Study: NCT01144416

Adverse event: Foreign body
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 692 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 692 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 692 at risk

Adverse event: Post procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 61 affected / 692 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 98 affected / 692 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 73 affected / 692 at risk

Adverse event: Abortion missed
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 29 affected / 692 at risk

Adverse event: Pelvic discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 52 affected / 692 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 692 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 692 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 692 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 692 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 692 at risk

Adverse event: Morning sickness
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 25 affected / 692 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 692 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 692 at risk

Adverse event: Cardiomyopathy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 698 at risk

Adverse event: Abortion infected
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 698 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 698 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 698 at risk

Adverse event: Cerebral ischaemia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 698 at risk

Adverse event: Hemianopia
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 698 at risk

Adverse event: Abortion missed
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 698 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 698 at risk

Adverse event: Ectopic pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 8 affected / 698 at risk

Adverse event: Ovarian hyperstimulation syndrome
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 698 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 698 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 33 affected / 698 at risk

Adverse event: Post procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 69 affected / 698 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 83 affected / 698 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 73 affected / 698 at risk

Adverse event: Abortion missed
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 39 affected / 698 at risk

Adverse event: Pelvic discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 57 affected / 698 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 698 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 698 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 698 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 698 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 698 at risk

Adverse event: Morning sickness
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 31 affected / 698 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 698 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 698 at risk

Adverse event: Abortion missed
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 154 at risk

Adverse event: Thrombocytopenia neonatal
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 154 at risk

Adverse event: Bradycardia neonatal
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 154 at risk

Adverse event: Foetal heart rate deceleration abnormality
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 154 at risk

Adverse event: Ventricular hypertrophy
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 154 at risk

Adverse event: Tethered oral tissue
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 154 at risk

Adverse event: Chordee
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Congenital aortic anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Congenital cardiovascular anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 154 at risk

Adverse event: Congenital genital malformation male
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Congenital hypothyroidism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Congenital melanocytic naevus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Congenital pyelocaliectasis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Congenital torticollis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Dacryostenosis congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Exomphalos
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 5 affected / 154 at risk

Adverse event: Fallot's tetralogy
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Foetal cystic hygroma
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 154 at risk

Adverse event: Haemangioma congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 154 at risk

Adverse event: High arched palate
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Developmental hip dysplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 154 at risk

Adverse event: Hooded prepuce
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Hydrocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Hypoplastic left heart syndrome
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Intestinal malrotation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Laryngomalacia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 154 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 154 at risk

Adverse event: Phimosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Plagiocephaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 154 at risk

Adverse event: Respiratory tract malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Talipes
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Telangiectasia congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Trisomy 18
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 154 at risk

Adverse event: Trisomy 21
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 154 at risk

Adverse event: Trisomy 22
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 154 at risk

Adverse event: Retinal detachment
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 154 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Temperature regulation disorder
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 154 at risk

Adverse event: Paronychia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 154 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 154 at risk

Adverse event: Post procedural haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 154 at risk

Adverse event: Foetal heart rate abnormal
Serious: yes
Organ System: Investigations
Frequency: 6 affected / 154 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 154 at risk

Adverse event: Selective eating disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 154 at risk

Adverse event: Hypoglycaemia neonatal
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 154 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 154 at risk

Adverse event: Retrognathia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 154 at risk

Adverse event: Arrested labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 16 affected / 154 at risk

Adverse event: Breech presentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 12 affected / 154 at risk

Adverse event: Cephalo-pelvic disproportion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 154 at risk

Adverse event: Cervical incompetence
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: Discordant twin
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: Failed induction of labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 154 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 154 at risk

Adverse event: Foetal macrosomia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 154 at risk

Adverse event: Gestational diabetes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 154 at risk

Adverse event: Haemorrhage in pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: HELLP syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 154 at risk

Adverse event: Low birth weight baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: Multiple pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: Peripartum cardiomyopathy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: Placenta praevia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 154 at risk

Adverse event: Placenta praevia haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 154 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 154 at risk

Adverse event: Pregnancy with advanced maternal age
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 154 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 154 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 154 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: Previous caesarean section
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 154 at risk

Adverse event: Prolonged labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: Small for dates baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 154 at risk

Adverse event: Transverse presentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 154 at risk

Adverse event: Twin pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 10 affected / 154 at risk

Adverse event: Umbilical cord around neck
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: Uterine cervical laceration
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 154 at risk

Adverse event: Proteinuria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 154 at risk

Adverse event: Cervix oedema
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 154 at risk

Adverse event: Pelvic organ prolapse
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 154 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 154 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Transient tachypnoea of the newborn
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 154 at risk

Adverse event: Abortion induced
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 154 at risk

Adverse event: Caesarean section
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 8 affected / 154 at risk

Adverse event: Myomectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 154 at risk

Adverse event: Selective abortion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 154 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 154 at risk

Adverse event: Post procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 154 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 13 affected / 154 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 154 at risk

Adverse event: Pelvic discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 154 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 154 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 154 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 154 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 154 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 154 at risk

Adverse event: Perineal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 8 affected / 154 at risk

Adverse event: Afterbirth pain
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 154 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 154 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 31 affected / 154 at risk

Adverse event: Premature baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 14 affected / 154 at risk

Adverse event: Morning sickness
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 10 affected / 154 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 154 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 154 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 7 affected / 154 at risk

Adverse event: Abortion missed
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 167 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 167 at risk

Adverse event: Foetal heart rate deceleration abnormality
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 167 at risk

Adverse event: Accessory auricle
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Tethered oral tissue
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 6 affected / 167 at risk

Adverse event: Arnold-Chiari malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Brain malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Chordee
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Congenital cardiovascular anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Congenital central nervous system anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Congenital choroid plexus cyst
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 167 at risk

Adverse event: Polycystic liver disease
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Congenital genital malformation male
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Congenital hydronephrosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 167 at risk

Adverse event: Congenital inguinal hernia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Congenital oral malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Congenital pigmentation disorder
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 167 at risk

Adverse event: Dacryostenosis congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 4 affected / 167 at risk

Adverse event: Deafness congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Dermoid cyst
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Dysmorphism
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 167 at risk

Adverse event: Exomphalos
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 167 at risk

Adverse event: Haemangioma congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 6 affected / 167 at risk

Adverse event: Developmental hip dysplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 6 affected / 167 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Pectus excavatum
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Plagiocephaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Pulmonary artery stenosis congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Septum pellucidum agenesis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Congenital musculoskeletal disorder of skull
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Spina bifida
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Talipes
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 167 at risk

Adverse event: Trisomy 13
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Trisomy 21
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 167 at risk

Adverse event: Urachal abnormality
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 167 at risk

Adverse event: Functional gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Hyperbilirubinaemia neonatal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 167 at risk

Adverse event: Appendicitis perforated
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Endometritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 167 at risk

Adverse event: Herpes virus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 167 at risk

Adverse event: Foetal heart rate abnormal
Serious: yes
Organ System: Investigations
Frequency: 5 affected / 167 at risk

Adverse event: Foetal heart rate decreased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 167 at risk

Adverse event: Foetal non-stress test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 167 at risk

Adverse event: Selective eating disorder
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 167 at risk

Adverse event: Ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 167 at risk

Adverse event: Cerebral ventricle dilatation
Serious: yes
Organ System: Nervous system disorders
Frequency: 3 affected / 167 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 167 at risk

Adverse event: Intraventricular haemorrhage neonatal
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 167 at risk

Adverse event: Migraine with aura
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 167 at risk

Adverse event: Arrested labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 13 affected / 167 at risk

Adverse event: Breech presentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 14 affected / 167 at risk

Adverse event: Failed induction of labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 167 at risk

Adverse event: Foetal distress syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 167 at risk

Adverse event: Foetal growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 167 at risk

Adverse event: Foetal macrosomia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 167 at risk

Adverse event: Foetal malpresentation
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 167 at risk

Adverse event: Gestational hypertension
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 167 at risk

Adverse event: Haemorrhage in pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 167 at risk

Adverse event: Jaundice neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 167 at risk

Adverse event: Low birth weight baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 167 at risk

Adverse event: Meconium in amniotic fluid
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 167 at risk

Adverse event: Multiple pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 167 at risk

Adverse event: Oligohydramnios
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 167 at risk

Adverse event: Placenta praevia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 167 at risk

Adverse event: Placenta praevia haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 167 at risk

Adverse event: Postpartum haemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 167 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 167 at risk

Adverse event: Premature baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 17 affected / 167 at risk

Adverse event: Premature labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 8 affected / 167 at risk

Adverse event: Premature rupture of membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 167 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 167 at risk

Adverse event: Previous caesarean section
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 14 affected / 167 at risk

Adverse event: Prolonged pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 167 at risk

Adverse event: Retained placenta or membranes
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 167 at risk

Adverse event: Small for dates baby
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 167 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 167 at risk

Adverse event: Threatened labour
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 167 at risk

Adverse event: Twin pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 167 at risk

Adverse event: Vasa praevia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 167 at risk

Adverse event: Weight decrease neonatal
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 167 at risk

Adverse event: Bladder dysfunction
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 167 at risk

Adverse event: Cervix disorder
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 167 at risk

Adverse event: Shortened cervix
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 167 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Atelectasis neonatal
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Bronchopulmonary dysplasia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Immature respiratory system
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Infantile apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Neonatal aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 167 at risk

Adverse event: Neonatal respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 167 at risk

Adverse event: Caesarean section
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 5 affected / 167 at risk

Adverse event: Myomectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 167 at risk

Adverse event: Selective abortion
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 167 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 167 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 167 at risk

Adverse event: Post procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 167 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 18 affected / 167 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 167 at risk

Adverse event: Pelvic discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 6 affected / 167 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 167 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 167 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 167 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 167 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 167 at risk

Adverse event: Perineal injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 167 at risk

Adverse event: Afterbirth pain
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 167 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 14 affected / 167 at risk

Adverse event: Jaundice neonatal
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 27 affected / 167 at risk

Adverse event: Premature baby
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 10 affected / 167 at risk

Adverse event: Morning sickness
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 167 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 167 at risk

Adverse event: Neonatal respiratory distress syndrome
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 167 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 14 affected / 167 at risk