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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A01966-43 | Other Identifier | ANSM |
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Intrauterine devices (IUDs) are contraceptive methods of long-acting (from 3 to 10 years depending on the model) and among the most effective. However, there are many obstacles to the use of IUDs including pain felt by patients during installation. Several medical means were studied without evidence of their efficacy in pain related to IUD insertion. In order to remove this brake, it's important to find another way to act against this pain. The direct technique is one of the techniques described by health professionals. It seems trusted by its users as a more reliable technique but also less painful for patients. However, there is no study available on its evaluation. The aim of this study is to investigate the interest of the direct technique in reducing the pain experienced by patients during installation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional technique | Sham Comparator | Intrauterine device (IUD) insertion by the conventional technique |
|
| Direct technique | Experimental | Intrauterine device (IUD) insertion by the direct technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IUD | Device | copper IUD or levonogestrel IUD insert by the conventional technique or by direct technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain measured by Verbal Numeric Scale | Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be) | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Number of failure laying direct technique | intraoperative | |
| Number of vagal discomfort | intraoperative | |
| Number of expulsion of the IUD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Céline Chauleur, PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Saint-Etienne | Saint-Etienne | 42055 | France |
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| intraoperative |
| Number of IUD-fond uterine distance >2 cm | intraoperative |
| Number of expulsion of IUD | up to 7 days |
| Number of emergency department visit for a IUD complication | up to 7 days |
| Number of analgesic intake | up to 7 days post-insertion |
| Pain measured by Verbal Numeric Scale | Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be) | day 1 |
| Pain measured by Verbal Numeric Scale | Pain is score by Verbal Numeric Scale : 0-10 (0 = no pain; 10= pain as bad as can be) | day 7 |