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.

Not Applicable

Completed

• Conditions: Cervical Ripening and Induction of Labor
• Interventions: Device: Foley's Catheter; Drug: prostaglandin E1 analogue

• Registration Number: NCT02574338
• Lead Sponsor: Nwali Matthew Igwe

Brief 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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-10-09
• Study First Submitted QC: 2015-10-09
• Study First Posted: 2015-10-12
• Primary Completion: 2018-08
• Study Completion: 2018-08
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-12
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 135

Inclusion Criteria

• Parturients who gave consent
• has low bishop score (≤5)
• term singleton cephalic presenting fetus
• intact membranes
• no contraindication to vaginal delivery

Exclusion Criteria

• those who refused consent
• preterm delivery
• vaginal infection
• non-cephalic presentation
• multiple gestation
• low lying placenta/previa,
• vaginal bleeding,
• previous cesarean section
• rupture of membranes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group - 1 Foley's Catheter	Foley's Catheter	will have cervical ripening with intracervical extraamniotic Foley's catheter for 24 hours
Group - 2 Prostaglandin E1 Analogue	prostaglandin E1 analogue	will have cervical ripening with intravaginal misoprostol inserted into the posterior fornix every six hours to a maximum of four doses (24 hours)

Primary Outcome Measures

Name	Time	Method
Bishop Score of 6 or more	24 hours

Trial Locations

Locations (1)

Federal Teaching Hospital, Abakaliki; 🇳🇬 Abakaliki, Ebonyi, Nigeria