Study: NCT00163020

Adverse event: Postpartum Hemorrhage requiring blood transfusion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 216 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Maternal Anemia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Maternal Anemia following intrapartum bleeding.
Frequency: 3 affected / 216 at risk

Adverse event: Bladder Trauma
Serious: yes
Organ System: Surgical and medical procedures
Notes: Bladder trauma during cesarean section
Frequency: 1 affected / 216 at risk

Adverse event: Neonatal Bowel Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Neonatal Cardiac Abnormalities
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Neonatal Congenital Cardiac abnormalities such as Ventricular Septal Defect (VSD), Atrial Septal Defect (ASD) ,Patent Ductus Arteriosis (PDA)
Frequency: 2 affected / 216 at risk

Adverse event: Maternal Cellulitis
Serious: yes
Organ System: Infections and infestations
Notes: maternal cellulitis at intramuscular injection site
Frequency: 2 affected / 216 at risk

Adverse event: Maternal Chorioamnionities necessitating preterm delivery
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 216 at risk

Adverse event: Neonatal Chronic Lung Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Neonatal Congenital Hypospadium
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 216 at risk

Adverse event: Congenital Abnormality
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: neonatal congenital abnormality such as club foot, cleft palate, gastroschisis, tracheal stenosis, Hydrocele, duodenal atresia, sigmoid stricture, PDA requiring ligation.
Frequency: 3 affected / 216 at risk

Adverse event: Neonatal Cranial Synostosis
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Deep Vein Thrombosis (DVT)
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 216 at risk

Adverse event: Endometritis
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 216 at risk

Adverse event: Neonatal Gastroschisis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Neonatal Intraventricular Hemorrhage (Stage III or IV)
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 216 at risk

Adverse event: Maternal HELLP Syndrome
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 216 at risk

Adverse event: Neonatal Hypoplastic Lung
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Intrauterine Fetal Demise (IUFD)
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 216 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 216 at risk

Adverse event: Neonatal Necrotizing Enterocolitis (NEC)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 216 at risk

Adverse event: Non-Occulusive Thrombus
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 216 at risk

Adverse event: Peripartum cardiomyopathy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 216 at risk

Adverse event: Neonatal pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 216 at risk

Adverse event: Neonatal pneumothorax
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 216 at risk

Adverse event: Neonatal Post Hemorrhagic Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 216 at risk

Adverse event: Neonatal Peripheral Pulmonary Stenosis
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 216 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 216 at risk

Adverse event: Prolonged Hospitalization - Maternal Urinary Retention
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 216 at risk

Adverse event: Maternal Pyelonephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 216 at risk

Adverse event: Maternal Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Compatible symptoms with diagnostic radiograph findings and positive results on blood cultures,persistent leukopenia
Frequency: 1 affected / 216 at risk

Adverse event: Neonatal Readmissions to the hospital
Serious: yes
Organ System: General disorders
Notes: Neonatal readmission to the hospital after discharge = such as temperature instability, sepsis, nutritional support and apnea
Frequency: 5 affected / 216 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Notes: diagnosed by clinical or laboratory findings
Frequency: 3 affected / 216 at risk

Adverse event: Maternal Supraventricular Tachycardia (SVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 216 at risk

Adverse event: Nectrotizing Enterocolitis (NEC)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 216 at risk

Adverse event: Uterine atony
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 216 at risk

Adverse event: Maternal Pyelonephritis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 216 at risk

Adverse event: Retained products of conception
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 216 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 216 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 29 affected / 216 at risk

Adverse event: Postpartum Hemorrhage requiring blood transfusion
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 105 at risk

Adverse event: Neonatal Chronic Lung Disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Congenital Abnormality
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: neonatal congenital abnormality such as club foot, cleft palate, gastroschisis, tracheal stenosis, Hydrocele, duodenal atresia, sigmoid stricture, PDA requiring ligation.
Frequency: 6 affected / 105 at risk

Adverse event: Neonatal Necrotizing Enterocolitis (NEC)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 105 at risk

Adverse event: Neonatal pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 105 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 105 at risk

Adverse event: Sepsis neonatal
Serious: yes
Organ System: Infections and infestations
Notes: diagnosed by clinical or laboratory findings
Frequency: 5 affected / 105 at risk

Adverse event: Maternal Supraventricular Tachycardia (SVT)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 105 at risk

Adverse event: Maternal Hematoma
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 105 at risk

Adverse event: Maternal Wound Eviceration post Cesarean Section
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 105 at risk

Adverse event: Nectrotizing Enterocolitis (NEC)
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 105 at risk

Adverse event: Meningitis neonatal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 105 at risk

Adverse event: Inguinal Hernia requiring surgical repair
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 105 at risk

Adverse event: Pulmonary oedema
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 105 at risk

Adverse event: Gestational diabetes
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 5 affected / 105 at risk

Adverse event: Pre-eclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 13 affected / 105 at risk