Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Induction of Labor With a Foley Catheter Balloon: A Randomized Trial Comparing Inflation With 30ml and 60ml
Brief Summary: The rate of labor induction is rising throughout the United States for a variety of reasons. Medical conditions that lead to increased risk of prolonging the pregnancy to both mother and fetus are not infrequent. In addition, elective deliveries are becoming more common. Foley balloon catheter placement is a common method used for labor induction in women with an unfavorable cervical assessment. There are several studies using various volumes of Foley balloon catheters for labor induction ranging from 30ml to 80ml, however, there are no studies replicating the findings of the largest study comparing 2 different volumes in the balloon. The investigators plan to compare instillation of 30ml of sterile saline versus 60ml in a Foley balloon catheter for women undergoing induction of labor with an unfavorable cervix. The investigators will observe the following outcomes: rate of delivery within 24 hours, cervical dilation after foley balloon catheter expulsion, insertion to balloon expulsion interval, induction to delivery time interval, peak oxytocin requirement, presence of infection or meconium, cesarean delivery rate, operative vaginal delivery rate, indication for operative vaginal or cesarean delivery, cervical laceration rate, placental abruption rate, 5-minute Apgar score, and umbilical cord arterial blood pH and base excess.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Procedure: Induction of labor with foley balloon - 60cc of saline | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Induction of labor with foley balloon with 30cc | Intervention Type: PROCEDURE; Name: Induction of labor with foley balloon - 60cc of saline; Assigned to Arm(s): 1 | Intervention Type: PROCEDURE; Name: Induction of labor with foley balloon with 30cc; Assigned to Arm(s): 2
B: 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
C: Arm Label: folye catheter plus vaginal IMN; Type: EXPERIMENTAL; Interventions: Device: foley catheter, Drug: Vaginal IMN | Arm Label: Misoprostol vaginally; Type: ACTIVE_COMPARATOR; Interventions: Drug: Misoprostol | Intervention Type: DEVICE; Name: foley catheter; Assigned to Arm(s): folye catheter plus vaginal IMN | Intervention Type: DRUG; Name: Misoprostol; Assigned to Arm(s): Misoprostol vaginally | Intervention Type: DRUG; Name: Vaginal IMN; Assigned to Arm(s): folye catheter plus vaginal IMN
D: Arm Label: Expectant management (EM) arm; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Induction of Labor (IOL) arm; Type: EXPERIMENTAL; Interventions: Procedure: Induction of Labor | Intervention Type: PROCEDURE; Name: Induction of Labor; Assigned to Arm(s): Induction of Labor (IOL) arm

Answer: A