Unfavorable Cervix, Cervical RipeningPhase 2NCT02861079
Combined Foley Catheter Balloon and PGE2 Vaginal Ovule for Induction of Labor at Term: A Randomized Study
A Phase 2 study testing Foley catheter and PGE2 in people with Unfavorable Cervix, Cervical Ripening, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Unfavorable Cervix, Cervical Ripening
- What is being tested?
- Foley catheter and PGE2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Aug 2017to 25 Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton pregnancy,
- gestational age ≥37 weeks,
- intact membranes,
- cephalic presentation,
- bishop score ≤5,
- had obstetrical indications for induction of labor,
- had less than three uterine contractions in every 10 minutes. -
Who cannot join
- Patients who had contraindications for vaginal delivery,
- previous uterine surgery,
- fetal malpresentation,
- multifetal pregnancy,
- more than three contractions in 10 minutes,
- contraindications to prostaglandins,
Show all 10Show fewer
- a category II or III fetal heart rate pattern,
- anomalous fetus,
- fetal demise
- women with immediate delivery indications -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Education and Research Hospital
Istanbul
About this study
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
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.
Read the 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.
- Conditions
- Unfavorable Cervix, Cervical Ripening
- Being tested
- Foley catheter, PGE2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foley catheterDevice
An 18-F Foley catheter will insert into the endocervical canal and the balloon will fill with 30 mL of saline solution.
PGE2Drug
Also called propess
10 mg PGE2 vaginal ovul (Propess,Ferring®) will place high into the posterior vaginal fornix.
| Study group | Role | What they receive |
|---|---|---|
| Propess with Foley balloon catheter | Experimental | 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 Receives: Device: Foley catheter; Drug: PGE2 |
| Propess vaginal ovule | Active comparator | 10 mg PGE2 vaginal ovule will be inserted to the posterior fornix Receives: Drug: PGE2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
induction-to- delivery time
the length of time between the beginning of induction and the end of labor
Measured: the length of time between the beginning of induction and the end of labor
Secondary outcomes (1)
induction-to-active phase of labor time
the length of time between the beginning of induction and the onset of labor
Measured: the length of time between the beginning of induction and the onset of labor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2016 (estimated)
- Study start25 Aug 2017
- Primary completion25 Dec 2017
- Study completion25 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Unfavorable Cervix, Cervical RipeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Eser, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Investigators
- ahmet eser, M.D., Study director, Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02861079
- Sponsor's protocol ID
- 117
- Status last verified
- Jan 2018
- First submitted
- 1 Aug 2016
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Du C, Liu Y, Liu Y, Ding H, Zhang R, Tan J. Double-balloon catheter vs. dinoprostone vaginal insert for induction of labor with an unfavorable cervix. Arch Gynecol Obstet. 2015 Jun;291(6):1221-7. doi: 10.1007/s00404-014-3547-3. Epub 2014 Nov 19.
PubMed 25408273Dalui R, Suri V, Ray P, Gupta I. Comparison of extraamniotic Foley catheter and intracervical prostaglandin E gel for preinduction cervical ripening. Acta Obstet Gynecol Scand. 2005 Apr;84(4):362-7. doi: 10.1111/j.0001-6349.2005.00662.x.
PubMed 15762966de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
PubMed 36996264
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02861079
- Acronym / sponsor ID
- 117
- Conditions
- Unfavorable Cervix, Cervical Ripening
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 25 Aug 2017 (actual)
- Primary completion
- 25 Dec 2017 (actual)
- Study completion
- 25 Dec 2017 (actual)
- First posted
- 10 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propess with Foley balloon catheter | Experimental | Device: Foley catheter, Drug: PGE210 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 |
| Propess vaginal ovule | Active comparator | Drug: PGE210 mg PGE2 vaginal ovule will be inserted to the posterior fornix |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- singleton pregnancy,
- gestational age ≥37 weeks,
- intact membranes,
- cephalic presentation,
- bishop score ≤5,
Key exclusion criteria (10 listed)
- Patients who had contraindications for vaginal delivery,
- previous uterine surgery,
- fetal malpresentation,
- multifetal pregnancy,
- more than three contractions in 10 minutes,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Foley catheterAn 18-F Foley catheter will insert into the endocervical canal and the balloon will fill with 30 mL of saline solution. | Device | Propess with Foley balloon catheter |
| PGE2Also: propess10 mg PGE2 vaginal ovul (Propess,Ferring®) will place high into the posterior vaginal fornix. | Drug | Propess vaginal ovule, Propess with Foley balloon catheter |
Primary outcome
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
1 secondary outcome
induction-to-active phase of labor time
Time frame: the length of time between the beginning of induction and the onset of labor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Results publication: PubMed 25408273Du C, Liu Y, Liu Y, Ding H, Zhang R, Tan J. Double-balloon catheter vs. dinoprostone vaginal insert for induction of labor with an unfavorable cervix. Arch Gynecol Obstet. 2015 Jun;291(6):1221-7. doi: 10.1007/s00404-014-3547-3. Epub 2014 Nov 19.
- Results publication: PubMed 15762966Dalui R, Suri V, Ray P, Gupta I. Comparison of extraamniotic Foley catheter and intracervical prostaglandin E gel for preinduction cervical ripening. Acta Obstet Gynecol Scand. 2005 Apr;84(4):362-7. doi: 10.1111/j.0001-6349.2005.00662.x.
- Derived from this study: PubMed 36996264de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
- Individual participant dataSharing planned: Undecided
Related trials for Unfavorable Cervix, Cervical Ripening
RecruitingPhase 3
Oxytocin vs Prostaglandins for Labor Induction of Women With an Unfavorable Cervix After 24h of Cervical Ripening
Cervical Ripening, Unfavorable Cervix
Recruiting
PGE2 Followed by Oxytocin vs Oxytocin in Term PROM (POXY-PROM)
Premature Rupture of Fetal Membranes, Labor, Induced
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ahmet eser, M.D. study director
Zeynep Kamil Maternity and Children's Training and Research Hospital, Department of Obstetrics and Gynecology, Istanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Foley catheter and PGE2 in people with Unfavorable Cervix, Cervical Ripening, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
induction-to- delivery time (time frame: the length of time between the beginning of induction and the end of labor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02861079, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.