ContraceptionPhase 2NCT02841826
Evaluation of a Novel and Simplified Technique for Intrauterine Contraceptive Devices Insertion: a Prospective Cohort Study
A Phase 2 study testing IUD, Uterine sounding and Transvaginal ultrasound in people with Contraception, run by Assiut University at 1 site in Egypt.
Trial summary
The intrauterine devices (IUDs) are a safe, reliable, long-acting and reversible contraceptive method. It is also sound safe and cheap contraceptive methods available and is nearly maintenance free for up to 10 years. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Contraception
- What is being tested?
- IUD, Uterine sounding and Transvaginal ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Jul 2016
- Phase
- Phase 2
- 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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women requesting intrauterine contraceptive device as a contraction
- Women accepted participation in the study
Who cannot join
- Uterine abnormalities
- Endometrial lesions as polyp
- Adenomyosis
- Fibroids distorting the cavity
- Intrauterine adhesions.
- Chronic pelvic pain
- Dysmenorrhea
- History of cervical surgery
Trial locations and contacts
1 site in 1 country.
About this study
The intrauterine devices (IUDs) are a safe, reliable, long-acting and reversible contraceptive method. It is also sound safe and cheap contraceptive methods available and is nearly maintenance free for up to 10 years.
The fear and the pain associated with IUDs insertion consider barriers to using this contraception method, this is because that the mucosal lining of female genital tract is highly sensitive to touch and pain. However; most of small procedures done in this sensitive area are performed without analgesia.
The pain during IUDs insertion is due to application of the tenaculum , traction of the cervical canal, passing the uterine sound, insertion of the IUDs through the cervix, and irritation of the endometrial lining by the IUDs.
- Conditions
- Contraception
- Being tested
- IUD, Uterine sounding, Transvaginal ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUDOther
Uterine soundingOther
Transvaginal ultrasoundRadiation
| Study group | Role | What they receive |
|---|---|---|
| Group I: IUD without uterine sound group | Other | Transvaginal ultrasound before to intrauterine contraceptive device insertion without uterine sounding. Receives: Other: IUD; Radiation: Transvaginal ultrasound |
| Group II: IUD with uterine sound | Other | Intrauterine contraceptive device inserted by classic method Receives: Other: IUD; Other: Uterine sounding |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of pain perception measured visual analogue score
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khairy Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02841826
- Sponsor's protocol ID
- PIUD
- Status last verified
- Nov 2016
- First submitted
- 20 Jul 2016
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel and Simplified Technique for Intrauterine Contraceptive Devices Insertion: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02841826
- Acronym / sponsor ID
- PIUD
- Conditions
- Contraception
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 22 Jul 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 intrauterine devices (IUDs) are a safe, reliable, long-acting and reversible contraceptive method. It is also sound safe and cheap contraceptive methods available and is nearly maintenance free for up to 10 years.
The fear and the pain associated with IUDs insertion consider barriers to using this contraception method, this is because that the mucosal lining of female genital tract is highly sensitive to touch and pain. However; most of small procedures done in this sensitive area are performed without analgesia.
The pain during IUDs insertion is due to application of the tenaculum , traction of the cervical canal, passing the uterine sound, insertion of the IUDs through the cervix, and irritation of the endometrial lining by the IUDs.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I: IUD without uterine sound group | Other | Other: IUD, Radiation: Transvaginal ultrasoundTransvaginal ultrasound before to intrauterine contraceptive device insertion without uterine sounding. |
| Group II: IUD with uterine sound | Other | Other: IUD, Other: Uterine soundingIntrauterine contraceptive device inserted by classic method |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women requesting intrauterine contraceptive device as a contraction
- Women accepted participation in the study
Key exclusion criteria (8 listed)
- Uterine abnormalities
- Endometrial lesions as polyp
- Adenomyosis
- Fibroids distorting the cavity
- Intrauterine adhesions.
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 |
|---|---|---|
| IUD | Other | Group I: IUD without uterine sound group, Group II: IUD with uterine sound |
| Uterine sounding | Other | Group II: IUD with uterine sound |
| Transvaginal ultrasound | Radiation | Group I: IUD without uterine sound group |
Primary outcome
The degree of pain perception measured visual analogue score
Time frame: 15 minutes
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 25 Nov 2016.
- Individual participant dataSharing planned: Yes
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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 2 study testing IUD, Uterine sounding and Transvaginal ultrasound in people with Contraception, 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 2 inclusion and 8 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 25 Nov 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The degree of pain perception measured visual analogue score (time frame: 15 minutes). 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 25 Nov 2016.