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Combined Foley Catheter Balloon and PGE2 Vaginal Ovule for Induction of Labor at Term: A Randomized Study

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02861079
Recruitment Status : Completed
First Posted : August 10, 2016
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Brief Summary:
This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 in induction of labor at term. Half of participants will be used combine transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will be used alone vaginal prostaglandin E2.

Condition or disease Intervention/treatment Phase
Unfavorable Cervix, Cervical Ripening Device: Foley catheter Drug: PGE2 Phase 2

Detailed Description:
An unfavorable cervix during induction decreases the success rate of labor induction and vaginal delivery. Therefore it is required to apply cervical ripening methods for unfavorable cervices. Application of transcervical Foley catheter is an effective mechanical method and has the advantages of lower cost and lowest rate of fetal heart rate changes due to tachysystole compared with PGE1 and PGE2. Despite the advantages of mechanical methods, PGE1 and PGE2 are reported to be more effective than mechanical methods to achieve vaginal delivery within 24 hours. Although there are a lot of studies comparing PGE1, PGE2 and transcervical Foley balloon catheter separately and PGE1 combined with transcervical Foley balloon catheter, less is known about combined usage of PGE2 and transcervical Foley balloon catheter.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Compare Prostaglandin E2 Against to Combined Use of Transcervical Foley Catheter Balloon With Vaginal Prostaglandin E2 for Induction of Labor at Term: A Randomized Study
Actual Study Start Date : August 25, 2017
Actual Primary Completion Date : December 25, 2017
Actual Study Completion Date : December 25, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Propess with Foley balloon catheter
10 mg PGE2 vaginal ovul will be inserted to the posterior fornix and an 18-F Foley catheter which filling with 30 mL of saline solution will be placed into the cervix
Device: Foley catheter
An 18-F Foley catheter will insert into the endocervical canal and the balloon will fill with 30 mL of saline solution.

Drug: PGE2
10 mg PGE2 vaginal ovul (Propess,Ferring®) will place high into the posterior vaginal fornix.
Other Name: propess

Active Comparator: Propess vaginal ovule
10 mg PGE2 vaginal ovule will be inserted to the posterior fornix
Drug: PGE2
10 mg PGE2 vaginal ovul (Propess,Ferring®) will place high into the posterior vaginal fornix.
Other Name: propess




Primary Outcome Measures :
  1. induction-to- delivery time [ Time Frame: the length of time between the beginning of induction and the end of labor ]
    the length of time between the beginning of induction and the end of labor


Secondary Outcome Measures :
  1. induction-to-active phase of labor time [ Time Frame: the length of time between the beginning of induction and the onset of labor ]
    the length of time between the beginning of induction and the onset of labor



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. singleton pregnancy,
  2. gestational age ≥37 weeks,
  3. intact membranes,
  4. cephalic presentation,
  5. bishop score ≤5,
  6. had obstetrical indications for induction of labor,
  7. had less than three uterine contractions in every 10 minutes. -

Exclusion Criteria:

  1. Patients who had contraindications for vaginal delivery,
  2. previous uterine surgery,
  3. fetal malpresentation,
  4. multifetal pregnancy,
  5. more than three contractions in 10 minutes,
  6. contraindications to prostaglandins,
  7. a category II or III fetal heart rate pattern,
  8. anomalous fetus,
  9. fetal demise
  10. women with immediate delivery indications -

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): NCT02861079


Locations
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Turkey
Zeynep Kamil Education and Research Hospital
Istanbul, Turkey
Sponsors and Collaborators
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Investigators
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Study Director: ahmet eser, M.D. Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey
Publications of Results:
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Responsible Party: Ahmet Eser, medical doctor, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
ClinicalTrials.gov Identifier: NCT02861079    
Other Study ID Numbers: 117
First Posted: August 10, 2016    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No