Contraceptive Device; ComplicationsNCT06550544
Hysteroscopic Guided Versus Ultrasound Guided Extraction of Retained IUD
A study testing Office hysteroscopy and Ultrasound guided in people with Contraceptive Device; Complications, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this randomized controlled study is to compare the pain experienced during extraction of retained IUD by office hysteroscopy with the pain experienced during extraction of retained IUD under ultrasound guidance . Moreover, the success of both procedures was compared. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Contraceptive Device; Complications
- What is being tested?
- Office hysteroscopy and Ultrasound guided
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Aug 2024to 21 Feb 2025
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with retained IUD
Who cannot join
- Active pelvic infection
- Viable intrauterine pregnancy
- Cervical pathology
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university
Cairo
About this study
Official title: Hysteroscopic Guided Versus Ultrasound Guided Extraction of Retained IUD A Randomized Controlled Study
The aim of this randomized controlled study is to compare the pain experienced during extraction of retained IUD by office hysteroscopy with the pain experienced during extraction of retained IUD under ultrasound guidance . Moreover, the success of both procedures was compared. Various subgroups (patients who delivered only by Caesarean section, patients who delivered virginally, nulliparous women and menopausal patients) in both groups are compared.
Read the detailed description
The intrauterine device (IUD) is a commonly used long-acting, effective and reversible method of contraception. The recommended way to remove a IUD is by grasping the threads with forceps and applying gentle traction until the IUD is extracted from the external os.
Absent of the threads at the time of IUD removal is reported in 4.5 to 18% of cases. If the IUD is present in the uterus and threads are not visible , its removal in the office setting can still be achieved in about 80% of patients with the use of alligator forceps or string retrieval devices, hooks or clamps. However, blind manipulation may cause uterine perforation . In cases where such devices have failed (retained IUD ), If in office extraction of IUD by these instruments failed, removal of this retained IUD in the operating room is often employed because cervical dilatation and regional or general anesthesia are needed.
In the last decade, several studies reported in office extraction of retained IUD by office hysteroscopy or under ultrasound guidance. No studies compared the efficacy or safety of these procedures
- Conditions
- Contraceptive Device; Complications
- Being tested
- Office hysteroscopy, Ultrasound guided
- Keywords
- IUD, Office hysteroscopy, Ultrasound, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Office hysteroscopyProcedure or surgery
A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. Vaginoscopic approach will be used. A 5 F grasper will be used to grasp and extract the IUD.
Pain intensity will be assessed by visual analogue scale immediately after the procedure.
Ultrasound guidedProcedure or surgery
An alligator forceps will be introduced into the uterine cavity under ultrasound sound guidance. The IUD will be grasped and extracted outside the uterus.
Pain intensity will be assessed by visual analogue scale immediately after the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Office hysteroscopy | Active comparator | A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. Vaginoscopic approach will be used. A 5 F grasper will be used to grasp and extract the IUD.
.Pain intensity will be assessed by visual analogue scale immediately after the procedure. Receives: Procedure: Office hysteroscopy |
| Ultrasound guided | Active comparator | An alligator forceps will be introduced into the uterine cavity under ultrasound sound guidance. The IUD will be grasped and extracted outside the uterus.
.Pain intensity will be assessed by visual analogue scale immediately after the procedure. Receives: Procedure: Ultrasound guided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain
Measured after the procedure using a 10 cm Visual analogue scale ( where 0 indicates no pain') and 10 indicates a 'pain as bad as it could possibly be')
Measured: Immediately after the procedure
Secondary outcomes (1)
Success of IUD extraction
Percentage of successfully extracted IUD (number of extracted IUDs / total number of retained IUDs)
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start21 Aug 2024 (estimated)
- Primary completion20 Feb 2025 (estimated)
- Study completion21 Feb 2025 (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 Contraceptive Device; ComplicationsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Bedaya Hospital
- Responsible party
- Principal investigator, Usama M Fouda, Cairo University
- Investigators
- Usama M Fouda, Prof., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550544
- Sponsor's protocol ID
- Retained IUD/Hysteroscopy/US
- Status last verified
- Aug 2024
- First submitted
- 11 Apr 2024
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Townsend L, Luxford E, Mizia K. Effectiveness of ultrasound-guided removal of intrauterine devices. Aust N Z J Obstet Gynaecol. 2022 Oct;62(5):800-802. doi: 10.1111/ajo.13584. Epub 2022 Jul 11.
PubMed 35815357
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hysteroscopic Guided Versus Ultrasound Guided Extraction of Retained IUD A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06550544
- Acronym / sponsor ID
- Retained IUD/Hysteroscopy/US
- Conditions
- Contraceptive Device; Complications
- Keywords
- IUD, Office hysteroscopy, Ultrasound, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Bedaya Hospital
- Study start
- 21 Aug 2024 (estimated)
- Primary completion
- 20 Feb 2025 (estimated)
- Study completion
- 21 Feb 2025 (estimated)
- First posted
- 13 Aug 2024 (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 aim of this randomized controlled study is to compare the pain experienced during extraction of retained IUD by office hysteroscopy with the pain experienced during extraction of retained IUD under ultrasound guidance . Moreover, the success of both procedures was compared. Various subgroups (patients who delivered only by Caesarean section, patients who delivered virginally, nulliparous women and menopausal patients) in both groups are compared.
Detailed description
The intrauterine device (IUD) is a commonly used long-acting, effective and reversible method of contraception. The recommended way to remove a IUD is by grasping the threads with forceps and applying gentle traction until the IUD is extracted from the external os.
Absent of the threads at the time of IUD removal is reported in 4.5 to 18% of cases. If the IUD is present in the uterus and threads are not visible , its removal in the office setting can still be achieved in about 80% of patients with the use of alligator forceps or string retrieval devices, hooks or clamps. However, blind manipulation may cause uterine perforation . In cases where such devices have failed (retained IUD ), If in office extraction of IUD by these instruments failed, removal of this retained IUD in the operating room is often employed because cervical dilatation and regional or general anesthesia are needed.
In the last decade, several studies reported in office extraction of retained IUD by office hysteroscopy or under ultrasound guidance. No studies compared the efficacy or safety of these procedures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Office hysteroscopy | Active comparator | Procedure: Office hysteroscopyA rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. Vaginoscopic approach will be used. A 5 F grasper will be used to grasp and extract the IUD. .Pain intensity will be assessed by visual analogue scale immediately after the procedure. |
| Ultrasound guided | Active comparator | Procedure: Ultrasound guidedAn alligator forceps will be introduced into the uterine cavity under ultrasound sound guidance. The IUD will be grasped and extracted outside the uterus. .Pain intensity will be assessed by visual analogue scale immediately after the procedure. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with retained IUD
Key exclusion criteria (3 listed)
- Active pelvic infection
- Viable intrauterine pregnancy
- Cervical pathology
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 |
|---|---|---|
| Office hysteroscopyA rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. Vaginoscopic approach will be used. A 5 F grasper will be used to grasp and extract the IUD. Pain intensity will be assessed by visual analogue scale immediately after the procedure. | Procedure or surgery | Office hysteroscopy |
| Ultrasound guidedAn alligator forceps will be introduced into the uterine cavity under ultrasound sound guidance. The IUD will be grasped and extracted outside the uterus. Pain intensity will be assessed by visual analogue scale immediately after the procedure. | Procedure or surgery | Ultrasound guided |
Primary outcome
Intensity of pain
Time frame: Immediately after the procedure
Measured after the procedure using a 10 cm Visual analogue scale ( where 0 indicates no pain') and 10 indicates a 'pain as bad as it could possibly be')
1 secondary outcome
Success of IUD extraction
Time frame: Immediately after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Background: PubMed 35815357Townsend L, Luxford E, Mizia K. Effectiveness of ultrasound-guided removal of intrauterine devices. Aust N Z J Obstet Gynaecol. 2022 Oct;62(5):800-802. doi: 10.1111/ajo.13584. Epub 2022 Jul 11.
- Individual participant dataSharing planned: No
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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.
Usama M Fouda, Prof. 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 Office hysteroscopy and Ultrasound guided in people with Contraceptive Device; Complications, run by Cairo 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 1 inclusion and 3 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 13 Aug 2024. 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 Usama M Fouda, Prof. (01095401375 ext. +2, umfrfouda@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of pain (time frame: Immediately after the procedure). 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 NCT06550544, 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 13 Aug 2024.