Study: NCT02932475

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 397 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 397 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 397 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 397 at risk

Adverse event: Asthma
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 397 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Postop wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 397 at risk

Adverse event: Abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Postop wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 397 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 397 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 397 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 397 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 397 at risk

Adverse event: Impaired gastric emptying
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 397 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 397 at risk

Adverse event: Thrombotic stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 397 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 44 affected / 397 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 397 at risk

Adverse event: Preterm premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 397 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 397 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 397 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 397 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 397 at risk

Adverse event: Placenta praevia haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 397 at risk

Adverse event: Bipolar disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 397 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 397 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 397 at risk

Adverse event: Endometritis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 397 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 397 at risk

Adverse event: Influenza
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 397 at risk

Adverse event: Social circumstances
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Homeless
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Surgical and medical procedures
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Cervix cerclage procedure
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 397 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 397 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 397 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 397 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 397 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 31 affected / 397 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 8 affected / 376 at risk

Adverse event: Preterm delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 19 affected / 376 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 376 at risk

Adverse event: Haemolysis neonatal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 376 at risk

Adverse event: Nonreassuring foetal heart rate pattern
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 376 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 376 at risk

Adverse event: Persistent foetal circulation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 376 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 376 at risk

Adverse event: Cardiac septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 376 at risk

Adverse event: Laryngomalacia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 376 at risk

Adverse event: Truncus arteriosus persistent
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 376 at risk

Adverse event: Anal atresia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 376 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 376 at risk

Adverse event: Beckwith-Wiedemann syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 376 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 376 at risk

Adverse event: Hyperbilirubinaemia neonatal
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 376 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 376 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 376 at risk

Adverse event: Pulmonary malformation
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 376 at risk

Adverse event: Genitalia external ambiguous
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 376 at risk

Adverse event: Small for dates baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 376 at risk

Adverse event: Hydrops foetalis
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 376 at risk

Adverse event: Neonatal respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 376 at risk

Adverse event: Immature respiratory system
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 376 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 19 affected / 376 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 56 affected / 376 at risk

Adverse event: Jaundice
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 95 affected / 376 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 397 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 397 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 397 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 397 at risk

Adverse event: Chest Pain'
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 397 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 397 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: HELLP syndrome
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 397 at risk

Adverse event: Asthma
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 397 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 397 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 397 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Viral infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 397 at risk

Adverse event: Postop wound complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 397 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 397 at risk

Adverse event: Fall
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 397 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 7 affected / 397 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 397 at risk

Adverse event: Adrenal insufficiency
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 397 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 397 at risk

Adverse event: Osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 397 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 397 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 32 affected / 397 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 397 at risk

Adverse event: Preterm premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 397 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 397 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 397 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 397 at risk

Adverse event: Preterm delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 397 at risk

Adverse event: Psychotic disorder
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 397 at risk

Adverse event: Ovarian cyst
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 397 at risk

Adverse event: Puerperal infection
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 397 at risk

Adverse event: Shortened cervix
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 397 at risk

Adverse event: Vaginal discharge
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 397 at risk

Adverse event: Vaginal infection
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 397 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 397 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 397 at risk

Adverse event: Hypertensive emergency
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 397 at risk

Adverse event: Vaginal haemorrhage
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 397 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 397 at risk

Adverse event: Placental insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 397 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 397 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 397 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 397 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 13 affected / 370 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 370 at risk

Adverse event: Preterm delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 22 affected / 370 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 370 at risk

Adverse event: Persistent foetal circulation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 370 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 370 at risk

Adverse event: Fallot's tetralogy
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 370 at risk

Adverse event: Anal atresia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 370 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 370 at risk

Adverse event: Clavicle fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 370 at risk

Adverse event: Hyperbilirubinaemia neonatal
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 370 at risk

Adverse event: Hypocalcaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 370 at risk

Adverse event: Pulmonary hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 370 at risk

Adverse event: Jaundice
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 7 affected / 370 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 370 at risk

Adverse event: Pulmonary sequestration
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 370 at risk

Adverse event: Neonatal testicular torsion
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 370 at risk

Adverse event: Infantile apnoea
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 370 at risk

Adverse event: Hydrops foetalis
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 370 at risk

Adverse event: Neonatal respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 370 at risk

Adverse event: Immature respiratory system
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 8 affected / 370 at risk

Adverse event: Premature delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 22 affected / 370 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 54 affected / 370 at risk

Adverse event: Jaundice
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 97 affected / 370 at risk