Study: NCT01004029

Adverse event: Cholestasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 578 at risk

Adverse event: Endometritis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 578 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 578 at risk

Adverse event: Placental insufficiency
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 578 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 578 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 578 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 578 at risk

Adverse event: Oedema peripheral
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 578 at risk

Adverse event: Clostridial infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 578 at risk

Adverse event: Endometritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 578 at risk

Adverse event: Puerperal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 578 at risk

Adverse event: Kidney infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 578 at risk

Adverse event: Pelvic abcess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 578 at risk

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 578 at risk

Adverse event: Bladder injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 578 at risk

Adverse event: Incision site haematoma
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 578 at risk

Adverse event: Traumatic pain
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 578 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 578 at risk

Adverse event: Haemorrhage in pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 578 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 578 at risk

Adverse event: Pulmonary embolism
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 578 at risk

Adverse event: Deep vein thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 578 at risk

Adverse event: Incision site haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 578 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 56 affected / 578 at risk

Adverse event: Anaemia of pregnancy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 18 affected / 578 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 27 affected / 578 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 578 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 578 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 578 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 578 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 26 affected / 578 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 578 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 24 affected / 578 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 23 affected / 578 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 11 affected / 578 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 578 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 578 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 578 at risk

Adverse event: Bacterial vulvovaginitis
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 578 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 578 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 21 affected / 578 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 20 affected / 578 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 578 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 578 at risk

Adverse event: Afterbirth pain
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 24 affected / 578 at risk

Adverse event: Cervical incompetence
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 16 affected / 578 at risk

Adverse event: Placental disorder
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 578 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 578 at risk

Adverse event: Shortened cervix
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 15 affected / 578 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 13 affected / 578 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 22 affected / 578 at risk

Adverse event: Endometritis
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1128 at risk

Adverse event: Escherichia sepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1128 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1128 at risk

Adverse event: Placental insufficiency
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 1128 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1128 at risk

Adverse event: Premature separation of placenta
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 1128 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1128 at risk

Adverse event: Wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1128 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1128 at risk

Adverse event: Iron deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1128 at risk

Adverse event: Pancreatitis relapsing
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1128 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1128 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1128 at risk

Adverse event: Cholestasis of pregnancy
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1128 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1128 at risk

Adverse event: Choriaoamnionitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1128 at risk

Adverse event: Endometritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1128 at risk

Adverse event: Mastitis postpartum
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1128 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1128 at risk

Adverse event: Abdominal wound dehiscence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1128 at risk

Adverse event: Incision site haemorrhage
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1128 at risk

Adverse event: Biopsy chorionic villous abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1128 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1128 at risk

Adverse event: Central nervous system inflammation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1128 at risk

Adverse event: Confusional state
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1128 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1128 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1128 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1128 at risk

Adverse event: Uterine haemorrhage
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 1128 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1128 at risk

Adverse event: Scar
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1128 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 104 affected / 1128 at risk

Adverse event: Anaemia of pregnancy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 30 affected / 1128 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 40 affected / 1128 at risk

Adverse event: Abdominal pain lower
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 1128 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 38 affected / 1128 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 1128 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 37 affected / 1128 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 55 affected / 1128 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 1128 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 36 affected / 1128 at risk

Adverse event: Injection site pruritus
Serious: no
Organ System: General disorders
Frequency: 42 affected / 1128 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 25 affected / 1128 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 39 affected / 1128 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 44 affected / 1128 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Frequency: 41 affected / 1128 at risk

Adverse event: Bacterial vulvovaginitis
Serious: no
Organ System: Infections and infestations
Frequency: 35 affected / 1128 at risk

Adverse event: Vulvovaginal candidiasis
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 1128 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 1128 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 50 affected / 1128 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 1128 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 68 affected / 1128 at risk

Adverse event: Afterbirth pain
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 48 affected / 1128 at risk

Adverse event: Cervical incompetence
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 34 affected / 1128 at risk

Adverse event: Placental disorder
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 28 affected / 1128 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 36 affected / 1128 at risk

Adverse event: Shortened cervix
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 18 affected / 1128 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 1128 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 29 affected / 1128 at risk