Study: NCT02901626

Adverse event: Neonatal ventricular septal defect
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 280 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 280 at risk

Adverse event: Hyperbilirubinemia and weight loss
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 280 at risk

Adverse event: Meconium aspiration syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 280 at risk

Adverse event: Respiratory syncytial virus/ bronchiolitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 280 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 280 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 280 at risk

Adverse event: Ambiguous genitalia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 280 at risk

Adverse event: Craniosynostosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 280 at risk

Adverse event: Hypospadias
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 280 at risk

Adverse event: Post-partum hemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 280 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 280 at risk

Adverse event: Disseminated herpes simplex virus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 280 at risk

Adverse event: Trisomy 21
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 280 at risk

Adverse event: Vaginal fluid leakage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 26 affected / 280 at risk

Adverse event: Lower abdominal/pelvic pain
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 79 affected / 280 at risk

Adverse event: Lower abdominal/pelvic pressure
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 103 affected / 280 at risk

Adverse event: Urinary change in frequency and incontinence
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 53 affected / 280 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 14 affected / 280 at risk

Adverse event: Vaginal burning
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 21 affected / 280 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 201 affected / 280 at risk

Adverse event: Vaginal discomfort/soreness
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 101 affected / 280 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 45 affected / 280 at risk

Adverse event: Vaginal odour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 54 affected / 280 at risk

Adverse event: Hypertension Management
Serious: yes
Organ System: Vascular disorders
Notes: hospitalized for adjustment of BP meds after not taking meds as prescribed
Frequency: 1 affected / 264 at risk

Adverse event: Neonatal ventricular septal defect
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 264 at risk

Adverse event: Neonatal intestinal failure
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Glucoregulation in the setting of steroid administration
Serious: yes
Organ System: Endocrine disorders
Notes: hospitalized for management of gestational diabetes (along with antenatal corticosteroids)
Frequency: 1 affected / 264 at risk

Adverse event: COVID-19
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: maternal COVID-19 infection
Frequency: 1 affected / 264 at risk

Adverse event: Hospital-based pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 264 at risk

Adverse event: Neonatal central nervous system malformation
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Post-partum hemorrhage
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 264 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 264 at risk

Adverse event: Neonatal amputation
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Polydactyly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 264 at risk

Adverse event: Auditory hallucination
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 264 at risk

Adverse event: Chronic multifocal osteomyelitis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 264 at risk

Adverse event: Neonatal CN6 Palsy
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Erb-Duchenne Palsy
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Neonatal hematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Pelvic haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 264 at risk

Adverse event: Necrotising colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 264 at risk

Adverse event: Vaginal fluid leakage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 264 at risk

Adverse event: Lower abdominal/pelvic pain
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 80 affected / 264 at risk

Adverse event: Lower abdominal/pelvic pressure
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 89 affected / 264 at risk

Adverse event: Urinary change in frequency and incontinence
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 37 affected / 264 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 264 at risk

Adverse event: Vaginal burning
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 16 affected / 264 at risk

Adverse event: Vaginal discharge
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 160 affected / 264 at risk

Adverse event: Vaginal discomfort/soreness
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 69 affected / 264 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 26 affected / 264 at risk

Adverse event: Vaginal odour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 25 affected / 264 at risk