Postoperative InfectionPhase 3PISOHNCT02713074
Povidone-iodine Versus Saline in Vaginal Cleansing Before Office Hysteroscopy
A Phase 3 study testing povidone-iodine and normal saline in people with Postoperative Infection, run by Assiut University at 1 site in Egypt.
Trial summary
The normal saline is used in medicine as an intravenous isotonic infusion and for cleaning wounds. It is a mild but effective cleaning agent and will not harm normal tissue, unlike many stronger antiseptics. It is available and inexpensive in comparison to povidone iodine. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postoperative Infection
- What is being tested?
- povidone-iodine and normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2016to Jul 2017
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1 - All women who will subject to office Hysterosocpy for gynecological problems
Who cannot join
- All patients have current vaginitis or urinary tract infection before the hysteroscopy
- Diabetic women.
- Women with body mass index > 25 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Povidone-iodine and Normal Saline in Vaginal Cleansing Before Office Hysterosocpy: a Randomized Controlled Trial
The normal saline is used in medicine as an intravenous isotonic infusion and for cleaning wounds. It is a mild but effective cleaning agent and will not harm normal tissue, unlike many stronger antiseptics. It is available and inexpensive in comparison to povidone iodine.
- Conditions
- Postoperative Infection
- Being tested
- povidone-iodine, normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
povidone-iodineDrug
The patients will be subjected to povidone-iodine (Betadine7.5%) for vaginal cleaning before office hysteroscopy
normal salineDrug
The patients will be subjected to normal saline (Sod. Chloride 0.9%, Nile) for vaginal cleaning
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | povidone-iodine group Receives: Drug: povidone-iodine |
| Group B | Active comparator | Normal saline group Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of postoperative vaginal irritation symptoms
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 posted18 Mar 2016 (estimated)
- Study startOct 2016
- Primary completionMar 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713074
- Sponsor's protocol ID
- PI-S
- Acronym
- PISOH
- Status last verified
- Jul 2017
- First submitted
- 15 Mar 2016
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Povidone-iodine and Normal Saline in Vaginal Cleansing Before Office Hysterosocpy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02713074
- Acronym / sponsor ID
- PISOH / PI-S
- Conditions
- Postoperative Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 18 Mar 2016 (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 normal saline is used in medicine as an intravenous isotonic infusion and for cleaning wounds. It is a mild but effective cleaning agent and will not harm normal tissue, unlike many stronger antiseptics. It is available and inexpensive in comparison to povidone iodine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: povidone-iodinepovidone-iodine group |
| Group B | Active comparator | Drug: normal salineNormal saline group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1 - All women who will subject to office Hysterosocpy for gynecological problems
Key exclusion criteria (3 listed)
- All patients have current vaginitis or urinary tract infection before the hysteroscopy
- Diabetic women.
- Women with body mass index > 25 kg/m2.
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 |
|---|---|---|
| povidone-iodineThe patients will be subjected to povidone-iodine (Betadine7.5%) for vaginal cleaning before office hysteroscopy | Drug | Group A |
| normal salineThe patients will be subjected to normal saline (Sod. Chloride 0.9%, Nile) for vaginal cleaning | Drug | Group B |
Primary outcome
rate of postoperative vaginal irritation symptoms
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 19 Jul 2017.
- 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.
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 Phase 3 study testing povidone-iodine and normal saline in people with Postoperative Infection, run by Assiut University 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 1 inclusion and 3 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 19 Jul 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 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?
rate of postoperative vaginal irritation symptoms (time frame: 24 hours). 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 19 Jul 2017.