Intrauterine DeviceNCT03383432
Intrauterine Device Insertion: a Step for High Satisfaction
A study testing Intrauterine device, Ultrasound and uterine sounding sparing technique in people with Intrauterine Device, run by Assiut University at 1 site in Egypt.
Trial summary
The intrauterine device is a safe, reliable and long-acting reversible contraceptive method. Instrumentation of lower genital mucosa during intrauterine device application provokes pain because it is highly sensitive to touch. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Intrauterine Device
- What is being tested?
- Intrauterine device, Ultrasound and uterine sounding sparing technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 1 Aug 2020
- 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 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-49 years
- Nonpregnant
- Women did not receive any analgesics or misoprostol in the 24 hours prior to insertion.
Who cannot join
- Women with any uterine abnormalities such as congenital anomalies, endometrial lesions, fibroids
- Allergy to Copper.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Approach Versus Uterine Sound-sparing Approach for Intrauterine Device Insertion a Randomized Clinical Trial
The intrauterine device is a safe, reliable and long-acting reversible contraceptive method. Instrumentation of lower genital mucosa during intrauterine device application provokes pain because it is highly sensitive to touch. Fear of pain associated with intrauterine device insertion is considered a barrier to use this contraception method.
The classic insertion instructions recommend performing bimanual examination and uterine sounding prior to intrauterine device insertion in order to confirm proper determination of uterine size and position. The pain during intrauterine device insertion could be due to cervical grasping by the tenaculum, traction on the cervical canal, stretching of the internal os by the uterine sound or the intrauterine device inserter, and lastly by irritation of the endometrial lining by the intrauterine device.
Read more
Many studies investigated the use of various analgesics in different doses and routes of administration and found out that it has a significant impact on relieving of associated pain Some technical modifications have been emerged in trial to decrease pain during intrauterine device insertion. One of them is trans-abdominal ultrasound guided intrauterine device insertion which the participant with a full bladder is subjected to intrauterine device insertion under ultrasonographic guide without using tenaculum. This method effectively decreased the pain and time of intrauterine device insertion.
A recent method named "Uterine Sounding Sparing Approach" has been reported very recently in literature by Ali et al., 2017. In this method; the sonographer performs T transvaginal ultrasound to evaluate the uterine position and the endometrial length in the sagittal view of the uterus. The intrauterine device was inserted directly into the uterine cavity without using uterine sounding.
In spite of less pain reported by trans-abdominal ultrasound guided intrauterine device insertion (no vulsellum was used), this methods also have some drawbacks, firstly; the full bladder may displace the cervix upward making the intrauterine device application not quite easy and secondly; this method needs two investigators which may distress the women who wondering about this. These two drawbacks may decrease patient's and physician's satisfaction. The uterine sounding sparing approach lacks these two drawbacks which make it more satisfying.
From above evidence, there is a strong need to compare the satisfaction rate between the two mentioned approaches in trial to answer this question. Up to our knowledge; no randomized trial has been conducted or registered to compare the satisfaction rate between two above approaches.
- Conditions
- Intrauterine Device
- Being tested
- Intrauterine device, Ultrasound, uterine sounding sparing technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine deviceDevice
Copper T 380 A
UltrasoundRadiation
Transabdominal ultrasound
uterine sounding sparing techniqueProcedure or surgery
we will insert intrauterine device without using the uterine sound and we will replace this step by ultrasound before insertion
| Study group | Role | What they receive |
|---|---|---|
| Trans-abdominal ultrasound intrauterine device group. | Other | Those will be subjected to intrauterine device insertion under trans-abdominal ultrasound guidance. In this method the participant will be asked to have a full bladder. Full bladder helps to displace the bowel out of the pelvis and acts as an acoustic window for high frequency sound waves and to straighten the angle between the uterine body and cervix in anteverted uterus, performing the function of the tenaculum. Then, then ultrasound will be done and the intrauterine device will be introduced vaginally under ultrasound vision. Receives: Device: Intrauterine device; Radiation: Ultrasound |
| Uterine Sounding Sparing intrauterine device group | Other | The sonographer performs ultrasound using transvaginal probe to evaluate the uterine position and the endometrial length in the sagittal view of the uterus. The intrauterine device was inserted directly into the uterine cavity without using uterine sounding. Receives: Device: Intrauterine device; Procedure: uterine sounding sparing technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of satisfaction of patients in both groups (satisfaction score)
Measured by visual analogue like scale from 0 to 10
Measured: 5 minutes after intrauterine device insertion
Secondary outcomes (1)
Level of reported pain (visual analogue scale )
Measured: 5 minutes after intrauterine device insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start1 Jun 2019
- Primary completion1 Jun 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine DeviceStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 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
- NCT03383432
- Sponsor's protocol ID
- IUD-TAUSSA
- Status last verified
- Feb 2021
- First submitted
- 19 Dec 2017
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Approach Versus Uterine Sound-sparing Approach for Intrauterine Device Insertion a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03383432
- Acronym / sponsor ID
- IUD-TAUSSA
- Conditions
- Intrauterine Device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 26 Dec 2017 (actual)
- 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 device is a safe, reliable and long-acting reversible contraceptive method. Instrumentation of lower genital mucosa during intrauterine device application provokes pain because it is highly sensitive to touch. Fear of pain associated with intrauterine device insertion is considered a barrier to use this contraception method.
The classic insertion instructions recommend performing bimanual examination and uterine sounding prior to intrauterine device insertion in order to confirm proper determination of uterine size and position. The pain during intrauterine device insertion could be due to cervical grasping by the tenaculum, traction on the cervical canal, stretching of the internal os by the uterine sound or the intrauterine device inserter, and lastly by irritation of the endometrial lining by the intrauterine device.
Many studies investigated the use of various analgesics in different doses and routes of administration and found out that it has a significant impact on relieving of associated pain Some technical modifications have been emerged in trial to decrease pain during intrauterine device insertion. One of them is trans-abdominal ultrasound guided intrauterine device insertion which the participant with a full bladder is subjected to intrauterine device insertion under ultrasonographic guide without using tenaculum. This method effectively decreased the pain and time of intrauterine device insertion.
A recent method named "Uterine Sounding Sparing Approach" has been reported very recently in literature by Ali et al., 2017. In this method; the sonographer performs T transvaginal ultrasound to evaluate the uterine position and the endometrial length in the sagittal view of the uterus. The intrauterine device was inserted directly into the uterine cavity without using uterine sounding.
In spite of less pain reported by trans-abdominal ultrasound guided intrauterine device insertion (no vulsellum was used), this methods also have some drawbacks, firstly; the full bladder may displace the cervix upward making the intrauterine device application not quite easy and secondly; this method needs two investigators which may distress the women who wondering about this. These two drawbacks may decrease patient's and physician's satisfaction. The uterine sounding sparing approach lacks these two drawbacks which make it more satisfying.
From above evidence, there is a strong need to compare the satisfaction rate between the two mentioned approaches in trial to answer this question. Up to our knowledge; no randomized trial has been conducted or registered to compare the satisfaction rate between two above approaches.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trans-abdominal ultrasound intrauterine device group. | Other | Device: Intrauterine device, Radiation: UltrasoundThose will be subjected to intrauterine device insertion under trans-abdominal ultrasound guidance. In this method the participant will be asked to have a full bladder. Full bladder helps to displace the bowel out of the pelvis and acts as an acoustic window for high frequency sound waves and to straighten the angle between the uterine body and cervix in anteverted uterus, performing the function of the tenaculum. Then, then ultrasound will be done and the intrauterine device will be introduced vaginally under ultrasound vision. |
| Uterine Sounding Sparing intrauterine device group | Other | Device: Intrauterine device, Procedure: uterine sounding sparing techniqueThe sonographer performs ultrasound using transvaginal probe to evaluate the uterine position and the endometrial length in the sagittal view of the uterus. The intrauterine device was inserted directly into the uterine cavity without using uterine sounding. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women aged 18-49 years
- Nonpregnant
- Women did not receive any analgesics or misoprostol in the 24 hours prior to insertion.
Key exclusion criteria (2 listed)
- Women with any uterine abnormalities such as congenital anomalies, endometrial lesions, fibroids
- Allergy to Copper.
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 deviceCopper T 380 A | Device | Trans-abdominal ultrasound intrauterine device group., Uterine Sounding Sparing intrauterine device group |
| UltrasoundTransabdominal ultrasound | Radiation | Trans-abdominal ultrasound intrauterine device group. |
| uterine sounding sparing techniquewe will insert intrauterine device without using the uterine sound and we will replace this step by ultrasound before insertion | Procedure or surgery | Uterine Sounding Sparing intrauterine device group |
Primary outcome
Level of satisfaction of patients in both groups (satisfaction score)
Time frame: 5 minutes after intrauterine device insertion
Measured by visual analogue like scale from 0 to 10
1 secondary outcome
Level of reported pain (visual analogue scale )
Time frame: 5 minutes after intrauterine device insertion
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 10 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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 study testing Intrauterine device, Ultrasound and uterine sounding sparing technique in people with Intrauterine Device, 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 3 inclusion and 2 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 10 Feb 2021. 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?
Level of satisfaction of patients in both groups (satisfaction score) (time frame: 5 minutes after intrauterine device insertion). 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 10 Feb 2021.