About this trial
This randomized controlled trial will compare two methods of induction of labour in women with term pregnancy: concurrent use of a Foley catheter and PGE2 vaginal pessary versus sequential use of the two methods. The study will assess whether using both methods concurrently is more effective and safe than using them sequentially. The primary focus is the rate of vaginal delivery within 24 hours after initiation of induction. Participants will be women with term pregnancy (37-42 weeks) admitted for induction of labour without significant comorbidities.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant women aged 18-40 years with a singleton cephalic fetus between 37 and 42 weeks of gestation who require induction of labour, with BMI 20-35 kg/m², intact membranes, and reassuring cardiotocography (CTG), will be included.
Disqualifiers
Women with meconium-stained liquor, antepartum haemorrhage, low-lying placenta defined as placental edge less than 2 cm from the internal os on ultrasonography, pre-eclampsia, fetal growth restriction, previously scarred uterus, estimated fetal weight greater than 4 kg on ultrasound, cephalopelvic disproportion, or liquor abnormalities will be excluded.
Trial design
Parallel
Treatments tested in this trial
Foley Catheter
DeviceA Foley catheter will be used for mechanical cervical ripening. The balloon will be inflated with 30 mL of normal saline.
PGE2 Vaginal Pessary
DrugA PGE2 vaginal pessary will be used as a pharmacological method of cervical ripening during induction of labour.
Treatment groups
Trial outcomes
Primary outcomes
Time from initiation of induction of labour to vaginal delivery
Time interval from the initiation of cervical ripening intervention to vaginal delivery, measured in hours.
Successful vaginal delivery
Proportion of participants who achieve vaginal delivery following induction of labour.
Sponsors and contacts
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