Pain in Diagnostic HysteroscopyNCT01873391
Pain in Diagnostic Hysteroscopy
A study testing Diagnostic hysteroscopy in people with Pain in Diagnostic Hysteroscopy, run by Sandro Gerli at 1 site in Italy.
Trial summary
The objective of this study is to assess which factors influence the pain perceived during diagnostic anesthesia-free hysteroscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Pain in Diagnostic Hysteroscopy
- What is being tested?
- Diagnostic hysteroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 603 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Feb 2014
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female gender
- diagnostic hysteroscopy indication
- italian-speaking patients
Who cannot join
- patients who had previously undergone a diagnostic hysteroscopy
- patients who had been previously undergone to cervical surgery
- ongoing pregnancy
- cervical carcinoma
- pelvic inflammatory disease
- excessive uterine bleeding
- performance of an endometrial biopsy during the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain in Diagnostic Hysteroscopy: a Multivariate Analysis.
The objective of this study is to assess which factors influence the pain perceived during diagnostic anesthesia-free hysteroscopy.
- Conditions
- Pain in Diagnostic Hysteroscopy
- Being tested
- Diagnostic hysteroscopy
- Keywords
- Diagnostic hysteroscopy, Pain, VAS, Multivariate analysis, Normal saline, Carbon dioxide
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic hysteroscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Normal saline | Active comparator | Normal saline is a distension media of uterine cavity in diagnostic hysteroscopy. Receives: Procedure: Diagnostic hysteroscopy |
| Carbon dioxide | Active comparator | Carbon dioxide is a distension media of uterine cavity in diagnostic hysteroscopy. Receives: Procedure: Diagnostic hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of pain during diagnostic hysteroscopy by Visual Analogue Scale.
Measured: 5 minutes after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionFeb 2014
- Study completionFeb 2014
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 Pain in Diagnostic HysteroscopyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 603 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandro Gerli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sandro Gerli, Azienda Ospedaliera S. Maria della Misericordia
- Investigators
- Sandro Gerli, MD, Study director, University Of Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873391
- Sponsor's protocol ID
- co2 vs h2o
- Status last verified
- Feb 2014
- First submitted
- 1 Jun 2013
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mazzon I, Favilli A, Grasso M, Horvath S, Bini V, Di Renzo GC, Gerli S. Pain in diagnostic hysteroscopy: a multivariate analysis after a randomized, controlled trial. Fertil Steril. 2014 Nov;102(5):1398-403. doi: 10.1016/j.fertnstert.2014.07.1249. Epub 2014 Sep 18.
PubMed 25241369
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain in Diagnostic Hysteroscopy: a Multivariate Analysis.
- ClinicalTrials.gov ID
- NCT01873391
- Acronym / sponsor ID
- co2 vs h2o
- Conditions
- Pain in Diagnostic Hysteroscopy
- Keywords
- Diagnostic hysteroscopy, Pain, VAS, Multivariate analysis, Normal saline, Carbon dioxide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 603 participants (actual)
- Lead sponsor
- Sandro GerliUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 10 Jun 2013 (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.
The objective of this study is to assess which factors influence the pain perceived during diagnostic anesthesia-free hysteroscopy.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal saline | Active comparator | Procedure: Diagnostic hysteroscopyNormal saline is a distension media of uterine cavity in diagnostic hysteroscopy. |
| Carbon dioxide | Active comparator | Procedure: Diagnostic hysteroscopyCarbon dioxide is a distension media of uterine cavity in diagnostic hysteroscopy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- female gender
- diagnostic hysteroscopy indication
- italian-speaking patients
Key exclusion criteria (7 listed)
- patients who had previously undergone a diagnostic hysteroscopy
- patients who had been previously undergone to cervical surgery
- ongoing pregnancy
- cervical carcinoma
- pelvic inflammatory disease
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 |
|---|---|---|
| Diagnostic hysteroscopy | Procedure or surgery | Carbon dioxide, Normal saline |
Primary outcome
Evaluation of pain during diagnostic hysteroscopy by Visual Analogue Scale.
Time frame: 5 minutes after the procedure.
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 6 Feb 2014.
- Derived from this study: PubMed 25241369Mazzon I, Favilli A, Grasso M, Horvath S, Bini V, Di Renzo GC, Gerli S. Pain in diagnostic hysteroscopy: a multivariate analysis after a randomized, controlled trial. Fertil Steril. 2014 Nov;102(5):1398-403. doi: 10.1016/j.fertnstert.2014.07.1249. Epub 2014 Sep 18.
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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.
Sandro Gerli, MD study director
University Of Perugia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic hysteroscopy in people with Pain in Diagnostic Hysteroscopy, run by Sandro Gerli at 1 site in Italy.
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 7 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 6 Feb 2014. 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 Italy. 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?
Evaluation of pain during diagnostic hysteroscopy by Visual Analogue Scale. (time frame: 5 minutes after the procedure.). 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 NCT01873391, 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 6 Feb 2014.