Cervical RipeningPhase 4NCT01620814
Intravaginal Misoprostol Versus Dinoprostone Before Diagnostik Hysteroscopy
A Phase 4 study testing Dinoprostone and misoprostol in people with Cervical Ripening, run by Zekai Tahir Burak Women's Health Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Comparison of intravaginal misoprostol and dinoprostol for the purpose of cervical ripening before diagnostic hysteroscopy in the women at the reproductive age:RANDOMİSED,CONTROLLED PROSPECTİVE TRİAL Objective. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Ripening
- What is being tested?
- Dinoprostone and misoprostol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2012to Sep 2012
- Phase
- Phase 4
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- on the HSG,USG or SIS,
- women at the age of primary or secondary infertile reproductive suspected for intrauterine pathology,
- no contraindication for hysteroscopy and reproductive age
Who cannot join
- women are with allergy against to prostaglandins,
- with diseases in which prostaglandin usage is contraindicated,
- pregnant,
- don't given approval,
- with cervical surgery history and cervical insufficiency.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Zekai Tahir Burak Women Health Education Research Hospital
Ankara
Turgut Var, M.D., 05323719862, drturgtvar@yahoo.com
Esra Tonguc, M.D.
About this study
Official title: Comparison of Intravaginal Misoprostol and Dinoprostol for the Purpose of Cervical Ripening Before Diagnostic Hysteroscopy in the Women at the Reproductive Age:RANDOMİSED,CONTROLLED PROSPECTİVE TRİAL
Comparison of intravaginal misoprostol and dinoprostol for the purpose of cervical ripening before diagnostic hysteroscopy in the women at the reproductive age:RANDOMİSED,CONTROLLED PROSPECTİVE TRİAL Objective. Comparison with one another and with control group of vaginal dinoprostol and misoprostol with for the purpose of cervical ripening before diagnostic hysteroscopy.
Population: It was planned for performing to 95 women who appealed to gynecology polyclinic and will be performed diagnostic hysteroscopy.
Methods: Eighty-six women who will be performed diagnostic hysteroscopy assigned as randomize to three groups. It was planned that none procedure will be applied to group 1 for cervical ripening, vaginal misoprostol and vaginal dinoprostone will be practiced to Groups 2 and 3, respectively.
Read the detailed description
While diagnostic hysteroscopy allows panoramic view of the uterus cavity, operational hysteroscopy allows to minimal invasive approach in the intrauterine lesions. Most frequently complications of hysteroscopy are cervical rupture, hemorrhage, failure of passage formation and uterus perforation. These generally are related to cervix dilatation's difficulty. These complications can be minimized preoperatively by the cervical ripening.
Present clinic study will be performed on the patients who appealed to gynecology polyclinic of the Konya TRH by the reason of infertility and infertility polyclinic of Zekai Tahir Burak Women Health Education and Research Hospital were planned diagnostic hysteroscopy by intrauterine pathology prediagnosis.Women will be given information about study and written informed consent will be obtained Inclusion criteria: On the HSG,USG or SIS, women at the age of primary or secondary infertile reproductive suspected for intrauterine pathology, no contraindication for hysteroscopy and reproductive age Exclusion criteria: Women are with allergy against to prostaglandins, with diseases in which prostaglandin usage is contraindicated, pregnant, don't given approval, with cervical surgery history and cervical insufficiency.
Post randomization. For the purpose of cervical ripening none procedure will be performed to Group 1, while vaginal misoprostole of 200 mg and vaginal dinoprostone will be applied to Group 2 and 3, respectively. While misoprostol will be implanted 3 hours before procedure, but dinoprostone will be implanted 6 hours before procedure. Before drug implantation for determination of the cervical insufficiency and measure of the cervical canal's opening, bougies will be applied toward to back from 8 no- hegar bougie.
After drugs administration, cervical canal will be again evaluated with above mentioned way by bougie before hysteroscopy, patients whose cervixes were easily passed via 5.5 no-hegar bougie, haven't cervical dislocation requirement and then directly hysteroscopy will be applied to them. Other patients will be applied cervical dislocation up to 6 no- hegar bougie before hysteroscopy. These processes also will be applied to patients of the Group 1.
- Conditions
- Cervical Ripening
- Being tested
- Dinoprostone, misoprostol, control
- Keywords
- misoprostol, dinoprostone, cervical ripening, diagnostic hysteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DinoprostoneDrug
Also called group 3
misoprostolDrug
Also called group 2
controlDrug
Also called group 1
| Study group | Role | What they receive |
|---|---|---|
| Dinoprostone and misoprostol | Experimental | For the purpose of cervical ripening none procedure will be performed to Group 1, while vaginal misoprostole of 200 mg and vaginal dinoprostone will be applied to Group 2 and 3, respectively. While misoprostol will be implanted 3 hours before procedure, but dinoprostone will be implanted 6 hours before procedure. Before drug implantation for determination of the cervical insufficiency and measure of the cervical canal's opening, bougies will be applied toward to back from 8 no- hegar bougie.
After drugs administration, cervical canal will be again evaluated with above mentioned way by bougie before hysteroscopy Receives: Drug: Dinoprostone; Drug: misoprostol |
| Misoprostol and control | Experimental | For the purpose of cervical ripening none procedure will be performed to Group 1, while vaginal misoprostole of 200 mg and vaginal dinoprostone will be applied to Group 2 and 3, respectively. While misoprostol will be implanted 3 hours before procedure, but dinoprostone will be implanted 6 hours before procedure. Before drug implantation for determination of the cervical insufficiency and measure of the cervical canal's opening, bougies will be applied toward to back from 8 no- hegar bougie. Receives: Drug: misoprostol; Drug: control |
| dinoprostone and control | Experimental | For the purpose of cervical ripening none procedure will be performed to Group 1, while vaginal misoprostole of 200 mg and vaginal dinoprostone will be applied to Group 2 and 3, respectively. While misoprostol will be implanted 3 hours before procedure, but dinoprostone will be implanted 6 hours before procedure. Before drug implantation for determination of the cervical insufficiency and measure of the cervical canal's opening, bougies will be applied toward to back from 8 no- hegar bougie. Receives: Drug: Dinoprostone; Drug: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
need for cervical dilatation
In the all three groups, patients being necessary cervical dilatation will be determined and their rates will be calculated.
Measured: 2 Months
Duration of cervical dilatation
In the patients being necessary cervical dilatation, elapsed time for dilatation will be calculated.
Measured: 2 Months
Secondary outcomes (3)
Ease of dilatation
For determination of dilatation's ease 5-point Likert scale will be used.
Measured: 2 Months
Dilatation complications
Cervical ruptures, haemorrhagee, uterine perforation and false passage will be evaluated as complication.
Measured: 2 Months
Adverse effects
Side effects developing due to drugs in the patients who are in the drug treated- group will be evaluated.
Measured: 2 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Tonguc, Zekai Tahir Burak Women's Health Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01620814
- Sponsor's protocol ID
- 2012-31
- Status last verified
- Aug 2012
- First submitted
- 7 Jun 2012
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Inal HA, Ozturk Inal ZH, Tonguc E, Var T. Comparison of vaginal misoprostol and dinoprostone for cervical ripening before diagnostic hysteroscopy in nulliparous women. Fertil Steril. 2015 May;103(5):1326-31. doi: 10.1016/j.fertnstert.2015.01.037. Epub 2015 Feb 21.
PubMed 25712577
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravaginal Misoprostol and Dinoprostol for the Purpose of Cervical Ripening Before Diagnostic Hysteroscopy in the Women at the Reproductive Age:RANDOMİSED,CONTROLLED PROSPECTİVE TRİAL
- ClinicalTrials.gov ID
- NCT01620814
- Acronym / sponsor ID
- 2012-31
- Conditions
- Cervical Ripening
- Keywords
- misoprostol, dinoprostone, cervical ripening, diagnostic hysteroscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zekai Tahir Burak Women's Health Research and Education HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 15 Jun 2012 (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.
Comparison of intravaginal misoprostol and dinoprostol for the purpose of cervical ripening before diagnostic hysteroscopy in the women at the reproductive age:RANDOMİSED,CONTROLLED PROSPECTİVE TRİAL Objective. Comparison with one another and with control group of vaginal dinoprostol and misoprostol with for the purpose of cervical ripening before diagnostic hysteroscopy.
Population: It was planned for performing to 95 women who appealed to gynecology polyclinic and will be performed diagnostic hysteroscopy.
Methods: Eighty-six women who will be performed diagnostic hysteroscopy assigned as randomize to three groups. It was planned that none procedure will be applied to group 1 for cervical ripening, vaginal misoprostol and vaginal dinoprostone will be practiced to Groups 2 and 3, respectively.
Detailed description
While diagnostic hysteroscopy allows panoramic view of the uterus cavity, operational hysteroscopy allows to minimal invasive approach in the intrauterine lesions. Most frequently complications of hysteroscopy are cervical rupture, hemorrhage, failure of passage formation and uterus perforation. These generally are related to cervix dilatation's difficulty. These complications can be minimized preoperatively by the cervical ripening.
Present clinic study will be performed on the patients who appealed to gynecology polyclinic of the Konya TRH by the reason of infertility and infertility polyclinic of Zekai Tahir Burak Women Health Education and Research Hospital were planned diagnostic hysteroscopy by intrauterine pathology prediagnosis.Women will be given information about study and written informed consent will be obtained Inclusion criteria: On the HSG,USG or SIS, women at the age of primary or secondary infertile reproductive suspected for intrauterine pathology, no contraindication for hysteroscopy and reproductive age Exclusion criteria: Women are with allergy against to prostaglandins, with diseases in which prostaglandin usage is contraindicated, pregnant, don't given approval, with cervical surgery history and cervical insufficiency.
Post randomization. For the purpose of cervical ripening none procedure will be performed to Group 1, while vaginal misoprostole of 200 mg and vaginal dinoprostone will be applied to Group 2 and 3, respectively. While misoprostol will be implanted 3 hours before procedure, but dinoprostone will be implanted 6 hours before procedure. Before drug implantation for determination of the cervical insufficiency and measure of the cervical canal's opening, bougies will be applied toward to back from 8 no- hegar bougie.
After drugs administration, cervical canal will be again evaluated with above mentioned way by bougie before hysteroscopy, patients whose cervixes were easily passed via 5.5 no-hegar bougie, haven't cervical dislocation requirement and then directly hysteroscopy will be applied to them. Other patients will be applied cervical dislocation up to 6 no- hegar bougie before hysteroscopy. These processes also will be applied to patients of the Group 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dinoprostone and misoprostol | Experimental | Drug: Dinoprostone, Drug: misoprostolFor the purpose of cervical ripening none procedure will be performed to Group 1, while vaginal misoprostole of 200 mg and vaginal dinoprostone will be applied to Group 2 and 3, respectively. While misoprostol will be implanted 3 hours before procedure, but dinoprostone will be implanted 6 hours before procedure. Before drug implantation for determination of the cervical insufficiency and measure of the cervical canal's opening, bougies will be applied toward to back from 8 no- hegar bougie. After drugs administration, cervical canal will be again evaluated with above mentioned way by bougie before hysteroscopy |
| Misoprostol and control | Experimental | Drug: misoprostol, Drug: controlFor the purpose of cervical ripening none procedure will be performed to Group 1, while vaginal misoprostole of 200 mg and vaginal dinoprostone will be applied to Group 2 and 3, respectively. While misoprostol will be implanted 3 hours before procedure, but dinoprostone will be implanted 6 hours before procedure. Before drug implantation for determination of the cervical insufficiency and measure of the cervical canal's opening, bougies will be applied toward to back from 8 no- hegar bougie. |
| dinoprostone and control | Experimental | Drug: Dinoprostone, Drug: controlFor the purpose of cervical ripening none procedure will be performed to Group 1, while vaginal misoprostole of 200 mg and vaginal dinoprostone will be applied to Group 2 and 3, respectively. While misoprostol will be implanted 3 hours before procedure, but dinoprostone will be implanted 6 hours before procedure. Before drug implantation for determination of the cervical insufficiency and measure of the cervical canal's opening, bougies will be applied toward to back from 8 no- hegar bougie. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- on the HSG,USG or SIS,
- women at the age of primary or secondary infertile reproductive suspected for intrauterine pathology,
- no contraindication for hysteroscopy and reproductive age
Key exclusion criteria (5 listed)
- women are with allergy against to prostaglandins,
- with diseases in which prostaglandin usage is contraindicated,
- pregnant,
- don't given approval,
- with cervical surgery history and cervical insufficiency.
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 |
|---|---|---|
| DinoprostoneAlso: group 3 | Drug | Dinoprostone and misoprostol, dinoprostone and control |
| misoprostolAlso: group 2 | Drug | Dinoprostone and misoprostol, Misoprostol and control |
| controlAlso: group 1 | Drug | Misoprostol and control, dinoprostone and control |
Primary outcome
need for cervical dilatation
Time frame: 2 Months
In the all three groups, patients being necessary cervical dilatation will be determined and their rates will be calculated.
Duration of cervical dilatation
Time frame: 2 Months
In the patients being necessary cervical dilatation, elapsed time for dilatation will be calculated.
3 secondary outcomes
Ease of dilatation
Time frame: 2 Months
Dilatation complications
Time frame: 2 Months
Adverse effects
Time frame: 2 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Derived from this study: PubMed 25712577Inal HA, Ozturk Inal ZH, Tonguc E, Var T. Comparison of vaginal misoprostol and dinoprostone for cervical ripening before diagnostic hysteroscopy in nulliparous women. Fertil Steril. 2015 May;103(5):1326-31. doi: 10.1016/j.fertnstert.2015.01.037. Epub 2015 Feb 21.
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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 4 study testing Dinoprostone and misoprostol in people with Cervical Ripening, run by Zekai Tahir Burak Women's Health Research and Education 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 3 inclusion and 5 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 7 Aug 2012. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Esra Tonguc, M.D. (053241414889, esratonguc@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
need for cervical dilatation (time frame: 2 Months). The study lists 2 primary outcomes in all. 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 NCT01620814, which also lists 1 linked publication.
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 7 Aug 2012.