Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Time from hospital admission to delivery of the newborn |
The primary outcome is to determine if there is a difference in the time from admission to delivery for those who receive transcervical foley balloon in the clinic the day before induction compared to those who get vaginal misoprostol in the hospital on the day of the induction |
From hospital admission until delivery of the newborn |
|
| Secondary |
Chorioamnionitis/endometritis |
Number of participants with fever, increased white blood cell count or foul smelling discharge in the outpatient transcervical foley group compared to that of in the intravaginal Misoprostol group |
From hospital admission until 2 weeks postpartum |
|
| Secondary |
Cesarean delivery |
Number of participants delivering via cesarean section in the outpatient transcervical foley group compared to that of in the inpatient intravaginal Misoprostol group |
From hospital admission until delivery of the newborn |
|
| Secondary |
Postpartum hemorrhage |
Number of participants with quantified blood loss greater than 1000ml in the outpatient transcervical foley group compared to that of in the inpatient intravaginal Misoprostol group |
From hospital admission until 2 weeks postpartum |
|
| Secondary |
Delivery within 24 hours of hospital admission |
To determine is if the delivery rate within 24 hours from hospital admission in the outpatient transcervical foley group is greater compared to the inpatient intravaginal Misoprostol group |
From hospital admission until delivery of the newborn |
|
| Secondary |
Total hospital length of stay |
To determine is if there is an increase risk of prolonged hospital stay in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group |
From hospital admission until discharge, assessed up to a week |
|
| Secondary |
Hospital readmission within 30 days of discharge |
To determine is if there is an increase risk of hospital readmission within 30 days of discharge in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group |
From discharge until 30 days postpartum |
|
| Secondary |
Cervical examination at the time of admission |
To determine if cervical dilation is more favorable for induction in the outpatient transcervical foley balloon compared to the inpatient intravaginal Misoprostol |
Within the first hour of hospital admission |
|
| Secondary |
Unscheduled hospital admissions or unscheduled visits to our obstetric triage unit before the time of scheduled admission |
To determine if outpatient transcervical foley balloon placement increases the unscheduled hospital admissions or unscheduled visits to our obstetric triage unit before the time of scheduled admission. |
From date of outpatient transcervical foley balloon placement until time of scheduled admission, assessed up to 12 hours |
|
| Secondary |
Frequency of acetaminophen use after randomization but before hospital admission |
To determine if outpatient transcervical foley balloon placement increases the frequency of acetaminophen use after randomization but before hospital admission |
From time of outpatient transcervical foley balloon placement until hospital admission, assessed up to 12 hours |
|
| Secondary |
Spontaneous rupture of membranes between randomization and hospital admission |
To determine if outpatient transcervical foley balloon placement increases spontaneous rupture of membranes between randomization and hospital admission |
From time of transcervical foley balloon placement until spontaneous rupture of membranes, assessed up to 12 hours |
|
| Secondary |
Duration of oxytocin infusion (in min) |
To determine if there is an increase in the duration of oxytocin infusion (in minutes) in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group |
From hospital admission until delivery of the newborn |
|
| Secondary |
Maximum oxytocin rate infused (in milliunits/min) |
To determine if there is an increase in the maximum oxytocin rate infused (in milliunits/min) in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group |
From hospital admission until delivery of the newborn |
|
| Secondary |
Duration of neuraxial anesthesia use |
To determine is if there is an increase in the duration of neuraxial anesthesia use in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group |
From hospital admission until delivery of the newborn |
|
| Secondary |
Presence of heavy vaginal bleeding before delivery |
To determine if outpatient transcervical foley balloon placement increases heavy vaginal bleeding before delivery |
From outpatient transcervical foley balloon insertion until delivery of newborn |
|
| Secondary |
Meconium-stained amniotic fluid |
To determine is if there is an increase in the rate of meconium-stained amniotic fluid in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group |
From hospital admission until delivery of the newborn |
|
| Secondary |
Time from rupture of membranes to delivery |
To determine is if there is an decreases the duration from rupture of membranes to delivery in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group |
From time of rupture of membranes until delivery of the newborn |
|
| Secondary |
Highest maternal intrapartum temperature |
To determine is if there is an increase in maternal intrapartum temperature in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group |
From hospital admission until delivery of the newborn |
|
| Secondary |
Admission white blood cell count |
To determine is if there is an increase in admission white blood cell count in the outpatient transcervical foley group compared to the inpatient intravaginal Misoprostol group |
From hospital admission until delivery of the newborn |
|
