Misoprostol AllergyPhase 2/3NCT03276000
Misoprostol for Cervical Priming Before Office Hysteroscopy
A Phase 2/3 study testing office hysteroscopy in people with Misoprostol Allergy, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The objective of the present study is to evaluate the appropriate route of administration of misoprostol, either oral or vaginal, for cervical priming to facilitate the procedure of office hysteroscopy and reduce patient discomfort to minimum Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Misoprostol Allergy
- What is being tested?
- office hysteroscopy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 1 Mar 2018
- Phase
- Phase 2/3
- 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 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients indicated for diagnostic hysteroscopy for infertility or AUB.
- Reproductive age >19 - 45yrs.
- Postmenstrual between days 7 and 11 of the cycle ( except in irregular bleeding)
Who cannot join
- Contraindicating the use of prostaglandins such as:-
- Cardiovascular disease
- Severe bronchial asthma.
- Hypertension.
- Renal failure.
- Known sensitivity to Prostaglandins
Show all 15Show fewer
- Contraindication to office hysteroscopy such as:-
- Pelvic inflammatory disease.
- Marked cervical stenosis.
- Known cervical malignancy.
- pregnancy
- profuse uterine bleeding
- Recent uterine perforation.
- Neurological disorders affecting the evaluation of pain.
- Previous cervical surgery.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr El Ainiy Hospital
Cairo, 11562
sarah M Hassan, Lecturer, 01003733671, saramohamed7880@yahoo.com
About this study
Official title: Randomized Control Trial Comparing Patient Acceptability and Tolerance to Pain Using Oral Versus Vaginal Misoprostol for Cervical Priming Before Office Hysteroscopy.
The objective of the present study is to evaluate the appropriate route of administration of misoprostol, either oral or vaginal, for cervical priming to facilitate the procedure of office hysteroscopy and reduce patient discomfort to minimum
Read the detailed description
Sample size calculation was done using the comparison of pain sensation represented through VAS between oral and vaginal misoprostol for cervical ripening before office hysteroscopy. As reported in previous publication (Sordia-Herna'ndez et al., 2011), the mean ±SD of VAS in oral misoprostol group was approximately 6.04 ± 1.5, while in vaginal misoprostol group was approximately 2.8 ± 1.2. Accordingly, we calculated that the minimum proper sample size was 23 women in each arm to be able to detect a real difference of 1 unit with 80% power at α = 0.05 level using Student's t test for independent samples. Sample size calculation was done using Stats Direct statistical software version 2.7.2 for MS Windows, StatsDirect Ltd., Cheshire, UK
However, the study population consists of 100 patients in reproductive age that requires diagnostic hysteroscopy for investigation of infertility or AUB.
The patients will be recruited from Office hysteroscopy clinic of the Obstetrics and Gynecology Department, Faculty of Medicine, Cairo University from October 2017 to march 2018.
The Patients will be allocated equally into 2 groups ( each group contain 50 patients)
Groups will be as follows:
- Group A: 50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before the procedure.
- Group B: 50 patients receive 200 mg misoprostol (Misotac; Sigma Pharm) 3h before the procedure moistened with saline solution will be inserted in posterior fornix of vagina.
- Conditions
- Misoprostol Allergy
- Being tested
- office hysteroscopy
- Keywords
- Misoprostol ,office hysteroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
office hysteroscopyProcedure or surgery
A rigid 30 4-mm hysteroscope (Karl Storz Endoscopy) will be used without anaesthesia or analgesia 3 hours after administration of misoprostol. The uterine cavity will be distended with normal saline solution at a pressure of 100-120 mm Hg. The vaginoscopic ''no touch'' technique was followed; no speculum or tenaculum was used.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before office hysteroscopy Receives: Procedure: office hysteroscopy |
| group B | Active comparator | 50 patients receive 200 mg misoprostol (Misotac; Sigma Pharm) 3h before office hysteroscopy moistened with saline solution will be inserted in posterior fornix of vagina. Receives: Procedure: office hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain sensation:
the level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS).
Measured: The VAS will be applied immediately after the procedure ended.
Patient acceptability
according to a 10-point VAS
Measured: The VAS will be applied immediately after the procedure ended.
Secondary outcomes (3)
Bleeding
Bleeding during and after the procedure.
Measured: during the procedure.
Procedure time
Procedure time from introduction of the office hysteroscopy through the external cervical os and the visualization of the uterine cavity.
Measured: it will be reported immediately after the process ended
Ease of cervical entry by hysteroscopy
Ease of cervical entry by hysteroscopy to evaluate the uterine cavity according to a 10-point VAS.
Measured: The VAS will be applied immediately after the procedure ended.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start1 Oct 2017
- Primary completion1 Mar 2018 (estimated)
- Study completion1 Mar 2018 (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 Misoprostol AllergyStudies 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 2/3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sarah mohamed hassan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276000
- Sponsor's protocol ID
- 12345
- Status last verified
- Oct 2017
- First submitted
- 6 Sep 2017
- Last updated
- 17 Oct 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sordia-Hernandez LH, Rosales-Tristan E, Vazquez-Mendez J, Merino M, Iglesias JL, Garza-Leal JG, Morales A. Effectiveness of misoprostol for office hysteroscopy without anesthesia in infertile patients. Fertil Steril. 2011 Feb;95(2):759-61. doi: 10.1016/j.fertnstert.2010.07.1066. Epub 2010 Aug 21.
PubMed 20728083Bastu E, Celik C, Nehir A, Dogan M, Yuksel B, Ergun B. Cervical priming before diagnostic operative hysteroscopy in infertile women: a randomized, double-blind, controlled comparison of 2 vaginal misoprostol doses. Int Surg. 2013 Apr-Jun;98(2):140-4. doi: 10.9738/INTSURG-D-12-00024.1.
PubMed 23701149El-Mazny A, Abou-Salem N. A double-blind randomized controlled trial of vaginal misoprostol for cervical priming before outpatient hysteroscopy. Fertil Steril. 2011 Oct;96(4):962-5. doi: 10.1016/j.fertnstert.2011.04.049. Epub 2011 May 14.
PubMed 21575939
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial Comparing Patient Acceptability and Tolerance to Pain Using Oral Versus Vaginal Misoprostol for Cervical Priming Before Office Hysteroscopy.
- ClinicalTrials.gov ID
- NCT03276000
- Acronym / sponsor ID
- 12345
- Conditions
- Misoprostol Allergy
- Keywords
- Misoprostol ,office hysteroscopy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Mar 2018 (estimated)
- Study completion
- 1 Mar 2018 (estimated)
- First posted
- 8 Sep 2017 (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 objective of the present study is to evaluate the appropriate route of administration of misoprostol, either oral or vaginal, for cervical priming to facilitate the procedure of office hysteroscopy and reduce patient discomfort to minimum
Detailed description
Sample size calculation was done using the comparison of pain sensation represented through VAS between oral and vaginal misoprostol for cervical ripening before office hysteroscopy. As reported in previous publication (Sordia-Herna'ndez et al., 2011), the mean ±SD of VAS in oral misoprostol group was approximately 6.04 ± 1.5, while in vaginal misoprostol group was approximately 2.8 ± 1.2. Accordingly, we calculated that the minimum proper sample size was 23 women in each arm to be able to detect a real difference of 1 unit with 80% power at α = 0.05 level using Student's t test for independent samples. Sample size calculation was done using Stats Direct statistical software version 2.7.2 for MS Windows, StatsDirect Ltd., Cheshire, UK
However, the study population consists of 100 patients in reproductive age that requires diagnostic hysteroscopy for investigation of infertility or AUB.
The patients will be recruited from Office hysteroscopy clinic of the Obstetrics and Gynecology Department, Faculty of Medicine, Cairo University from October 2017 to march 2018.
The Patients will be allocated equally into 2 groups ( each group contain 50 patients)
Groups will be as follows:
- Group A: 50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before the procedure.
- Group B: 50 patients receive 200 mg misoprostol (Misotac; Sigma Pharm) 3h before the procedure moistened with saline solution will be inserted in posterior fornix of vagina.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Procedure: office hysteroscopy50 patients receive 200 mg oral misoprostol (Misotac; Sigma Pharm) 3h before office hysteroscopy |
| group B | Active comparator | Procedure: office hysteroscopy50 patients receive 200 mg misoprostol (Misotac; Sigma Pharm) 3h before office hysteroscopy moistened with saline solution will be inserted in posterior fornix of vagina. |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients indicated for diagnostic hysteroscopy for infertility or AUB.
- Reproductive age >19 - 45yrs.
- Postmenstrual between days 7 and 11 of the cycle ( except in irregular bleeding)
Key exclusion criteria (15 listed)
- Contraindicating the use of prostaglandins such as:-
- Cardiovascular disease
- Severe bronchial asthma.
- Hypertension.
- Renal failure.
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 |
|---|---|---|
| office hysteroscopyA rigid 30 4-mm hysteroscope (Karl Storz Endoscopy) will be used without anaesthesia or analgesia 3 hours after administration of misoprostol. The uterine cavity will be distended with normal saline solution at a pressure of 100-120 mm Hg. The vaginoscopic ''no touch'' technique was followed; no speculum or tenaculum was used. | Procedure or surgery | Group A, group B |
Primary outcome
Pain sensation:
Time frame: The VAS will be applied immediately after the procedure ended.
the level of pelvic pain will be rated according to a 10-point visual analogue scale (VAS).
Patient acceptability
Time frame: The VAS will be applied immediately after the procedure ended.
according to a 10-point VAS
3 secondary outcomes
Bleeding
Time frame: during the procedure.
Procedure time
Time frame: it will be reported immediately after the process ended
Ease of cervical entry by hysteroscopy
Time frame: The VAS will be applied immediately after the procedure ended.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Background: PubMed 20728083Sordia-Hernandez LH, Rosales-Tristan E, Vazquez-Mendez J, Merino M, Iglesias JL, Garza-Leal JG, Morales A. Effectiveness of misoprostol for office hysteroscopy without anesthesia in infertile patients. Fertil Steril. 2011 Feb;95(2):759-61. doi: 10.1016/j.fertnstert.2010.07.1066. Epub 2010 Aug 21.
- Background: PubMed 23701149Bastu E, Celik C, Nehir A, Dogan M, Yuksel B, Ergun B. Cervical priming before diagnostic operative hysteroscopy in infertile women: a randomized, double-blind, controlled comparison of 2 vaginal misoprostol doses. Int Surg. 2013 Apr-Jun;98(2):140-4. doi: 10.9738/INTSURG-D-12-00024.1.
- Background: PubMed 21575939El-Mazny A, Abou-Salem N. A double-blind randomized controlled trial of vaginal misoprostol for cervical priming before outpatient hysteroscopy. Fertil Steril. 2011 Oct;96(4):962-5. doi: 10.1016/j.fertnstert.2011.04.049. Epub 2011 May 14.
- Individual participant dataSharing planned: No
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 2/3 study testing office hysteroscopy in people with Misoprostol Allergy, run by Kasr El Aini Hospital at 1 site in Egypt.
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 15 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 17 Oct 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 Egypt. 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 combined 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah M Hassan, lecturer (01003733671, saramohamed7880@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain sensation: (time frame: The VAS will be applied immediately after the procedure ended.). 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 NCT03276000, 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 17 Oct 2017.