Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Induction of Labour in Pre-eclamptic Women: a Randomised Trial Comparing the Foley Balloon Catheter With Oral Misoprostol
Brief Summary: Between 40,000 and 80,000 pregnant women die annually from pre-eclampsia and eclampsia. Magnesium sulphate and anti-hypertensive therapies can reduce the morbidity associated with pre-eclampsia. The only cure, however, comes with delivery. Prompt delivery of the baby, preferably by vaginal route, is vital in order to achieve good maternal and neonatal outcomes. Induction of labour is therefore a critical intervention in order to prevent morbidity to both mother and baby. Two low cost interventions - oral misoprostol tablets and transcervical Foley catheterization - are already used by some in low resource settings, but their relative risks and benefits are not known. These interventions could optimize the care pathway for women needing induction of labour. This is especially important in low resource settings where improvement is most needed and the potential to reduce the maternal and neonatal mortality and morbidity is the greatest. The ideal induction agent would result in a relatively short induction to delivery interval without risk to fetus and with low rates of emergency caesarean section. The induction to delivery interval is especially important in pre-eclampsia and eclampsia where the condition may deteriorate rapidly until delivery. Inductions with prostaglandins, including misoprostol, are sometimes associated with uterine hyperstimulation and consequent fetal hypoxia, whilst the effectiveness and safety of Foley catheter as an induction agent has been persistently questioned. This study will identify the risk, benefits and trade-offs in efficacy, safety, acceptability and cost of these two low cost induction methods.


Options:
A: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: misoprostol | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: dinoprostone | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Device: Bard Catheter (balloon catheter) | Intervention Type: DRUG; Name: misoprostol; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: dinoprostone; Assigned to Arm(s): 2 | Intervention Type: DEVICE; Name: Bard Catheter (balloon catheter); Assigned to Arm(s): 3
B: Arm Label: Misoprostol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Misoprostol | Arm Label: Foley Catheter; Type: ACTIVE_COMPARATOR; Interventions: Device: Foley Catheter | Intervention Type: DEVICE; Name: Foley Catheter; Assigned to Arm(s): Foley Catheter | Intervention Type: DRUG; Name: Misoprostol; Assigned to Arm(s): Misoprostol
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: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Oxytocin; Type: EXPERIMENTAL; Interventions: Drug: Oxytocin | Arm Label: PROMS Foley and oxytocin; Type: EXPERIMENTAL; Interventions: Drug: Oxytocin | Arm Label: PROMS no Foley bulb; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Oxytocin; Assigned to Arm(s): Oxytocin, PROMS Foley and oxytocin

Answer: B