Stenosis of CervixNCT02534883
Cervical Ripening in Postmenopausal Women
A study testing Misoprostol in people with Stenosis of Cervix, run by St. Louis University at 1 site in United States.
Trial summary
Misoprostol (Cytotec) 200ug vaginally will be given to patients 12 hours and 2 hours pre-operatively (before surgery) for a total of 400ug to ripen, soften or relax the cervix for dilation (opening). Read more about this study
- Who is it for?
- Ages 45 to 85 years, women only
- Conditions the study is for
- Stenosis of Cervix
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 45-80yrs of age
- Postmenopausal (amenorrhea for greater than 1 year)
- May or may not be using hormone replacement therapy
- Scheduled or to be scheduled for hysteroscopy/resectoscopy procedures
Who cannot join
- Pregnant
- Known Cancer
- Known hypersensitivity to prostaglandins.
- Those who are breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cervical Ripening in Postmenopausal Women: A Randomized, Double Blind, Placebo Controlled Trial
Misoprostol (Cytotec) 200ug vaginally will be given to patients 12 hours and 2 hours pre-operatively (before surgery) for a total of 400ug to ripen, soften or relax the cervix for dilation (opening). This is to assist with the insertion of a hysteroscope (the surgical instrument) into the uterus for all operative hysteroscopic procedures requiring dilation above 5 mm.
Time required for cervical dilatation will be recorded. Start time will be when the smallest dilator is placed into the endocervical canal, and stop time recorded when the desired cervical dilation is achieved with the largest dilator. Depending on the procedure, desired dilation may range between 5-10mm. Time will serve as a surrogate for operative ease of dilatation.
The investigators will compare the two groups in terms of medication, resistance, dilation time and size, side effects and surgical complications.
Read the detailed description
This study will be a randomized, double blinded, placebo controlled trial.
Patients will be assigned by chance to receive 200ug of misoprostol or placebo (empty gelatin capsule) vaginally twice (for a total of 400ug). There is no standard of care, but to receive misoprostol or not are both accepted practices and that Standard of Care is for the clinicians to use clinical judgment .
Patients will be randomized to one of the following treatment regimens:
Group 1 will received 200ug of misoprostol, to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery (a total of 400ug of misoprostol). St. Mary's pharmacy will prepare capsules with each containing 200ug of misoprostol.
Group 2 will received placebo (empty gelatin capsule), to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery.
The two groups, will be compared in terms of side effects, resistance, dilation time, size and surgical complication.
Randomization will occur using a computer program called Research Randomizer, http://www.randomizer.org/form.htm. A set of 100 non-unique numbers will be randomized. Once the randomization list is generated, envelopes will be made. Based on the randomizer results a folder slip of paper with the treatment (misoprostol or placebo) written on it will be placed in sequential numbered envelopes. The number on the envelope will be the patients code number. An unblinded member of the research team will open the randomized envelope, and log into a master drug log the randomization.
The medication and/or placebo will be place in numbered sequentially bottles with a master drug log containing which is misoprostol and which is placebo. Each bottle will have child proof lids for dispensing and will be labeled misoprostol 200ug/each/placebo), physician name (Ward) and contact number, and "For investigational use only" will also be noted.
The unblinded staff will notify the research member consenting the patient and inform them of what number bottle to give to the patient, in the office before surgery
- Conditions
- Stenosis of Cervix
- Being tested
- Misoprostol, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Cytotec
To be place vaginally
PlaceboDrug
Also called non active drug
To be placed vaginally
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Group 1 will received 200ug of misoprostol, to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery (a total of 400ug of misoprostol). Receives: Drug: Misoprostol |
| Group 2 | Placebo comparator | Group 2 will received placebo (empty gelatin capsule), to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (Cervical Ripening)
To evaluate the efficacy of two doses of 200ug of misoprostol (for a total of 400ug), administered vaginally, on cervical ripening before diagnostic and operative hysteroscopic procedures in postmenopausal women (amenorrhea greater than 1 year). Efficacy is represented by time to dilation.
Measured: At time of surgery/cervical dilation
Secondary outcomes (5)
Number of Recorded Side Effects.
Secondary aim: to evaluate if cervical ripening with misoprostol reduces side effects
Measured: At time of surgery/cervical dilation
Dilation Time in Minutes
Time from beginning of cervical dilation to completion of cervical dilation.
Measured: At time of procedure.
Maximum Dilator Size
The largest cervical dilator that could be passed through the internal cervical os.
Measured: At time of procedure.
Number of Complications
Count of complications at time of surgery.
Measured: At time of procedure.
Resistance Score
Ease of Dilation Per Surgeon on a numeric scale of 1(easier than normal) to 5 (more difficult than normal) with 3 being "normal."
Measured: At time of procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: not able to meet enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stenosis of CervixStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donald Gregory Ward, M.D., St. Louis University
- Investigators
- Donald Ward, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02534883
- Sponsor's protocol ID
- 25065
- Status last verified
- Jun 2018
- First submitted
- 25 Aug 2015
- Last updated
- 12 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Ripening in Postmenopausal Women: A Randomized, Double Blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02534883
- Acronym / sponsor ID
- 25065
- Conditions
- Stenosis of Cervix
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not able to meet enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 28 Aug 2015 (estimated)
- Results
- Posted 12 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Misoprostol (Cytotec) 200ug vaginally will be given to patients 12 hours and 2 hours pre-operatively (before surgery) for a total of 400ug to ripen, soften or relax the cervix for dilation (opening). This is to assist with the insertion of a hysteroscope (the surgical instrument) into the uterus for all operative hysteroscopic procedures requiring dilation above 5 mm.
Time required for cervical dilatation will be recorded. Start time will be when the smallest dilator is placed into the endocervical canal, and stop time recorded when the desired cervical dilation is achieved with the largest dilator. Depending on the procedure, desired dilation may range between 5-10mm. Time will serve as a surrogate for operative ease of dilatation.
The investigators will compare the two groups in terms of medication, resistance, dilation time and size, side effects and surgical complications.
Detailed description
This study will be a randomized, double blinded, placebo controlled trial.
Patients will be assigned by chance to receive 200ug of misoprostol or placebo (empty gelatin capsule) vaginally twice (for a total of 400ug). There is no standard of care, but to receive misoprostol or not are both accepted practices and that Standard of Care is for the clinicians to use clinical judgment .
Patients will be randomized to one of the following treatment regimens:
Group 1 will received 200ug of misoprostol, to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery (a total of 400ug of misoprostol). St. Mary's pharmacy will prepare capsules with each containing 200ug of misoprostol.
Group 2 will received placebo (empty gelatin capsule), to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery.
The two groups, will be compared in terms of side effects, resistance, dilation time, size and surgical complication.
Randomization will occur using a computer program called Research Randomizer, http://www.randomizer.org/form.htm. A set of 100 non-unique numbers will be randomized. Once the randomization list is generated, envelopes will be made. Based on the randomizer results a folder slip of paper with the treatment (misoprostol or placebo) written on it will be placed in sequential numbered envelopes. The number on the envelope will be the patients code number. An unblinded member of the research team will open the randomized envelope, and log into a master drug log the randomization.
The medication and/or placebo will be place in numbered sequentially bottles with a master drug log containing which is misoprostol and which is placebo. Each bottle will have child proof lids for dispensing and will be labeled misoprostol 200ug/each/placebo), physician name (Ward) and contact number, and "For investigational use only" will also be noted.
The unblinded staff will notify the research member consenting the patient and inform them of what number bottle to give to the patient, in the office before surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: MisoprostolGroup 1 will received 200ug of misoprostol, to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery (a total of 400ug of misoprostol). |
| Group 2 | Placebo comparator | Drug: PlaceboGroup 2 will received placebo (empty gelatin capsule), to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 45-80yrs of age
- Postmenopausal (amenorrhea for greater than 1 year)
- May or may not be using hormone replacement therapy
- Scheduled or to be scheduled for hysteroscopy/resectoscopy procedures
Key exclusion criteria (4 listed)
- Pregnant
- Known Cancer
- Known hypersensitivity to prostaglandins.
- Those who are breastfeeding
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 |
|---|---|---|
| MisoprostolAlso: CytotecTo be place vaginally | Drug | Group 1 |
| PlaceboAlso: non active drugTo be placed vaginally | Drug | Group 2 |
Primary outcome
Efficacy (Cervical Ripening)
Time frame: At time of surgery/cervical dilation
To evaluate the efficacy of two doses of 200ug of misoprostol (for a total of 400ug), administered vaginally, on cervical ripening before diagnostic and operative hysteroscopic procedures in postmenopausal women (amenorrhea greater than 1 year). Efficacy is represented by time to dilation.
5 secondary outcomes
Number of Recorded Side Effects.
Time frame: At time of surgery/cervical dilation
Dilation Time in Minutes
Time frame: At time of procedure.
Maximum Dilator Size
Time frame: At time of procedure.
Number of Complications
Time frame: At time of procedure.
Resistance Score
Time frame: At time of procedure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Donald Ward, MD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol in people with Stenosis of Cervix, run by St. Louis University at 1 site in United States.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 12 Jul 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Efficacy (Cervical Ripening) (time frame: At time of surgery/cervical dilation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2018.