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

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ClinicalTrials.gov Identifier: NCT01317862
Recruitment Status : Completed
First Posted : March 17, 2011
Last Update Posted : December 10, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Failed Induction of Labor Device: Transcervical foley catheter, Prostaglandins

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2011
Primary Completion Date : September 2012
Study Completion Date : September 2012
Arms and Interventions

Arm Intervention/treatment
Active Comparator: Transcervical foley catheter Device: Transcervical foley catheter, Prostaglandins
16 French foley catheter 10mg dinoprostone vaginal insert
Active Comparator: Prostaglandins Device: Transcervical foley catheter, Prostaglandins
16 French foley catheter 10mg dinoprostone vaginal insert


Outcome Measures

Primary Outcome Measures :
  1. Successful labor induction [ Time Frame: Twelve hours of initiating oxytocin on the fist day of induction ]
    Successful labor induction is defined as an ability to achieve the active phase of labor corresponding to a cervical dilatation of >=4cm.


Secondary Outcome Measures :
  1. Cervical change in the bishop scores and cervical lengths induced by transcervical foley catheter and prostaglandins [ Time Frame: When transcervical foley catheter or prostagladins was removed befor adminitoring oxytocin ]
    1. 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


Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317862


Locations
Korea, Republic of
Department of Obstetrics and Gynecology Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Kyo Hoon Park, MD, PhD Seoul National University Bundang Hospital
More Information

Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01317862     History of Changes
Other Study ID Numbers: FCB_PG_01
First Posted: March 17, 2011    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013

Keywords provided by Seoul National University Hospital:
labor induction, transcervical foley catheter, prostaglandin