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.

Cervical Ripening and Induction of Labor Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574338
• Other study ID #: MSFC-2015-CT
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: August 2018

Study information

• Verified date: October 2019
• Source: Federal Teaching Hospital Abakaliki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Ripening and Induction of Labor

Intervention

Device:
• Foley's Catheter
intracervical extraamniotic Foley's catheter

Drug:
• prostaglandin E1 analogue
intravaginal misoprostol

Locations

Country	Name	City	State
Nigeria	Federal Teaching Hospital, Abakaliki	Abakaliki	Ebonyi

Sponsors (1)

Lead Sponsor	Collaborator
Nwali Matthew Igwe

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bishop Score of 6 or more		24 hours