ContraceptionNCT02582281
Non Touch Technique for IUD 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
The non touch technique is a modification of the traditional intrauterine device insertion technique. It abolishes the use of Allis and uterine sounding. 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
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2015to Mar 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
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.
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: The Non Touch Technique for Intrauterine Device Insertion, a Single Blinded Randomized Control Trial
The non touch technique is a modification of the traditional intrauterine device insertion technique. It abolishes the use of Allis and uterine sounding.
- 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 |
|---|---|---|
| Non touch technique | Experimental | the intrauterine device TCu 380A will be inserted in the conventional method as follows: First, insert the speculum and view the cervix. The position of the cervix will very often confirm if the uterus is anteverted or retroverted. Second, using the Allis forceps hold the back of a cotton-ball swab and dip it into a povidine-iodine disinfectant solution, or equivalent. Swab the cervix. Then cut the threads to the appropriate length and remove the speculum.
This technique omits the sounding of the uterus which is considered a quintessential procedure before IUD insertion for which there is no one established piece of evidence.The IUD is checked afterwards by transvaginal ultrasound. Receives: Device: intrauterine device TCu 380A |
| Traditional IUD insertion | 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.
degree of pain during IUD insertion
Pain will be assessed by the use of visual analog scale (VAS).
Measured: 5 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 completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
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
- 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
- NCT02582281
- Sponsor's protocol ID
- CU161020
- Status last verified
- Oct 2015
- First submitted
- 16 Oct 2015
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
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
- The Non Touch Technique for Intrauterine Device Insertion, a Single Blinded Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02582281
- Acronym / sponsor ID
- CU161020
- 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
- Mar 2016 (estimated)
- Study completion
- Mar 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.
The non touch technique is a modification of the traditional intrauterine device insertion technique. It abolishes the use of Allis and uterine sounding.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non touch technique | Experimental | Device: intrauterine device TCu 380Athe intrauterine device TCu 380A will be inserted in the conventional method as follows: First, insert the speculum and view the cervix. The position of the cervix will very often confirm if the uterus is anteverted or retroverted. Second, using the Allis forceps hold the back of a cotton-ball swab and dip it into a povidine-iodine disinfectant solution, or equivalent. Swab the cervix. Then cut the threads to the appropriate length and remove the speculum. This technique omits the sounding of the uterus which is considered a quintessential procedure before IUD insertion for which there is no one established piece of evidence.The IUD is checked afterwards by transvaginal ultrasound. |
| 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. |
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 touch technique, Traditional IUD insertion |
Primary outcome
degree of pain during IUD insertion
Time frame: 5 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.
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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 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: 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: 5 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 21 Oct 2015.