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OpenTrials
Completed

NCT Number: 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.

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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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Federal Teaching Hospital, Abakaliki

Abakaliki, Ebonyi State, 480001, Nigeria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Foley's Catheter

Device

intracervical extraamniotic Foley's catheter

prostaglandin E1 analogue

Drug

intravaginal misoprostol

Other names: Misoprostol

Primary outcomes

  1. Bishop Score of 6 or more

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Nwali Matthew Igwe

Other Gov

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 12, 2015
Registry last updated
Oct 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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