NCT02574338

Cervical Ripening: A Comparison Between Intravaginal Misoprostol Tablet and Intracervical Foley's Catheter and Subsequent Induction of Labor, Safety and Efficacy in Federal Teaching Hospital Abakaliki, Ebonyi State, Nigeria.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Nwali Matthew Igwe · Other Government
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

The aim of this study is to compare the effectiveness and safety of Foley's catheter and misoprostol in cervical ripening.

Detailed description

This is a randomized clinical study which will be made up of two arms or groups. The first arm or group - 1 will have cervical ripening with intracervical extraamniotic Foley's catheter while group - 2 will have cervical ripening with intravaginal misoprostol. The parturients will be randomly selected by simple lottery and recruited into the two arms of the study. Each parturient will pick by simple lucky dip from a pool of folded papers with inscription group 1 or group 2 in a bag in a double blinded manner and will be recruited into the group picked among the two arms of the study. The Bishop's score of the cervix will be accurately determined and documented before cervical ripening. Bishop's score of ≥6 will be considered ripe. Oxytocin will be used for induction or augmentation of labor as required.

Conditions

• Cervical Ripening and Induction of Labor

Interventions

Type	Name	Description
DEVICE	Foley's Catheter	intracervical extraamniotic Foley's catheter
DRUG	prostaglandin E1 analogue	intravaginal misoprostol

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2015-10-12
• Last updated: 2019-10-15

Locations

1 site across 1 country: Nigeria