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To investigate whether vaginal isonicotinic acid hydrazide administered before the levonorgestrel-releasing intrauterine system insertion reduces IUD insertion pain and difficulty in insertion in adolescents and young women.
Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INH | Experimental | 3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion. |
|
| Placebo Comparator | Placebo Comparator | 3 tablet of placebo self-administered by the patient 12 hours before IUD insertion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INH | Drug | 3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference in pain scores during intrauterine device insertion | The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10 | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| duration of IUD insertion | duration of IUD insertion measured in minutes | 10 minutes |
| Provider ease of insertion | Provider ease of insertion was evaluated using a visual analog scale from 0 to 10 cm where 0 denotes very easy insertion and 10 denotes a very difficult insertion. |
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Inclusion Criteria:
Exclusion Criteria:
adolescents and young women.
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| Name | Affiliation | Role |
|---|---|---|
| nahla w Shady, md | Aswan universirty | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University Hospital | Aswān | 81528 | Egypt |
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double blind randomized controlled study
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double blind randomized controlled study
| Placebo Comparator | Drug | 3 tablet of placebo self-inserted by the patient 12 hours before IUD insertion. |
|
| 10 minutes |