ContraceptionNCT02393495
Ultrasound Guided Intra-uterine Device Insertion
A study testing intrauterine device TCu 380A in people with Contraception, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial summary
Different studies have been made in an attempt to reduce the pain and the duration of the process of outpatient insertion of the intrauterine device. in this trial, the investigators aim to insert the IUD under ultrasonographic guidance, which can help to reduce the pain, decrease the process of insertion, in… Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Contraception
- What is being tested?
- intrauterine device TCu 380A
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2015to Aug 2015
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females desiring contraception with the use of IUD
Who cannot join
- Are pregnant or think they may be pregnant
- Septic pregnancy or abortion
- Have unexplained abnormal vaginal bleeding
- Have untreated cervical cancer
- Have malignant gestational trophoblastic disease
- Have uterine cancer
Show all 14Show fewer
- Have uterine abnormalities
- Have or may have had a pelvic infection within the past three months
- Have or may have any sexually transmitted disease
- Have pelvic tuberculosis
- Are postpartum between 48 hours and 4 weeks
- Have benign gestational trophoblastic disease
- Have ovarian cancer
- Have AIDS (unless clinically well on anti-retroviral therapy)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Further Step Towards Painless Intrauterine Device Insertion, a Randomized Control Trial
Different studies have been made in an attempt to reduce the pain and the duration of the process of outpatient insertion of the intrauterine device. in this trial, the investigators aim to insert the IUD under ultrasonographic guidance, which can help to reduce the pain, decrease the process of insertion, in addition, it reduces the incidence of malposition of IUD as well as the risk of complications.
- Conditions
- Contraception
- Being tested
- intrauterine device TCu 380A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrauterine device TCu 380ADevice
Also called TCu 380A
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound guided group | Experimental | the female will be asked to be full bladder. the trans-abdominal probe will be placed by an assistant on the suprapubic region. under speculum examination, the intrauterine device IUD (TCu 380A) will be placed till it reaches the fundus of the uterus and then released. Receives: Device: intrauterine device TCu 380A |
| Non ultrasound guided group | Experimental | the intrauterine device TCu 380A will be inserted in the conventional method, and checked afterwards by transvaginal ultrasound. Receives: Device: intrauterine device TCu 380A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of degree of pain during IUD insertion
Pain will be assessed by the use of visual analog scale, Pain rating scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionAug 2015
- Study completionAug 2015
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's Health University Hospital, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mohamed Refaat Dakhly, Woman's Health University Hospital, Egypt
- Investigators
- Dina MR Dakhly, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393495
- Sponsor's protocol ID
- 22012015
- Status last verified
- Aug 2015
- First submitted
- 23 Jan 2015
- Last updated
- 1 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Further Step Towards Painless Intrauterine Device Insertion, a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02393495
- Acronym / sponsor ID
- 22012015
- Conditions
- Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 19 Mar 2015 (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.
Different studies have been made in an attempt to reduce the pain and the duration of the process of outpatient insertion of the intrauterine device. in this trial, the investigators aim to insert the IUD under ultrasonographic guidance, which can help to reduce the pain, decrease the process of insertion, in addition, it reduces the incidence of malposition of IUD as well as the risk of complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound guided group | Experimental | Device: intrauterine device TCu 380Athe female will be asked to be full bladder. the trans-abdominal probe will be placed by an assistant on the suprapubic region. under speculum examination, the intrauterine device IUD (TCu 380A) will be placed till it reaches the fundus of the uterus and then released. |
| Non ultrasound guided group | Experimental | Device: intrauterine device TCu 380Athe intrauterine device TCu 380A will be inserted in the conventional method, and checked afterwards by transvaginal ultrasound. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Females desiring contraception with the use of IUD
Key exclusion criteria (14 listed)
- Are pregnant or think they may be pregnant
- Septic pregnancy or abortion
- Have unexplained abnormal vaginal bleeding
- Have untreated cervical cancer
- Have malignant gestational trophoblastic 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 |
|---|---|---|
| intrauterine device TCu 380AAlso: TCu 380A | Device | Non ultrasound guided group, Ultrasound guided group |
Primary outcome
Assessment of degree of pain during IUD insertion
Time frame: 6 months
Pain will be assessed by the use of visual analog scale, Pain rating scale
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 1 Sep 2015.
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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.
Dina MR Dakhly, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intrauterine device TCu 380A in people with Contraception, run by Woman's Health University Hospital, Egypt 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 14 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 1 Sep 2015. 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.
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?
Assessment of degree of pain during IUD insertion (time frame: 6 months). 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 1 Sep 2015.