Labor, Pregnancy
Conditions
Brief summary
This is a randomized controlled trial examining whether the use of misoprostol or pitocin, in combination with a foley catheter, is more effective at inducing labor in patients with a gravid BMI that is considered obese.
Detailed description
This randomized controlled trial will include patients with a BMI greater than 30 at the time of admission for their induction of labor. Patients will be randomized to either misoprostol or Pitocin to begin induction of labor, alongside the standard foley catheter, and the primary outcome of interest will be length of time from start of induction until delivery.
Interventions
DRUGMisoprostol
25 mcg vaginally every 6 hours
DRUGPitocin
3-6 mL intravenously every hour
Sponsors
Icahn School of Medicine at Mount Sinai
Bronx Care Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Pregnant patient presenting to labor \& delivery for induction of labor with a BMI \> = 30
Exclusion criteria
\- Pregnant patient presenting to labor \& delivery for induction of labor with BMI \< 30
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time from induction to delivery | start of induction until delivery | Simple measure calculating time from start of induction until delivery of neonate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Delivery outcome | at delivery | Simple determination whether patient had a vaginal delivery or delivered by cesarean section. |
Countries
United States
Contacts
STUDY_DIRECTORNicola F Tavella, MPH
Icahn School of Medicine at Mount Sinai
PRINCIPAL_INVESTIGATORAngela Bianco, MD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed