ContraceptionNCT02582268
A Novel IUD Insertion Technique
A study testing intrauterine device TCu 380A and Trans-abdominal sonography in people with Contraception, run by Woman's Health University Hospital, Egypt at 1 site in Egypt.
Trial summary
A previous trial performed by our research team, in order to reduce the pain associated with intrauterine device insertion, compared the novel technique of IUD insertion under the guidance of the trans-abdominal sonography to the traditional method of IUD insertion. 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 and Trans-abdominal sonography
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2015to Feb 2016
- 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
- Females with history of previous vaginal delivery
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 12Show 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr el aini hospital
Cairo, Cairo Governorate, 12211
Dina M Dakhly, MD, 01003498919 ext. 002, Dinadakhly@gmail.com
Dina M Dakhly, MD
About this study
Official title: Introducing Trans- Abdominal Guided Intrauterine Device Insertion, a Single Blinded Randomized Control Trial
A previous trial performed by our research team, in order to reduce the pain associated with intrauterine device insertion, compared the novel technique of IUD insertion under the guidance of the trans-abdominal sonography to the traditional method of IUD insertion. It came up with the conclusion that the TAS guided IUD insertion is significantly lower in pain score and time taken for insertion, when compared with the traditional method. In this study our researchers aim to abolish the distracting effect of the technician and the TAS probe (which might have interfered with previous results).
- Conditions
- Contraception
- Being tested
- intrauterine device TCu 380A, Trans-abdominal sonography
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
Trans-abdominal sonographyRadiation
Also called TAS
| Study group | Role | What they receive |
|---|---|---|
| TAS guided IUD insertion | 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; Radiation: Trans-abdominal sonography |
| Traditional IUD insertion | Experimental | the intrauterine device TCu 380A will be inserted in the conventional method, and checked afterwards by transvaginal ultrasound. the trans-abdominal probe will also be placed by an assistant on the suprapubic region ( the image would be on freeze mode) as it is not actually used , it is just to make the same settings for the participant females. Receives: Device: intrauterine device TCu 380A |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of pain during IUD insertion
Pain will be assessed by the use of visual analog scale (VAS).
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
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 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
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 M Dakhly, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582268
- Sponsor's protocol ID
- CU151020
- Status last verified
- Oct 2015
- First submitted
- 16 Oct 2015
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dakhly DMR, Bassiouny YA. Ultrasound-guided intrauterine device insertion: a step closer to painless insertion: a randomized control trial. Eur J Contracept Reprod Health Care. 2017 Oct;22(5):349-353. doi: 10.1080/13625187.2017.1381234. Epub 2017 Oct 5.
PubMed 28978240
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introducing Trans- Abdominal Guided Intrauterine Device Insertion, a Single Blinded Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02582268
- Acronym / sponsor ID
- CU151020
- Conditions
- Contraception
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Woman's Health University Hospital, EgyptUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 21 Oct 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.
A previous trial performed by our research team, in order to reduce the pain associated with intrauterine device insertion, compared the novel technique of IUD insertion under the guidance of the trans-abdominal sonography to the traditional method of IUD insertion. It came up with the conclusion that the TAS guided IUD insertion is significantly lower in pain score and time taken for insertion, when compared with the traditional method. In this study our researchers aim to abolish the distracting effect of the technician and the TAS probe (which might have interfered with previous results).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAS guided IUD insertion | Experimental | Device: intrauterine device TCu 380A, Radiation: Trans-abdominal sonographythe 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. |
| Traditional IUD insertion | Experimental | Device: intrauterine device TCu 380Athe intrauterine device TCu 380A will be inserted in the conventional method, and checked afterwards by transvaginal ultrasound. the trans-abdominal probe will also be placed by an assistant on the suprapubic region ( the image would be on freeze mode) as it is not actually used , it is just to make the same settings for the participant females. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Females desiring contraception with the use of IUD
- Females with history of previous vaginal delivery
Key exclusion criteria (12 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 | TAS guided IUD insertion, Traditional IUD insertion |
| Trans-abdominal sonographyAlso: TAS | Radiation | TAS guided IUD insertion |
Primary outcome
degree of pain during IUD insertion
Time frame: 4 months
Pain will be assessed by the use of visual analog scale (VAS).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
- Derived from this study: PubMed 28978240Dakhly DMR, Bassiouny YA. Ultrasound-guided intrauterine device insertion: a step closer to painless insertion: a randomized control trial. Eur J Contracept Reprod Health Care. 2017 Oct;22(5):349-353. doi: 10.1080/13625187.2017.1381234. Epub 2017 Oct 5.
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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 M 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 and Trans-abdominal sonography 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 2 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 21 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina M Dakhly, MD (01003498919 ext. 002, dinadakhly@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of pain during IUD insertion (time frame: 4 months). 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 NCT02582268, 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 21 Oct 2015.