Study: NCT01916681

Adverse event: Amniotic cavity infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Defined by use of antibiotics during labor not for GBS+ or other known infection.
Frequency: 15 affected / 123 at risk

Adverse event: Wound infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Diagnosed on chart review by provider documenting a diagnosis of cellulitis, need for antibiotics to treat wound, wound separation, purulent discharge from wound, abscess, or need for debridement.
Frequency: 1 affected / 123 at risk

Adverse event: Maternal blood transfusion
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 123 at risk

Adverse event: Postpartum readmission
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 123 at risk

Adverse event: NICU admission
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 10 affected / 123 at risk

Adverse event: Presumed Sepsis
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 123 at risk

Adverse event: Amniotic cavity infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Defined by use of antibiotics during labor not for GBS+ or other known infection.
Frequency: 9 affected / 120 at risk

Adverse event: Endometritis
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Diagnosed and treated based on maternal fever (\>100.4) in the setting of either (1) fundal tenderness or (2) maternal tachycardia
Frequency: 1 affected / 120 at risk

Adverse event: Wound infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Diagnosed on chart review by provider documenting a diagnosis of cellulitis, need for antibiotics to treat wound, wound separation, purulent discharge from wound, abscess, or need for debridement.
Frequency: 1 affected / 120 at risk

Adverse event: Maternal blood transfusion
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 120 at risk

Adverse event: Postpartum readmission
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 120 at risk

Adverse event: NICU admission
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 120 at risk

Adverse event: Severe respiratory distress
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Intubation and mechanical ventilation for a minimum of 12 hours.
Frequency: 1 affected / 120 at risk

Adverse event: Presumed Sepsis
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 120 at risk

Adverse event: Amniotic cavity infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Defined by use of antibiotics during labor not for GBS+ or other known infection.
Frequency: 17 affected / 123 at risk

Adverse event: Wound infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Diagnosed on chart review by provider documenting a diagnosis of cellulitis, need for antibiotics to treat wound, wound separation, purulent discharge from wound, abscess, or need for debridement.
Frequency: 1 affected / 123 at risk

Adverse event: Maternal blood transfusion
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 123 at risk

Adverse event: Postpartum readmission
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 123 at risk

Adverse event: NICU admission
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 17 affected / 123 at risk

Adverse event: Severe respiratory distress
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Intubation and mechanical ventilation for a minimum of 12 hours.
Frequency: 2 affected / 123 at risk

Adverse event: Presumed Sepsis
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 123 at risk

Adverse event: Amniotic cavity infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Defined by use of antibiotics during labor not for GBS+ or other known infection.
Frequency: 20 affected / 125 at risk

Adverse event: Wound infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Diagnosed on chart review by provider documenting a diagnosis of cellulitis, need for antibiotics to treat wound, wound separation, purulent discharge from wound, abscess, or need for debridement.
Frequency: 3 affected / 125 at risk

Adverse event: Maternal blood transfusion
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 125 at risk

Adverse event: Postpartum readmission
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 7 affected / 125 at risk

Adverse event: NICU admission
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 11 affected / 125 at risk

Adverse event: Presumed Sepsis
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 125 at risk