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Foley Catheter Versus Dinoprostone Vaginal Insert for Induction of Labor in Parous Women at Term: A Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01596296
Enrollment
154
Registered
2012-05-10
Start date
2012-05-31
Completion date
2017-10-31
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failed Induction of Labor

Keywords

labor induction, transcervical foley catheter, dinoprostone, parous women

Brief summary

The purpose of this study is to assess the effectiveness and safety of transcervical foley catheter as compared to dinoprostone vaginal insertion for preinduction cervical ripening and labor induction in term parous women with unfavorable cervix.

Interventions

16 French foley catheter insertion

Dinoprostone vaginal insertion

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* singleton pregnancy * parous women * gestational age \>=37.0 weeks * Bishop score \<=5 * intact amniotic membrane * absence of labor * live fetus with vertex presentation * no previous uterine surgical procedure

Exclusion criteria

* major congenital anomaly

Design outcomes

Primary

MeasureTime frameDescription
Successful labor inductionTwelve hours of initiating oxytocin on the first day of inductionSuccessful labor induction is defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of \>=4cm.

Secondary

MeasureTime frameDescription
Cervical change in the bishop scores and cervical lengths induced by transcervical foley catheter and dinoprostone vaginal insertionWhen transcervical foley catheter or dinoprostone was removed before adminitoring oxytocin1. Cervical change based on the bishop score and cervical length induced by cervical ripening methods(foley catheter balloon vs dinoprostone) 2. Incidence of cesarean delivery 3. Vaginal delivery with 24 hours of starting of induction 4. The interval from start of oxytocin to delivery 5. Incidence of admission to neonatal intensive care unit and uterine tachysystole

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026