Different Medications to Induce Labor (BLOOM)

Mount Sinai Health System

Status and phase: Enrolling; Phase 3

Conditions: Labor; Pregnancy

Treatments: Drug: Misoprostol; Drug: Pitocin

Study type: Interventional

Funder types: Other

Identifiers

NCT06259097

STUDY-24-00118

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

Misoprostol and Pitocin

Active Comparator group

Description:

Patient receives misoprostol and foley catheter for initial induction of labor, followed by pitocin later on.

Treatment:

Drug: Pitocin

Drug: Misoprostol

Pitocin only

Active Comparator group

Description:

Patient receives pitocin and foley catheter for initial induction of labor, followed by more pitocin later on.

Treatment:

Drug: Pitocin