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.

Nwali Matthew Igwe

Status: Completed

Conditions: Cervical Ripening and Induction of Labor

Treatments: Drug: prostaglandin E1 analogue; Device: Foley's Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02574338

MSFC-2015-CT

Details and patient eligibility

About

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

Full 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.

Enrollment: 135 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 2 patient groups

group - 1 Foley's Catheter

Active Comparator group

Description:

will have cervical ripening with intracervical extraamniotic Foley's catheter for 24 hours

Treatment:

Device: Foley's Catheter

Group - 2 Prostaglandin E1 Analogue

Active Comparator group

Description:

will have cervical ripening with intravaginal misoprostol inserted into the posterior fornix every six hours to a maximum of four doses (24 hours)

Treatment:

Drug: prostaglandin E1 analogue