NCT02574338

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

2.9 years

First QC Date

October 9, 2015

Last Update Submit

October 12, 2019

Conditions

Cervical Ripening and Induction of Labor

Outcome Measures

Primary Outcomes (1)

  • Bishop Score of 6 or more

    24 hours

Study Arms (2)

group - 1 Foley's Catheter

ACTIVE COMPARATOR

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

Device: Foley's Catheter

Group - 2 Prostaglandin E1 Analogue

ACTIVE COMPARATOR

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

Drug: prostaglandin E1 analogue

Interventions

Foley's CatheterDEVICE

intracervical extraamniotic Foley's catheter

group - 1 Foley's Catheter
prostaglandin E1 analogueDRUG

intravaginal misoprostol

Also known as: Misoprostol
Group - 2 Prostaglandin E1 Analogue

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal Teaching Hospital, Abakaliki

Abakaliki, Ebonyi State, 480001, Nigeria

Location

Related Publications (1)

  • de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

    PMID: 36996264DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 9, 2015

First Posted

October 12, 2015

Study Start

September 1, 2015

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

October 15, 2019

Record last verified: 2019-10

Locations

NG(1)