NCT05957666

Comparison of Oral Versus Vaginal Misoprostol for Labour Induction at Term

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Services Institute of Medical Sciences, Pakistan · Other Government
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

A randomised control trial to compare oral and vaginal misoprostol for induction of labour in term patients.The objective is to determine whether use of standardised vaginal misoprostol regimen will result in decreased cesaerean section rate among women with bishop score of lessthan or equal to 6 who require induction of labpour at term compared to oral misoprostol regimen.

Detailed description

The objective of study is to determine whether the use of standardised vaginal misoprostol regimen will result in decreased cesaerean section rate among women with bishop score of less than or equal to 6 who require induction of labour at term compared to oral misoprostol regimen.It is a randomised control trial conducted in department of obs and gynae unit 1 from june 2023. Total 176 patients are included in this study and they will be randomised by envelope method to recieve either oral or vaginal misoprostol in a dose of 50microgram.In both groupds dose will be repeated after 6 hours if required.Maximum 2 doses will be given.patients will be monitored for uterine contractions and fetal hearts.Vaginal examination will be done at 4hours and 8 hours following misoprostol dose or earlier if patient complains of leaking and labour pains.Membranes will be ruptured once cervical dilatation is greater than 3cm.in absence of adequate uterine contractions oxytocin infusion will be started.Fetal hearts will be monitored every 30 minutes from time of induction.Progress of labour will be assessed through partogram.

Conditions

• Induction of Labour With Misoprostol

Interventions

Type	Name	Description
DRUG	Misoprostol Oral Tablet	oral misoprostol 50 microgram repeated after 6 hours if required
DRUG	vaginal misoprostol	vaginal misoprostol 50 microgram repeated after 6 hours if required

Timeline

• Start date: 2023-06-16
• Primary completion: 2023-12-16
• Completion: 2023-12-16
• First posted: 2023-07-24
• Last updated: 2023-07-24

Locations

1 site across 1 country: Pakistan