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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01596296
Recruitment Status : Recruiting
First Posted : May 10, 2012
Last Update Posted : October 31, 2017
Information provided by (Responsible Party):
Seoul National University Hospital

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.

Condition or disease Intervention/treatment Phase
Failed Induction of Labor Device: Transcervical foley catheter Drug: Dinoprostone 10mg Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2012
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Transcervical foley catheter Device: Transcervical foley catheter
16 French foley catheter insertion

Active Comparator: Dinoprostone Drug: Dinoprostone 10mg
Dinoprostone vaginal insertion

Primary Outcome Measures :
  1. Successful labor induction [ Time Frame: Twelve hours of initiating oxytocin on the first 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 dinoprostone vaginal insertion [ Time Frame: When transcervical foley catheter or dinoprostone was removed before adminitoring oxytocin ]
    1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts 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

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 identifier (NCT number): NCT01596296

Contact: Kyo Hoon Park, MD, PhD 82-31-787-7252

Korea, Republic of
Department of Obstetrics and Gynecology Seoul National University Bundang Hospital Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Contact: Kyo Hoon Park, MD, PhD    82-31-787-7252   
Sponsors and Collaborators
Seoul National University Hospital
Principal Investigator: Kyo Hoon Park, MD, PhD Seoul National University Bundang Hospital

Responsible Party: Seoul National University Hospital Identifier: NCT01596296     History of Changes
Other Study ID Numbers: FCB_PG_parous women
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2016

Keywords provided by Seoul National University Hospital:
labor induction
transcervical foley catheter
parous women

Additional relevant MeSH terms:
Reproductive Control Agents
Physiological Effects of Drugs