Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Foley OR MisO for the Management of Induction (FOR MOMI) Trial
Brief Summary: The percentage of women undergoing an induction of labor (IOL) is estimated to be 20% and continues to rise. Simultaneously, the cesarean delivery (CD) rate has continued to increase (2). Induction is a known risk factor for CD. Despite numerous studies evaluating time periods to define a failed IOL, there are no guidelines or accepted definitions of when to call an IOL failed given the incremental gain in vaginal delivery when IOL is prolonged. While decreasing the CD rate is an important primary focus in obstetrics, attention must also be paid to the overall length of labor given that prolonged labor is associated with adverse maternal and neonatal outcomes. Furthermore, a prolonged labor is associated with an increase in direct hospital costs and healthcare utilization. The use of cervical ripening agents, such as vaginal prostaglandin and mechanical dilators, has been demonstrated to reduce labor time and CD rate. In addition to specific individual agents, certain dosing and regimens for IOL and active labor have been compared to evaluate whether a particular dose or regimen can decrease the length of labor and decrease the CD rate. Most of these regimens; however, focus on individual induction agents and few have compared the efficacy of using more than one agent simultaneously. Given the associated risks of prolonged labor and limited data evaluating the use of combined cervical ripening agents, our objective is to evaluate the difference in time to delivery among women who undergo an IOL with four different methods.


Options:
A: Arm Label: FOLEY BALLOON; Type: ACTIVE_COMPARATOR; Interventions: Device: FOLEY BALLOON | Arm Label: CERVIDIL; Type: ACTIVE_COMPARATOR; Interventions: Drug: CERVIDIL (Dinoprostone) | Intervention Type: DRUG; Name: CERVIDIL (Dinoprostone); Assigned to Arm(s): CERVIDIL | Intervention Type: DEVICE; Name: FOLEY BALLOON; Assigned to Arm(s): FOLEY BALLOON
B: Arm Label: Combined approach: Foley Balloon + Vaginal Misoprostol; Type: EXPERIMENTAL; Interventions: Device: Foley Balloon + Vaginal Misoprostol | Arm Label: Single approach: Vaginal Misoprostol only; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vaginal Misoprostol | Intervention Type: DRUG; Name: Vaginal Misoprostol; Assigned to Arm(s): Single approach: Vaginal Misoprostol only | Intervention Type: DEVICE; Name: Foley Balloon + Vaginal Misoprostol; Assigned to Arm(s): Combined approach: Foley Balloon + Vaginal Misoprostol
C: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Device: ARD (Atad Ripener Device) | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Device: AID (Atad double balloon Instillation Device) | Arm Label: 3; Type: ACTIVE_COMPARATOR; Interventions: Device: folly catheter | Intervention Type: DEVICE; Name: ARD (Atad Ripener Device); Assigned to Arm(s): 1 | Intervention Type: DEVICE; Name: AID (Atad double balloon Instillation Device); Assigned to Arm(s): 2 | Intervention Type: DEVICE; Name: folly catheter; Assigned to Arm(s): 3
D: Arm Label: Cervical foley & Misoprostol; Type: EXPERIMENTAL; Interventions: Device: Cervical Foley & Misoprostol | Arm Label: Misoprostol only; Type: EXPERIMENTAL; Interventions: Drug: Misoprostol Alone | Arm Label: Cervical foley alone; Type: EXPERIMENTAL; Interventions: Device: Cervical Foley Alone | Arm Label: Cervical foley & Pitocin; Type: EXPERIMENTAL; Interventions: Device: Cervical Foley & Pitocin | Intervention Type: DEVICE; Name: Cervical Foley & Misoprostol; Assigned to Arm(s): Cervical foley & Misoprostol | Intervention Type: DRUG; Name: Misoprostol Alone; Assigned to Arm(s): Misoprostol only | Intervention Type: DEVICE; Name: Cervical Foley Alone; Assigned to Arm(s): Cervical foley alone | Intervention Type: DEVICE; Name: Cervical Foley & Pitocin; Assigned to Arm(s): Cervical foley & Pitocin

Answer: D