Induction of Labor
Conditions
Keywords
Induction of Labor, Pitocin, Oxytocin, Foley bulb
Brief summary
This study is considering current standard oxytocin dosing regimen in combination with Foley bulb for cervical ripening is associated with improved outcomes including greater percentage of women delivered within or less than 24 hours. The investigators will also assess other maternal and neonatal outcomes including risk of infection (i.e. chorioamnionitis), bleeding, uterine atony, cesarean delivery and use of regional analgesia. Participants will be randomly assigned to one of the 2 arms of the study: use of oxytocin or no oxytocin while the Foley bulb is in place. As part of standard of care for inductions, Foley bulbs will be placed for all participants. Study participants who are randomly assigned to the use of oxytocin will receive oxytocin at the time the Foley bulb is placed. Study participants randomly assigned to no oxytocin will receive the oxytocin once the Foley bulb is removed. After delivery, information will be collected from participant's chart on the outcome of pregnancy such as gestational age at delivery, type of delivery (vaginal or cesarean section), and baby's outcome (such as birth weight, APGAR scores, and any complications).
Detailed description
Currently there is a paucity of literature to determine the efficacy of use of Pitocin during Foley placement, a single study has been published which suggests that the induction to delivery time is shortened in multiparas, but not in nulliparas. This study was not specifically powered to assess nulliparas as well, without increased risk.
Interventions
DRUGOxytocin
Use of oxytocin while the Foley bulb is in place
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* women at \> 24 weeks gestation * a non-anomalous, singleton fetus in a vertex presentation
Exclusion criteria
* history of prior uterine surgery such as cesarean section or myomectomy * unexplained vaginal bleeding * latex allergy * contraindication to vaginal delivery (i.e. placenta previa, vasa previa, active vaginal bleeding, macrosomia etc)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| induction time to delivery | Time from induction to delivery, average 12-28 hours | The time from induction to delivery will be starting from the time the first induction agent is used on the patient until the official time of birth of the neonate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mode of delivery | average of 12-28 hours from induction until official time of birth | The mode of delivery is ascertained from the delivery summary as either spontaneous vaginal delivery, cesarean delivery, vacuum assisted vaginal delivery, or forcep assisted vaginal delivery. |
| estimated blood loss | average of 12-28 hours from induction until official time of birth | — |
| uterine atony | average of 12-28 hours from induction until official time of birth | uterine atony is assessed by both provider report and/or the use of uterotonics as indicated by the chart. |
| chorioamnionitis | average of 12-28 hours from induction until official time of birth | Chorioamnionitis is ascertained from provider report as fever with either maternal/fetal tachycardia, fundal tenderness, or foul smelling fluid while the patient is in labor. |
| neonatal birthweight | average of 12-28 hours from induction until official time of birth | — |
Countries
United States
Outcome results
None listed