Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Two Community Strategies Comparing Use of Misoprostol for Secondary Prevention to Primary Prevention for Postpartum Hemorrhage: A Randomized Cluster Non-Inferiority Study in Bijapur District, Karnataka, India
Brief Summary: This study compares two community-level strategies: selective administration of 800 mcg sublingual misoprostol to women at 350 mL blood loss for secondary prevention of postpartum hemorrhage (PPH) with universal use of 600 mcg oral misoprostol at the time of delivery for primary prevention of PPH. The study hypothesizes that at community-level births, secondary prevention for women is non-inferior (based on clinical parameters) to universal prophylaxis provided to women for primary prevention of PPH. This cluster-design non-inferiority trial has the potential to inform service delivery programs on clinical outcomes, program feasibility, cost and acceptability of two different community models of PPH care using misoprostol.


Options:
A: Arm Label: Carbetocin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Carbetocin | Arm Label: Oxytocin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Oxytocin | Intervention Type: DRUG; Name: Carbetocin; Assigned to Arm(s): Carbetocin | Intervention Type: DRUG; Name: Oxytocin; Assigned to Arm(s): Oxytocin
B: Arm Label: Misoprostol; Type: ACTIVE_COMPARATOR; Interventions: Other: Misoprostol + referral | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo + referral | Intervention Type: OTHER; Name: Misoprostol + referral; Assigned to Arm(s): Misoprostol | Intervention Type: OTHER; Name: Placebo + referral; Assigned to Arm(s): Placebo
C: Arm Label: Full - Train/oxy&miso/ B&M/Mentor/Phone; Type: EXPERIMENTAL; Interventions: Other: Helping Mothers Survive - Bleeding After Birth training, Other: Helping Babies Breathe, Behavioral: Mentor, Behavioral: Phone, Drug: oxytocin and misoprostol, Device: Newborn bag and mask | Arm Label: Partial - Train/oxy & miso/ B&M/Mentor; Type: EXPERIMENTAL; Interventions: Other: Helping Mothers Survive - Bleeding After Birth training, Other: Helping Babies Breathe, Behavioral: Mentor, Drug: oxytocin and misoprostol, Device: Newborn bag and mask | Arm Label: Comparison - Train/oxy & miso/ B&M; Type: ACTIVE_COMPARATOR; Interventions: Other: Helping Mothers Survive - Bleeding After Birth training, Other: Helping Babies Breathe, Drug: oxytocin and misoprostol, Device: Newborn bag and mask | Intervention Type: OTHER; Name: Helping Mothers Survive - Bleeding After Birth training; Assigned to Arm(s): Comparison - Train/oxy & miso/ B&M, Full - Train/oxy&miso/ B&M/Mentor/Phone, Partial - Train/oxy & miso/ B&M/Mentor | Intervention Type: OTHER; Name: Helping Babies Breathe; Assigned to Arm(s): Comparison - Train/oxy & miso/ B&M, Full - Train/oxy&miso/ B&M/Mentor/Phone, Partial - Train/oxy & miso/ B&M/Mentor | Intervention Type: BEHAVIORAL; Name: Mentor; Assigned to Arm(s): Full - Train/oxy&miso/ B&M/Mentor/Phone, Partial - Train/oxy & miso/ B&M/Mentor | Intervention Type: BEHAVIORAL; Name: Phone; Assigned to Arm(s): Full - Train/oxy&miso/ B&M/Mentor/Phone | Intervention Type: DRUG; Name: oxytocin and misoprostol; Assigned to Arm(s): Comparison - Train/oxy & miso/ B&M, Full - Train/oxy&miso/ B&M/Mentor/Phone, Partial - Train/oxy & miso/ B&M/Mentor | Intervention Type: DEVICE; Name: Newborn bag and mask; Assigned to Arm(s): Comparison - Train/oxy & miso/ B&M, Full - Train/oxy&miso/ B&M/Mentor/Phone, Partial - Train/oxy & miso/ B&M/Mentor
D: Arm Label: Primary prevention; Type: OTHER; Interventions: Drug: Misoprostol | Arm Label: Secondary Prevention; Type: OTHER; Interventions: Drug: Misoprostol | Intervention Type: DRUG; Name: Misoprostol; Assigned to Arm(s): Secondary Prevention | Intervention Type: DRUG; Name: Misoprostol; Assigned to Arm(s): Primary prevention

Answer: D