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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-08-31

Brief Summary

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

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Detailed Description

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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

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Cervical Ripening and Induction of Labor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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group - 1 Foley's Catheter

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

Group Type ACTIVE_COMPARATOR

Foley's Catheter

Intervention Type DEVICE

intracervical extraamniotic Foley's catheter

Group - 2 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)

Group Type ACTIVE_COMPARATOR

prostaglandin E1 analogue

Intervention Type DRUG

intravaginal misoprostol

Interventions

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Foley's Catheter

intracervical extraamniotic Foley's catheter

Intervention Type DEVICE

prostaglandin E1 analogue

intravaginal misoprostol

Intervention Type DRUG

Other Intervention Names

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Misoprostol

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes