Abnormal Uterine BleedingNCT03638856
Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Hysteroscopy
A study testing Misoprostol 200Mcg Tab in people with Abnormal Uterine Bleeding and Chronic Pelvic Pain, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
Research objective To compare effectiveness of oral Misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy Research hypothesis: Null hypothesis Effectiveness of oral misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy is not different from… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Abnormal Uterine Bleeding, Chronic Pelvic Pain, Infertility, Female
- What is being tested?
- Misoprostol 200Mcg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteThailand
- Study dates
- 30 Sep 2018to 30 Dec 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Premenopausal women
- Patients have following indication for diagnosis hysteroscopy
- Abnormal uterine bleeding
- Unexplained infertility
- Recurrent pregnancy loss
- Chronic pelvic pain
- Late postpartum hemorrhage
- Patients provided written informed consent
Who cannot join
- Postmenopausal women
- Patients who have contraindication for Misoprostal as following
- Allergic to Misoprostal
- Medical illnesses such as cardiovascular diseases, Asthma, Renal disease
- Patients who have contraindication for Hysteroscopoy as following
- Pregnant women
Show all 9Show fewer
- Pelvic inflammatory disease
- Infection at cervix and vagina
- Cervical cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Premenopausal Women Underwent to Diagnostic Hysteroscopy: Double-blind, Randomized Placebo-Controlled Trial
Research objective To compare effectiveness of oral Misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy Research hypothesis: Null hypothesis Effectiveness of oral misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy is not different from placebo Alternative hypothesis: : Oral Misoprostal for cervical priming in Premenopausal women underwent to diagnostic hysteroscopy is better than placebo
Read the detailed description
Research design Randomized double-blinded placebo-controlled trial. The investigators who assess the outcomes and the participants do not know Misoprostal group or control group. The patients are given the random concealed envelop which contains Misoprostal or placebo to take before hysteroscopy. Surgeon and the investigator whom assess patients do not know group allocation.
- Being tested
- Misoprostol 200Mcg Tab
- Keywords
- Cervical priming, Diagnosis hysteroscopy, Oral Misoprostal, Premenopause
- Medical subject headings
- Metrorrhagia, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol 200Mcg TabDrug
patient takes 2 tab of 200 mcg of Misoprostal 3 hr before hysteroscopy
| Study group | Role | What they receive |
|---|---|---|
| Misoprostal group | Experimental | Patients were added oral Misoprostal 200 mcg 2 tab per oral 3 hour before hysteroscopy Receives: Drug: Misoprostol 200Mcg Tab |
| Placebo group | No intervention | Patients were take placebo 2 tab per oral 3 hour before hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
initial cervical diameter
The initial hedgar dilator number which can easily insert through cervix
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start30 Sep 2018
- Primary completion30 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abnormal Uterine BleedingStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638856
- Sponsor's protocol ID
- Rjcyto2531
- Status last verified
- Jun 2018
- First submitted
- 1 Jun 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Premenopausal Women Underwent to Diagnostic Hysteroscopy: Double-blind, Randomized Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT03638856
- Acronym / sponsor ID
- Rjcyto2531
- Keywords
- Cervical priming, Diagnosis hysteroscopy, Oral Misoprostal, Premenopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 30 Sep 2018 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 20 Aug 2018 (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.
Research objective To compare effectiveness of oral Misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy Research hypothesis: Null hypothesis Effectiveness of oral misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy is not different from placebo Alternative hypothesis: : Oral Misoprostal for cervical priming in Premenopausal women underwent to diagnostic hysteroscopy is better than placebo
Detailed description
Research design Randomized double-blinded placebo-controlled trial. The investigators who assess the outcomes and the participants do not know Misoprostal group or control group. The patients are given the random concealed envelop which contains Misoprostal or placebo to take before hysteroscopy. Surgeon and the investigator whom assess patients do not know group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostal group | Experimental | Drug: Misoprostol 200Mcg TabPatients were added oral Misoprostal 200 mcg 2 tab per oral 3 hour before hysteroscopy |
| Placebo group | No intervention | –Patients were take placebo 2 tab per oral 3 hour before hysteroscopy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Premenopausal women
- Patients have following indication for diagnosis hysteroscopy
- Patients provided written informed consent
Key exclusion criteria (9 listed)
- Postmenopausal women
- Patients who have contraindication for Misoprostal as following
- Patients who have contraindication for Hysteroscopoy as following
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 Tabpatient takes 2 tab of 200 mcg of Misoprostal 3 hr before hysteroscopy | Drug | Misoprostal group |
Primary outcome
initial cervical diameter
Time frame: 1 year
The initial hedgar dilator number which can easily insert through cervix
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 22 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 200Mcg Tab in people with Abnormal Uterine Bleeding and Chronic Pelvic Pain, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
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 8 inclusion and 9 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 22 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 Thailand. 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.
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?
initial cervical diameter (time frame: 1 year). 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 22 Oct 2020.