Study: NCT02438371

Adverse event: Death (neonatal)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Admission to NICU (neonatal)
Serious: yes
Organ System: General disorders
Frequency: 16 affected / 26 at risk

Adverse event: Intraventricular Hemorrhage (neonatal)
Serious: yes
Organ System: Vascular disorders
Frequency: 3 affected / 26 at risk

Adverse event: Necrotizing Enterocolitis (neonatal)
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 26 at risk

Adverse event: Culture-Positive Sepsis (neonatal)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 26 at risk

Adverse event: Received Mechanical Ventilation (neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 26 at risk

Adverse event: Received Continuous Positive Airway Pressure (CPAP) (neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 26 at risk

Adverse event: Respiratory distress syndrome (RDS) (neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 26 at risk

Adverse event: Retinopathy of prematurity (neonatal)
Serious: yes
Organ System: Eye disorders
Frequency: 4 affected / 26 at risk

Adverse event: Received Blood Transfusion (maternal)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea (maternal)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

Adverse event: Acid Reflux (maternal)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypotension (maternal)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Tachycardia (maternal)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 20 at risk

Adverse event: Clinical Chorioamnionitis (maternal)
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Preterm Premature Rupture of Membranes (PPROM) (maternal)
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 20 at risk

Adverse event: Preeclampsia (maternal)
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 20 at risk

Adverse event: Death (neonatal)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 23 at risk

Adverse event: Admission to NICU (neonatal)
Serious: yes
Organ System: General disorders
Frequency: 13 affected / 23 at risk

Adverse event: Intraventricular Hemorrhage (neonatal)
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 23 at risk

Adverse event: Culture-Positive Sepsis (neonatal)
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 23 at risk

Adverse event: Seizures (neonatal)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk

Adverse event: Received Mechanical Ventilation (neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 23 at risk

Adverse event: Received Continuous Positive Airway Pressure (CPAP) (neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 23 at risk

Adverse event: Respiratory distress syndrome (RDS) (neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 23 at risk

Adverse event: Retinopathy of prematurity (neonatal)
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 23 at risk

Adverse event: Received Blood Transfusion (maternal)
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Headache (maternal)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

Adverse event: Acid Reflux (maternal)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 22 at risk

Adverse event: Hypotension (maternal)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 22 at risk

Adverse event: Tachycardia (maternal)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 22 at risk

Adverse event: Preterm Premature Rupture of Membranes (PPROM) (maternal)
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 22 at risk

Adverse event: Preeclampsia (maternal)
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 22 at risk