Study: NCT00828711

Adverse event: Ankyloglossia congenital *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 118 at risk

Adverse event: Syndactyly *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 118 at risk

Adverse event: Dacryostenosis congenital *
Serious: yes
Organ System: Eye disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 118 at risk

Adverse event: Fever neonatal *
Serious: yes
Organ System: General disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 118 at risk

Adverse event: Herpes simplex *
Serious: yes
Organ System: Infections and infestations
Notes: \* Neonatal Event
Frequency: 1 affected / 118 at risk

Adverse event: Arterial injury #
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: # Postpartum Event
Frequency: 1 affected / 118 at risk

Adverse event: Post procedural haemorrhage #
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: # Postpartum Event
Frequency: 1 affected / 118 at risk

Adverse event: Abnormal labour affecting foetus +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 1 affected / 118 at risk

Adverse event: Arrested labour +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 15 affected / 118 at risk

Adverse event: Chorioamnionitis +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 2 affected / 118 at risk

Adverse event: Drug withdrawal syndrome neonatal +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 1 affected / 118 at risk

Adverse event: Foetal heart rate disorder +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 11 affected / 118 at risk

Adverse event: Hyperbilirubinaemia neonatal *
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 3 affected / 118 at risk

Adverse event: Hypoglycaemia neonatal *
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 1 affected / 118 at risk

Adverse event: Postpartum haemorrhage #
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: # Postpartum Event
Frequency: 1 affected / 118 at risk

Adverse event: Pre-eclampsia #
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: # Postpartum Event
Frequency: 1 affected / 118 at risk

Adverse event: Renal failure acute #
Serious: yes
Organ System: Renal and urinary disorders
Notes: # Postpartum Event
Frequency: 1 affected / 118 at risk

Adverse event: Penis disorder *
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 118 at risk

Adverse event: Vaginal haematoma #
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: # Postpartum Event
Frequency: 1 affected / 118 at risk

Adverse event: Vulval haematoma +
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: + Intrapartum Event
Frequency: 1 affected / 118 at risk

Adverse event: Neonatal hypoxia *
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 118 at risk

Adverse event: Infection prophylaxis *
Serious: yes
Organ System: Surgical and medical procedures
Notes: \* Neonatal Event
Frequency: 2 affected / 118 at risk

Adverse event: Anaemia #
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: # Postpartum Event
Frequency: 10 affected / 118 at risk

Adverse event: Abnormal labour affecting foetus +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 8 affected / 118 at risk

Adverse event: Caput succedaneum *
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 4 affected / 118 at risk

Adverse event: Chorioamnionitis +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 5 affected / 118 at risk

Adverse event: Foetal heart rate disorder +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 67 affected / 118 at risk

Adverse event: Hyperbilirubinaemia neonatal *
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 9 affected / 118 at risk

Adverse event: Meconium in amniotic fluid +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 15 affected / 118 at risk

Adverse event: Postpartum haemorrhage #
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: # Postpartum Event
Frequency: 4 affected / 118 at risk

Adverse event: Umbilical cord around neck *
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 14 affected / 118 at risk

Adverse event: Uterine contractions abnormal +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 23 affected / 118 at risk

Adverse event: Uterine hypertonus +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 4 affected / 118 at risk

Adverse event: Uterine atony #
Serious: no
Organ System: Reproductive system and breast disorders
Notes: # Postpartum Event
Frequency: 5 affected / 118 at risk

Adverse event: Neonatal respiratory distress syndrome *
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \* Neonatal Event
Frequency: 6 affected / 118 at risk

Adverse event: Polydactyly *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 3 affected / 125 at risk

Adverse event: Congenital syphilis *
Serious: yes
Organ System: Infections and infestations
Notes: \* Neonatal Event
Frequency: 1 affected / 125 at risk

Adverse event: Endometritis #
Serious: yes
Organ System: Infections and infestations
Notes: # Postpartum Event
Frequency: 1 affected / 125 at risk

Adverse event: Urine cannabinoids increased +
Serious: yes
Organ System: Investigations
Notes: + Intrapartum Event
Frequency: 1 affected / 125 at risk

Adverse event: Dehydration *
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 125 at risk

Adverse event: Feeding disorder neonatal *
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: \* Neonatal Event
Frequency: 2 affected / 125 at risk

Adverse event: Arrested labour +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 16 affected / 125 at risk

Adverse event: Foetal heart rate disorder +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 12 affected / 125 at risk

Adverse event: Foetal malpresentation +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 1 affected / 125 at risk

Adverse event: Hyperbilirubinaemia neonatal *
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 7 affected / 125 at risk

Adverse event: Hypoglycaemia neonatal *
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 2 affected / 125 at risk

Adverse event: Neonatal disorder *
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 1 affected / 125 at risk

Adverse event: Pre-eclampsia +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 1 affected / 125 at risk

Adverse event: Puerperal pyrexia #
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: # Postpartum Event
Frequency: 1 affected / 125 at risk

Adverse event: Small for dates baby *
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 1 affected / 125 at risk

Adverse event: Pulmonary oedema #
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: # Postpartum Event
Frequency: 1 affected / 125 at risk

Adverse event: Infection prophylaxis *
Serious: yes
Organ System: Surgical and medical procedures
Notes: \* Neonatal Event
Frequency: 2 affected / 125 at risk

Adverse event: Anaemia #
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: # Postpartum Event
Frequency: 8 affected / 125 at risk

Adverse event: Abnormal labour affecting foetus +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 12 affected / 125 at risk

Adverse event: Caput succedaneum *
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 5 affected / 125 at risk

Adverse event: Chorioamnionitis +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 7 affected / 125 at risk

Adverse event: Foetal heart rate disorder +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 62 affected / 125 at risk

Adverse event: Hyperbilirubinaemia neonatal *
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 6 affected / 125 at risk

Adverse event: Meconium in amniotic fluid +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 13 affected / 125 at risk

Adverse event: Postpartum haemorrhage #
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: # Postpartum Event
Frequency: 5 affected / 125 at risk

Adverse event: Umbilical cord around neck *
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 11 affected / 125 at risk

Adverse event: Uterine contractions abnormal +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 32 affected / 125 at risk

Adverse event: Uterine hypertonus +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 7 affected / 125 at risk

Adverse event: Uterine atony #
Serious: no
Organ System: Reproductive system and breast disorders
Notes: # Postpartum Event
Frequency: 9 affected / 125 at risk

Adverse event: Neonatal respiratory distress syndrome *
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \* Neonatal Event
Frequency: 4 affected / 125 at risk

Adverse event: Atrial septal defect *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 131 at risk

Adverse event: Dysmorphism *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 131 at risk

Adverse event: Polydactyly *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 5 affected / 131 at risk

Adverse event: Supernumerary nipple *
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 131 at risk

Adverse event: Endometritis #
Serious: yes
Organ System: Infections and infestations
Notes: # Postpartum Event
Frequency: 1 affected / 131 at risk

Adverse event: Postoperative wound infection #
Serious: yes
Organ System: Infections and infestations
Notes: # Postpartum Event
Frequency: 1 affected / 131 at risk

Adverse event: Medical observation *
Serious: yes
Organ System: Investigations
Notes: \* Neonatal Event
Frequency: 1 affected / 131 at risk

Adverse event: Feeding disorder neonatal *
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 131 at risk

Adverse event: Haemorrhage intracranial *
Serious: yes
Organ System: Nervous system disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 131 at risk

Adverse event: Hydrocephalus *
Serious: yes
Organ System: Nervous system disorders
Notes: \* Neonatal Event
Frequency: 1 affected / 131 at risk

Adverse event: Arrested labour +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 11 affected / 131 at risk

Adverse event: Drug withdrawal syndrome neonatal +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 2 affected / 131 at risk

Adverse event: Foetal heart rate disorder +
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 18 affected / 131 at risk

Adverse event: Hyperbilirubinaemia neonatal *
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 6 affected / 131 at risk

Adverse event: Hypoglycaemia neonatal *
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 2 affected / 131 at risk

Adverse event: Uterine cervical laceration during labour #
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: # Postpartum Event
Frequency: 1 affected / 131 at risk

Adverse event: Hypertension #
Serious: yes
Organ System: Vascular disorders
Notes: # Postpartum Event
Frequency: 1 affected / 131 at risk

Adverse event: Anaemia #
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: # Postpartum Event
Frequency: 11 affected / 131 at risk

Adverse event: Abnormal labour affecting foetus +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 16 affected / 131 at risk

Adverse event: Caput succedaneum *
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 7 affected / 131 at risk

Adverse event: Chorioamnionitis +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 2 affected / 131 at risk

Adverse event: Foetal heart rate disorder +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 57 affected / 131 at risk

Adverse event: Hyperbilirubinaemia neonatal *
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 10 affected / 131 at risk

Adverse event: Meconium in amniotic fluid +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 22 affected / 131 at risk

Adverse event: Postpartum haemorrhage #
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: # Postpartum Event
Frequency: 8 affected / 131 at risk

Adverse event: Umbilical cord around neck *
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: \* Neonatal Event
Frequency: 22 affected / 131 at risk

Adverse event: Uterine contractions abnormal +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 54 affected / 131 at risk

Adverse event: Uterine hypertonus +
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: + Intrapartum Event
Frequency: 9 affected / 131 at risk

Adverse event: Uterine atony #
Serious: no
Organ System: Reproductive system and breast disorders
Notes: # Postpartum Event
Frequency: 6 affected / 131 at risk

Adverse event: Neonatal respiratory distress syndrome *
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: \* Neonatal Event
Frequency: 5 affected / 131 at risk