Study: NCT02883673

Adverse event: Endometritis
Serious: yes
Organ System: Infections and infestations
Notes: Endometritis
Frequency: 3 affected / 106 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Anemia
Frequency: 3 affected / 106 at risk

Adverse event: Anemia leading to hysterectomy
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Anemia leading to hysterectomy
Frequency: 1 affected / 106 at risk

Adverse event: Anemia and tachycardia and hypotension
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Anemia and tachycardia and hypotension
Frequency: 1 affected / 106 at risk

Adverse event: Continued bleeding due to undiscovered retained placenta
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Continued bleeding due to undiscovered retained placenta
Frequency: 1 affected / 106 at risk

Adverse event: Hypotension with complaint of dyspnea and nausea
Serious: yes
Organ System: Cardiac disorders
Notes: Hypotension with complaint of dyspnea and nausea
Frequency: 1 affected / 106 at risk

Adverse event: Pregnancy related hypertension
Serious: yes
Organ System: Cardiac disorders
Notes: Pregnancy related hypertension
Frequency: 1 affected / 106 at risk

Adverse event: C-section incision repair bleed
Serious: yes
Organ System: Surgical and medical procedures
Notes: C-section incision repair bleed
Frequency: 1 affected / 106 at risk

Adverse event: Constipation and hemorrhoid
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Constipation and hemorrhoid
Frequency: 1 affected / 106 at risk

Adverse event: Laceration of cervix during difficult amniotomy
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Laceration of cervix during difficult amniotomy
Frequency: 1 affected / 106 at risk

Adverse event: Renal tubular necrosis
Serious: yes
Organ System: Renal and urinary disorders
Notes: Acute tubular necrosis
Frequency: 3 affected / 106 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary edema
Frequency: 1 affected / 106 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath
Frequency: 1 affected / 106 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anemia
Frequency: 15 affected / 106 at risk

Adverse event: Anemia with tachycardia
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Anemia with tachycardia
Frequency: 1 affected / 106 at risk

Adverse event: Lower uterine segment clot requiring removal
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Lower uterine segment clot requiring removal
Frequency: 1 affected / 106 at risk

Adverse event: Passed clots at 4 weeks postpartum with pain
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Passed clots at 4 weeks postpartum with pain
Frequency: 1 affected / 106 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Pretibial edema
Frequency: 1 affected / 106 at risk

Adverse event: Chest pain, SOB, diplopia, nausea without lab evidence of MI resolved without sequalae
Serious: no
Organ System: Cardiac disorders
Notes: Chest pain, SOB, diplopia, nausea without lab evidence of MI resolved without sequalae
Frequency: 1 affected / 106 at risk

Adverse event: Pregnancy related hypertension
Serious: no
Organ System: Cardiac disorders
Notes: Pregnancy related hypertension
Frequency: 2 affected / 106 at risk

Adverse event: Cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cellulitis
Frequency: 1 affected / 106 at risk

Adverse event: Cellulitis with yeast
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Cellulitis with yeast
Frequency: 1 affected / 106 at risk

Adverse event: labial cyst
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: labial cyst
Frequency: 2 affected / 106 at risk

Adverse event: Leg rash associated with medication for hypertension
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Leg rash associated with medication for hypertension
Frequency: 1 affected / 106 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Constipation
Frequency: 2 affected / 106 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Dyspepsia
Frequency: 1 affected / 106 at risk

Adverse event: Hemorrhoid
Serious: no
Organ System: Gastrointestinal disorders
Notes: Hemorrhoid
Frequency: 1 affected / 106 at risk

Adverse event: Presumed endometritis
Serious: no
Organ System: Infections and infestations
Notes: Presumed endometritis
Frequency: 1 affected / 106 at risk

Adverse event: Presumed endometritis with pre-existing chorioamnionitis
Serious: no
Organ System: Infections and infestations
Notes: Presumed endometritis with pre-existing chorioamnionitis
Frequency: 1 affected / 106 at risk

Adverse event: upper respiratory tract influenza
Serious: no
Organ System: Infections and infestations
Notes: upper respiratory tract influenza
Frequency: 1 affected / 106 at risk

Adverse event: Presumed endometritis with leukocytosis
Serious: no
Organ System: Infections and infestations
Notes: Presumed endometritis with leukocytosis
Frequency: 1 affected / 106 at risk

Adverse event: Bacterial vaginosis
Serious: no
Organ System: Infections and infestations
Notes: bacterial vaginosis
Frequency: 1 affected / 106 at risk

Adverse event: Chlamydia
Serious: no
Organ System: Infections and infestations
Notes: Chlamydia
Frequency: 1 affected / 106 at risk

Adverse event: Endometritis
Serious: no
Organ System: Infections and infestations
Notes: Endometritis
Frequency: 1 affected / 106 at risk

Adverse event: Mastitis
Serious: no
Organ System: Infections and infestations
Notes: Mastitis
Frequency: 1 affected / 106 at risk

Adverse event: Uncomplicated urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: Uncomplicated urinary tract infection
Frequency: 2 affected / 106 at risk

Adverse event: Vulvovaginal mycotic infection
Serious: no
Organ System: Infections and infestations
Notes: Vaginal yeast
Frequency: 1 affected / 106 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: Migraine headache
Frequency: 1 affected / 106 at risk

Adverse event: Spinal headache
Serious: no
Organ System: Nervous system disorders
Notes: Spinal headache
Frequency: 1 affected / 106 at risk

Adverse event: Vaginal pain and light bleeding from pre-existing laceration
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Vaginal pain and light bleeding from pre-existing laceration
Frequency: 1 affected / 106 at risk

Adverse event: Breast rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Breast rash
Frequency: 1 affected / 106 at risk

Adverse event: Breast pain possibly blocked duct
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Breast pain possibly blocked duct
Frequency: 1 affected / 106 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Dysuria
Frequency: 1 affected / 106 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 1 affected / 106 at risk

Adverse event: Pelvic and perineal pain
Serious: no
Organ System: Reproductive system and breast disorders
Notes: Pelvic and perineal pain
Frequency: 1 affected / 106 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: Anxiety
Frequency: 2 affected / 106 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Notes: Depression
Frequency: 2 affected / 106 at risk

Adverse event: Depression, anxiety, PTSD
Serious: no
Organ System: Psychiatric disorders
Notes: Depression, anxiety, PTSD
Frequency: 1 affected / 106 at risk

Adverse event: Renal tubular necrosis
Serious: no
Organ System: Renal and urinary disorders
Notes: acute tubular necrosis
Frequency: 1 affected / 106 at risk

Adverse event: Hypoxia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Hypoxia
Frequency: 1 affected / 106 at risk

Adverse event: Pulmonary oedema
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Pulmonary edema
Frequency: 1 affected / 106 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Shortness of breath
Frequency: 1 affected / 106 at risk

Adverse event: Disruption of laceration repair
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Disruption of laceration repair
Frequency: 1 affected / 106 at risk