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| Name | Class |
|---|---|
| Bedaya Hospital | OTHER |
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The aim of this study is to determine whether full bladder IUD insertion without vulsellum or uterine sound under ultrasound guidance is associated with less pain compared with the standard technique of IUD insertion .
The intrauterine device (IUD) is an effective method of contraception. Pain experienced during IUD insertion is one of the main causes that limits its widespread use.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vulsellum group | Active Comparator | 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. |
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| Ultrasound group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vulsellum group | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of pain | Measured using 100 mm visual analogue scale ( 0 = no pain and 100 = worst possible pain) | Immediately after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Success of IUD insertion | ( number of successfully inserted IUD / total number of IUD insertion attempts) | Immediately after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Usama M Fouda, Prof. | Contact | 01095401375 | +2 | umfrfouda@kasralainy.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Usama M Fouda, Prof. | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine, Cairo university | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36583454 | Background | 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. |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Ultrasound group | Procedure | 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.. |
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