ System: Investigations
Frequency: 2 affected / 436 at risk

Adverse event: ABO hemolytic disease of the newborn
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 436 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 436 at risk

Adverse event: Neonatal aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 436 at risk

Adverse event: Neonatal respiratory depression
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 436 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 436 at risk

Adverse event: transient tachypnea of the newborn
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 436 at risk

Adverse event: Infection prophylaxis
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 436 at risk

Adverse event: Abnormal labour affecting foetus
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 28 affected / 436 at risk

Adverse event: Amniotic cavity infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 22 affected / 436 at risk

Adverse event: Foetal heart rate disorder
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 132 affected / 436 at risk

Adverse event: Meconium in amniotic fluid
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 44 affected / 436 at risk

Adverse event: Uterine contractions abnormal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 81 affected / 436 at risk

Adverse event: Uterine hypertonus
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 25 affected / 436 at risk

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 23 affected / 436 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 20 affected / 436 at risk

Adverse event: Perineal injury
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 21 affected / 436 at risk

Adverse event: post partum hemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 21 affected / 436 at risk

Adverse event: neonatal hyperbilirubinemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 15 affected / 436 at risk

Adverse event: Apgar score low
Serious: no
Organ System: Investigations
Frequency: 10 affected / 436 at risk