Cervix; OpenPhase 3NCT04152317
Dose Comparison of Misoprostol for Cervix Ripening Before Operative Hysteroscopy.
A Phase 3 study testing Misoprostol 200mcg Tab and Misoprostol 800mcg Tab in people with Cervix; Open, run by Professor Fernando Figueira Integral Medicine Institute at 1 site in Brazil.
Trial summary
The medication misoprostol is used to facilitate the entry into the uterus of hysteroscopy surgery equipment and this research aims to compare the results of the use of this drug in two different doses trying to find the optimal one. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervix; Open
- What is being tested?
- Misoprostol 200mcg Tab and Misoprostol 800mcg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Nov 2019to 12 Sep 2020
- Phase
- Phase 3
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with indication for operative hysteroscopic.
Who cannot join
- Patient with contraindications to the use of prostaglandins such as asthma, glaucoma, renal failure, severe heart disease or drug allergy;
- Situations that impede the vaginal administration of medication such as major genital prolapse and virginity;
- Situations that prevent hysteroscopy as major uterine bleeding, diagnosis or suspected topical pregnancy and genital infection such as vaginosis and cervicitis;
- Situations that may influence cervical canal width such as a history of isthmo-cervical incompetence or major cervical surgery like conization or trachelotomy; presence of any structure like uterine fibroid or endometrial polyp inside the cervical canal or though the cervical os; patients on systemic or vaginal estrogen replacement therapy or who have recently used gonadotropin hormone-releasing hormone analogues.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between 200 μg and 800 μg of Misoprostol for Cervical Ripening Prior to Operative Hysteroscopy: Randomized and Quadruple Blind Clinical Trial.
The medication misoprostol is used to facilitate the entry into the uterus of hysteroscopy surgery equipment and this research aims to compare the results of the use of this drug in two different doses trying to find the optimal one.
To perform this work we will use the misoprostol and will perform a questionnaire that will be asked during hospitalization, before, during and the 12hours after the surgery.
The patients who meet the inclusion criteria after signing the Informed Consent Form will be allocated into two groups getting misoprostol 200mcg or misoprostol 800mcg.
Read the detailed description
Background: Hysteroscopy represents a minimally invasive procedure that has been increasing its adoption in the treatment of many cervical canal and uterine cavity disorders. However, difficulties related to the introduction of the equipment through the cervix are frequent. Although several studies suggest advantages in the cervical preparation with misoprostol, reducing the resistance of the uterine cervix, systematic reviews are unison to indicate the need for clarification on the ideal dose.
Aim: Compare the intra and postoperative results of patients submitted to cervical dilatation for surgical hysteroscopy with previous use of misoprostol at doses of 200mcg or 800mcg for uterine cervix preparation at Recife school hospitals.
Methods: Randomized, quadruple-blind clinical trial with patients who underwent cervical dilatation prior to surgical hysteroscopy at Recife school hospitals, Pernambuco. Patients included will be allocated randomly into two groups. The first group will use misoprostol in the dosage of 200mcg and the second, will use the dosage of 800mcg. Administration, via the vaginal route, will occur 12 hours before performing the operative hysteroscopy. The following variables will be studied: cervical canal width, cervical length, degree of difficulty, duration and failure of cervical dilation, side effects, surgical complications and patient's satisfaction. For statistical analysis, chi-square tests of association, Fisher's exact and Mann-Whitney tests will be used to compare the groups, with an alpha error of less than 5% being considered significant.
Ethical aspects: This study will comply with Resolution 466/12 of the National Health Council and was submitted to and approved by the Professor Fernando Figueira Integral Medicine Institute Research Ethics Committee, beginning only after this approval. All participants will only be included if they voluntarily agree to participate by signing the Free and Informed Consent Form.
There are no conflicts of interest.
- Conditions
- Cervix; Open
- Being tested
- Misoprostol 200mcg Tab, Misoprostol 800mcg Tab
- Keywords
- Operative Hysteroscopy, Misoprostol
- Medical subject headings
- Uterine Cervical Incompetence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol 200mcg TabDrug
Also called synthetic prostaglandin
In the misoprostol 200mcg group there will be one tablet of 200mcg and three identical tablets in shape, size and color without pharmacological properties. These four tablets will be single dose administered via vaginal route for each participant.
Misoprostol 800mcg TabDrug
Also called synthetic prostaglandin
In the misoprostol 800mcg group there will be four tablets of 200mcg. These four tablets will be single dose administered via vaginal route for each participant.
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol 200mcg | Experimental | In this group, the participants will receive 200mcg of misoprostol, single dose, via the vaginal route. Receives: Drug: Misoprostol 200mcg Tab |
| Misoprostol 800mcg | Active comparator | In this group, the participants will receive 800mcg of misoprostol, single dose, via the vaginal route. Receives: Drug: Misoprostol 800mcg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical canal width.
Maximum size of dilator that passes through the internal os without resistance.
Measured: during the surgery
Secondary outcomes (8)
Time required to dilate the cervix to 9mm.
Time necessary to achieve cervical permeability up to 9mm by introducting the Hegar dilators through the internal os.
Measured: during the surgery
Ease of cervical dilation.
The feeling of ease or difficulty reported by the surgeon while dilating the cervix.
Evaluated by LIKERT scale. It varies from one to five, one meaning very difficult and five meaning very easy .
Measured: during the surgery
Length of the cervix.
The distance between the external and the internal os measured in centimeters.
Measured: during the surgery
Abandonment of the procedure due to cervical dilation failure.
Impossibility of perform operative hysteroscopy due to difficulty to achieve complete cervical dilation up to 9mm.
Measured: during the surgery
Intraoperative complications.
Complications related to the difficulty of the dilate de cervical canal like uterine perforation, creation of false path, cervical tears and post-dilation bleeding.
Measured: during the surgery
Side effects due to the use of the misoprostol.
Adverse effects as nausea, vomiting, diarrhea, fever, chills, abdominal pain or any other complaint resulting from the use of the medication.
Measured: 24 hours
Pain intensity
The highest level of pain reported by the patient according the Visual Analog Scale evaluated at 3 moments: at the time of hospitalization, at the preoperative time (between medication administration and anesthesia onset) and at the postoperative time (12 hours after the procedure).
Measured: 24 hours
Patient satisfaction degree.
The satisfaction with the medication, reported by the participant. Evaluated by LIKERT scale. It varies from one to five, one meaning less than satisfied and five meaning very satisfied with the drug.
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 posted5 Nov 2019
- Study start7 Nov 2019
- Primary completion11 Sep 2020
- Study completion12 Sep 2020
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 Cervix; OpenStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Fernando Figueira Integral Medicine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria da Conceição Farias Souto Maior, Professor Fernando Figueira Integral Medicine Institute
- Investigators
- Aurélio Costa, PhD, Study director, Instituto Materno Infantil Prof. Fernando Figueira
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152317
- Sponsor's protocol ID
- MISO.
- Status last verified
- Oct 2020
- First submitted
- 2 Nov 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maior MDCFS, Souza ASR, Souza GFA, da Costa AAR. Comparison between 200 mug and 800 mug of vaginal misoprostol for cervical ripening before operative hysteroscopy: A randomized controlled trial. Int J Gynaecol Obstet. 2022 Jul;158(1):205-212. doi: 10.1002/ijgo.13984. Epub 2021 Nov 3.
PubMed 34695232
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between 200 μg and 800 μg of Misoprostol for Cervical Ripening Prior to Operative Hysteroscopy: Randomized and Quadruple Blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT04152317
- Acronym / sponsor ID
- MISO.
- Conditions
- Cervix; Open
- Keywords
- Operative Hysteroscopy, Misoprostol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Professor Fernando Figueira Integral Medicine InstituteUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 11 Sep 2020 (actual)
- Study completion
- 12 Sep 2020 (actual)
- First posted
- 5 Nov 2019 (actual)
- 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.
The medication misoprostol is used to facilitate the entry into the uterus of hysteroscopy surgery equipment and this research aims to compare the results of the use of this drug in two different doses trying to find the optimal one.
To perform this work we will use the misoprostol and will perform a questionnaire that will be asked during hospitalization, before, during and the 12hours after the surgery.
The patients who meet the inclusion criteria after signing the Informed Consent Form will be allocated into two groups getting misoprostol 200mcg or misoprostol 800mcg.
Detailed description
Background: Hysteroscopy represents a minimally invasive procedure that has been increasing its adoption in the treatment of many cervical canal and uterine cavity disorders. However, difficulties related to the introduction of the equipment through the cervix are frequent. Although several studies suggest advantages in the cervical preparation with misoprostol, reducing the resistance of the uterine cervix, systematic reviews are unison to indicate the need for clarification on the ideal dose.
Aim: Compare the intra and postoperative results of patients submitted to cervical dilatation for surgical hysteroscopy with previous use of misoprostol at doses of 200mcg or 800mcg for uterine cervix preparation at Recife school hospitals.
Methods: Randomized, quadruple-blind clinical trial with patients who underwent cervical dilatation prior to surgical hysteroscopy at Recife school hospitals, Pernambuco. Patients included will be allocated randomly into two groups. The first group will use misoprostol in the dosage of 200mcg and the second, will use the dosage of 800mcg. Administration, via the vaginal route, will occur 12 hours before performing the operative hysteroscopy. The following variables will be studied: cervical canal width, cervical length, degree of difficulty, duration and failure of cervical dilation, side effects, surgical complications and patient's satisfaction. For statistical analysis, chi-square tests of association, Fisher's exact and Mann-Whitney tests will be used to compare the groups, with an alpha error of less than 5% being considered significant.
Ethical aspects: This study will comply with Resolution 466/12 of the National Health Council and was submitted to and approved by the Professor Fernando Figueira Integral Medicine Institute Research Ethics Committee, beginning only after this approval. All participants will only be included if they voluntarily agree to participate by signing the Free and Informed Consent Form.
There are no conflicts of interest.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol 200mcg | Experimental | Drug: Misoprostol 200mcg TabIn this group, the participants will receive 200mcg of misoprostol, single dose, via the vaginal route. |
| Misoprostol 800mcg | Active comparator | Drug: Misoprostol 800mcg TabIn this group, the participants will receive 800mcg of misoprostol, single dose, via the vaginal route. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with indication for operative hysteroscopic.
Key exclusion criteria (4 listed)
- Patient with contraindications to the use of prostaglandins such as asthma, glaucoma, renal failure, severe heart disease or drug allergy;
- Situations that impede the vaginal administration of medication such as major genital prolapse and virginity;
- Situations that prevent hysteroscopy as major uterine bleeding, diagnosis or suspected topical pregnancy and genital infection such as vaginosis and cervicitis;
- Situations that may influence cervical canal width such as a history of isthmo-cervical incompetence or major cervical surgery like conization or trachelotomy; presence of any structure like uterine fibroid or endometrial polyp inside the cervical canal or though the cervical os; patients on systemic or vaginal estrogen replacement therapy or who have recently used gonadotropin hormone-releasing hormone analogues.
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 |
|---|---|---|
| Misoprostol 200mcg TabAlso: synthetic prostaglandinIn the misoprostol 200mcg group there will be one tablet of 200mcg and three identical tablets in shape, size and color without pharmacological properties. These four tablets will be single dose administered via vaginal route for each participant. | Drug | Misoprostol 200mcg |
| Misoprostol 800mcg TabAlso: synthetic prostaglandinIn the misoprostol 800mcg group there will be four tablets of 200mcg. These four tablets will be single dose administered via vaginal route for each participant. | Drug | Misoprostol 800mcg |
Primary outcome
Cervical canal width.
Time frame: during the surgery
Maximum size of dilator that passes through the internal os without resistance.
8 secondary outcomes
Time required to dilate the cervix to 9mm.
Time frame: during the surgery
Ease of cervical dilation.
Time frame: during the surgery
Length of the cervix.
Time frame: during the surgery
Abandonment of the procedure due to cervical dilation failure.
Time frame: during the surgery
Intraoperative complications.
Time frame: during the surgery
Side effects due to the use of the misoprostol.
Time frame: 24 hours
Pain intensity
Time frame: 24 hours
Patient satisfaction degree.
Time frame: 24 hours
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 8 Oct 2020.
- Derived from this study: PubMed 34695232Maior MDCFS, Souza ASR, Souza GFA, da Costa AAR. Comparison between 200 mug and 800 mug of vaginal misoprostol for cervical ripening before operative hysteroscopy: A randomized controlled trial. Int J Gynaecol Obstet. 2022 Jul;158(1):205-212. doi: 10.1002/ijgo.13984. Epub 2021 Nov 3.
- 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.
Aurélio Costa, PhD study director
Instituto Materno Infantil Prof. Fernando Figueira
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Misoprostol 200mcg Tab and Misoprostol 800mcg Tab in people with Cervix; Open, run by Professor Fernando Figueira Integral Medicine Institute at 1 site in Brazil.
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 1 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: finished, as of the sponsor's last update on 8 Oct 2020. 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 Brazil. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Cervical canal width. (time frame: during the surgery). 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 NCT04152317, 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 8 Oct 2020.