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To investigate whether vaginal isonicotinic acid hydrazide (INH) administered before the levonorgestrel-releasing intrauterine system(IUs) insertion reduces failed insertions, insertion-related complications, and pain in Women With no Previous Vaginal Delivery.
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 (900mg) ( inserted by the study nurse 4 hours before IUD insertion. |
|
| Placebo Comparator | Placebo Comparator | one tablet of placebo inserted by the study nurse 4 hours before IUD insertion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INH | Drug | 3 vaginal tablet of isonicotinic acid hydrazide (900mg) inserted by the study nurse 4 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 |
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Inclusion Criteria:
Exclusion Criteria:
Non-pregnant women who delivered only by cesarean section
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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 trial
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double blind randomized controlled trial
| Placebo Comparator | Drug | 3 tablet of placebo inserted by the study nurse 4 hours before IUD insertion. |
|