Full Bladder IUD Insertion Without Vulsellum Under Ultrasound Guidance
NCT ID: NCT06554249
Last Updated: 2024-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
82 participants
INTERVENTIONAL
2024-10-15
2025-06-15
Brief Summary
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Detailed Description
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Pain during IUD insertion is caused by insertion of cusco vaginal speculum, sounding the uterus, application of vulsellum to grasp the cervix, the passage of the inserter tube through the cervical canal and uterine cavity..
In order to minimize the pain associated with IUD insertion , several studies reported that the use of ultrasound to guide the insertion of IUD into uterine cavity was associated with less pain and more accurate placement of IUD, other studies reported that filling the bladder during IUD insertion minimized the pain associated with IUD insertion.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Vulsellum group
The patients are asked to empty the bladder before IUD insertion. The vulsellum is applied on the cervix, sounding of the uterus is done and the IUD is inserted according to the standard technique of IUD insertion.
Pain intensity is assessed after the procedure using a visual analogue scale.
Vulsellum group
The patients are asked to empty the bladder before IUD insertion. The vulsellum is applied on the cervix, sounding of the uterus is done and the IUD is inserted according to the standard technique of IUD insertion.
Pain intensity is assessed after the procedure using a visual analogue scale.
Ultrasound group
During the two hour period before IUD insertion, the patients are asked to drink about one liter of water and to avoid micturition.
Abdominal ultrasound is used to obtain a sagittal view of the uterus and the IUD is introduced into the uterine cavity under ultrasound guidance.
The vulsellum and uterine sound are not used during IUD insertion. Pain intensity is assessed after the procedure using a visual analogue scale.
Ultrasound group
During the two hour period before IUD insertion, the patients are asked to drink about one liter of water and to avoid micturition.
Abdominal ultrasound is used to obtain a sagittal view of the uterus and the IUD is introduced into the uterine cavity under ultrasound guidance.
The vulsellum and uterine sound are not used during IUD insertion. Pain intensity is assessed after the procedure using a visual analogue scale..
Interventions
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Vulsellum group
The patients are asked to empty the bladder before IUD insertion. The vulsellum is applied on the cervix, sounding of the uterus is done and the IUD is inserted according to the standard technique of IUD insertion.
Pain intensity is assessed after the procedure using a visual analogue scale.
Ultrasound group
During the two hour period before IUD insertion, the patients are asked to drink about one liter of water and to avoid micturition.
Abdominal ultrasound is used to obtain a sagittal view of the uterus and the IUD is introduced into the uterine cavity under ultrasound guidance.
The vulsellum and uterine sound are not used during IUD insertion. Pain intensity is assessed after the procedure using a visual analogue scale..
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Viable intrauterine pregnancy
* Uterine anomalies
* Uterine fibroid
* Wilson disease
18 Years
48 Years
FEMALE
No
Sponsors
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Bedaya Hospital
OTHER
Cairo University
OTHER
Responsible Party
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Usama M Fouda
Prof.
Principal Investigators
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Usama M Fouda, Prof.
Role: PRINCIPAL_INVESTIGATOR
Cairo University
Locations
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Faculty of medicine, Cairo university
Cairo, , Egypt
Countries
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Central Contacts
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References
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Baradwan S, Alshahrani MS, Alnoury A, Khadawardi K, Khan MA, Abdelkader RAA, Saleh OI, Galal HM, Mohamed SMA, Abdelhakim AM, Elgedawy AM, Elbahie AM, Gaber MA, Magdy AA, Shaheen K. Does Ultrasound Guidance Provide Pain Relief During Intrauterine Contraceptive Device Insertion? A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Ultrasound Med. 2023 Jul;42(7):1401-1411. doi: 10.1002/jum.16166. Epub 2022 Dec 30.
Other Identifiers
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IUD/Ultrasound
Identifier Type: -
Identifier Source: org_study_id
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