Labor InductionPhase 2NCT03016442
Dinoprostone Vaginal Insert Versus Double Balloon Catheter for Preinduction Cervical Ripening
A Phase 2 study testing Cook Double Balloon Catheter and Dinoprostone in people with Labor Induction, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Effıcacy of dinoprostone vaginal insert versus double- balloon catheter among women in the induction of labor Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Induction
- What is being tested?
- Cook Double Balloon Catheter and Dinoprostone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2016to Apr 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eligible women have obstetric or medical indications for labor induction with intact membranes
- singleton pregnancies,
- vertex presentations
- low Bishop scores ≤6
- gestational age ≥34 w
- reassuring fetal heart tracing on admission.
Who cannot join
- unexplained vaginal bleeding
- nonvertex presentation
- intrauterine fetal death
- prior cesarean delivery
- any scarred uterus
- any other contraindications for vaginal delivery.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi
Istanbul, 34325
Gonca Yetkin Yıldırım, MD, +90 532 3532205, goncayetkinyildirim@gmal.com
About this study
Effıcacy of dinoprostone vaginal insert versus double- balloon catheter among women in the induction of labor
Read the detailed description
The study will be conducted in the Department of Obstetrics and Gynecology at Kanuni Sultan Süleyman Education and Research Hospital ,İstanbul, Turkey, with approval of the local institutional review board. All the participants will give informed consent before beginning of the study. Women who agree to participate will be first stratified into nulliparous and multiparous groups. Randomisation will be carried out by using sealed opaque envelopes with a piece of paper inside marked 'PGE2 vaginal insert' or 'Double-balloon catheter'. Envelopes will be prepared in blocks of 20 (10 PGE2 vaginal insert and 10 double-balloon catheters) for each stratified group. Envelopes will be then shuffled and placed in boxes marked 'nulliparous' and 'multiparous'. The investigator is not blinded to the allocation procedure. The allocated envelope will be opened by the clinician performing the initial vaginal examination just prior to that examination.
In the group assigned to mechanical ripening , a double- balloon catheter (Cook Cervical Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct visualisation during a sterile speculum examination. Once both balloon enter the cervical canal, the first balloon is filled with 40 ml saline above the level of the internal os. The second (vaginal) balloon is the inflated with 20 ml of saline.Then both of them are filled with 60 ml of saline. The external end of the device is taped without traction to the medial aspect of the woman's thigh. After completion of the device placement, patients undergo continous fetal heart rate monitoring for 30 min then are allowed to ambulate.The double ballon is placed for 12 hours .
In the group randomly assigned to vaginal insert is placed high in the vaginal fornix, the patients are monitored at least 1 hour for fetal heart rate and uterine activity and they are allowed to ambulate.
After 12 hours oxytocin isadministered using a standard dose regimen to all patients.
Primary and secondary outcomes are measured.
- Conditions
- Labor Induction
- Being tested
- Cook Double Balloon Catheter, Dinoprostone
- Keywords
- Double balloon catheter, Dinoprostone, Labor induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cook Double Balloon CatheterDevice
Also called The Obstetric Cook Double Balloon Catheter
A double- balloon catheter (Cook Cervical Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct visualisation during a sterile speculum examination.İt is placed for 12 hours
DinoprostoneDrug
Also called Dinoprostone vaginal insert
10 mg of dinoprostone in a hydrogel insert is placed high in the vaginal fornix. İt is placed for 12 hours.It is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.
| Study group | Role | What they receive |
|---|---|---|
| Cook double balloon catheter | Experimental | A double- balloon catheter (Cook Cervical Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct visualisation during a sterile speculum examination İt is placed for 12 hours Receives: Device: Cook Double Balloon Catheter |
| Dinoprostone | Active comparator | 10 mg of dinoprostone in a hydrogel insert is placed high in the vaginal fornix. İt is placed for 12 hours.It is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr. Receives: Drug: Dinoprostone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal delivery after initiation of ripening within 24 hours
Measured: 24 hours
Secondary outcomes (1)
Occurence of cesarean section
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2017 (estimated)
- Study startNov 2016
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
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 Labor InductionStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonca Yetkin Yildirim, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016442
- Sponsor's protocol ID
- KanuniSSTRH -3
- Status last verified
- Nov 2016
- First submitted
- 8 Jan 2017
- Last updated
- 10 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cromi A, Ghezzi F, Uccella S, Agosti M, Serati M, Marchitelli G, Bolis P. A randomized trial of preinduction cervical ripening: dinoprostone vaginal insert versus double-balloon catheter. Am J Obstet Gynecol. 2012 Aug;207(2):125.e1-7. doi: 10.1016/j.ajog.2012.05.020. Epub 2012 Jun 1.
PubMed 22704766Connolly KA, Kohari KS, Rekawek P, Smilen BS, Miller MR, Moshier E, Factor SH, Stone JL, Bianco AT. A randomized trial of Foley balloon induction of labor trial in nulliparas (FIAT-N). Am J Obstet Gynecol. 2016 Sep;215(3):392.e1-6. doi: 10.1016/j.ajog.2016.03.034. Epub 2016 Mar 24.
PubMed 27018464de 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 10 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dinoprostone Vaginal Insert Versus Double Balloon Catheter for Preinduction Cervical Ripening
- ClinicalTrials.gov ID
- NCT03016442
- Acronym / sponsor ID
- KanuniSSTRH -3
- Conditions
- Labor Induction
- Keywords
- Double balloon catheter, Dinoprostone, Labor induction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 10 Jan 2017 (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.
Effıcacy of dinoprostone vaginal insert versus double- balloon catheter among women in the induction of labor
Detailed description
The study will be conducted in the Department of Obstetrics and Gynecology at Kanuni Sultan Süleyman Education and Research Hospital ,İstanbul, Turkey, with approval of the local institutional review board. All the participants will give informed consent before beginning of the study. Women who agree to participate will be first stratified into nulliparous and multiparous groups. Randomisation will be carried out by using sealed opaque envelopes with a piece of paper inside marked 'PGE2 vaginal insert' or 'Double-balloon catheter'. Envelopes will be prepared in blocks of 20 (10 PGE2 vaginal insert and 10 double-balloon catheters) for each stratified group. Envelopes will be then shuffled and placed in boxes marked 'nulliparous' and 'multiparous'. The investigator is not blinded to the allocation procedure. The allocated envelope will be opened by the clinician performing the initial vaginal examination just prior to that examination.
In the group assigned to mechanical ripening , a double- balloon catheter (Cook Cervical Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct visualisation during a sterile speculum examination. Once both balloon enter the cervical canal, the first balloon is filled with 40 ml saline above the level of the internal os. The second (vaginal) balloon is the inflated with 20 ml of saline.Then both of them are filled with 60 ml of saline. The external end of the device is taped without traction to the medial aspect of the woman's thigh. After completion of the device placement, patients undergo continous fetal heart rate monitoring for 30 min then are allowed to ambulate.The double ballon is placed for 12 hours .
In the group randomly assigned to vaginal insert is placed high in the vaginal fornix, the patients are monitored at least 1 hour for fetal heart rate and uterine activity and they are allowed to ambulate.
After 12 hours oxytocin isadministered using a standard dose regimen to all patients.
Primary and secondary outcomes are measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cook double balloon catheter | Experimental | Device: Cook Double Balloon CatheterA double- balloon catheter (Cook Cervical Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct visualisation during a sterile speculum examination İt is placed for 12 hours |
| Dinoprostone | Active comparator | Drug: Dinoprostone10 mg of dinoprostone in a hydrogel insert is placed high in the vaginal fornix. İt is placed for 12 hours.It is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Eligible women have obstetric or medical indications for labor induction with intact membranes
- singleton pregnancies,
- vertex presentations
- low Bishop scores ≤6
- gestational age ≥34 w
Key exclusion criteria (6 listed)
- unexplained vaginal bleeding
- nonvertex presentation
- intrauterine fetal death
- prior cesarean delivery
- any scarred uterus
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 |
|---|---|---|
| Cook Double Balloon CatheterAlso: The Obstetric Cook Double Balloon CatheterA double- balloon catheter (Cook Cervical Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct visualisation during a sterile speculum examination.İt is placed for 12 hours | Device | Cook double balloon catheter |
| DinoprostoneAlso: Dinoprostone vaginal insert10 mg of dinoprostone in a hydrogel insert is placed high in the vaginal fornix. İt is placed for 12 hours.It is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr. | Drug | Dinoprostone |
Primary outcome
Vaginal delivery after initiation of ripening within 24 hours
Time frame: 24 hours
1 secondary outcome
Occurence of cesarean section
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2017.
- Background: PubMed 22704766Cromi A, Ghezzi F, Uccella S, Agosti M, Serati M, Marchitelli G, Bolis P. A randomized trial of preinduction cervical ripening: dinoprostone vaginal insert versus double-balloon catheter. Am J Obstet Gynecol. 2012 Aug;207(2):125.e1-7. doi: 10.1016/j.ajog.2012.05.020. Epub 2012 Jun 1.
- Background: PubMed 27018464Connolly KA, Kohari KS, Rekawek P, Smilen BS, Miller MR, Moshier E, Factor SH, Stone JL, Bianco AT. A randomized trial of Foley balloon induction of labor trial in nulliparas (FIAT-N). Am J Obstet Gynecol. 2016 Sep;215(3):392.e1-6. doi: 10.1016/j.ajog.2016.03.034. Epub 2016 Mar 24.
- 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
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 Cook Double Balloon Catheter and Dinoprostone in people with Labor Induction, run by Kanuni Sultan Suleyman Training and Research 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Jan 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gonca Yetkin Yıldırım, MD (+90 5323532205, goncayetkinyildirim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal delivery after initiation of ripening within 24 hours (time frame: 24 hours). 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 NCT03016442, 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 10 Jan 2017.