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A Comparison of Transcervical Foley Catheter and Prostaglandins for Induction of Labor at Term

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01317862
Enrollment
154
Registered
2011-03-17
Start date
2011-01-31
Completion date
2012-09-30
Last updated
2013-12-10

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, prostaglandin

Brief summary

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

Interventions

DEVICETranscervical foley catheter, Prostaglandins

16 French foley catheter 10mg dinoprostone vaginal insert

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 * nulliparous women * gestational age \>= 37.0 weeks * Bishop score \<= 5 * intact amniotic membrane * abscence 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 fist 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 prostaglandinsWhen transcervical foley catheter or prostagladins was removed befor adminitoring oxytocin1. Cervical change based on the bishop score and cervical length induced by cervical ripening method(foley catheter balloon vs prostaglandin) 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 6. Pain score by the type of ripening method

Countries

South Korea

Outcome results

None listed

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