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To investigate whether vaginal isonicotinic acid hydrazide administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in in Women Delivered Only by Cesarean Delivery.
Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device is attempted through a narrow cervical canal. intrauterine device insertion- related complications and side effects are more common among women who had never delivered vaginally.
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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 vaginal tablet of Placebo Comparator self-inserted 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 12 hours before IUD insertion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the difference in the pain intensity scores between the study groups | the difference in the pain intensity scores between the study groups at IUD insertion BY10 cm visual analog scale score where 0 denotes no pain and 10 denotes the most imaginable pain | 10 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 minutes |
| insertion time |
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Inclusion Criteria:
Exclusion Criteria:
Women Delivered Only by Elective 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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| ID | Term |
|---|---|
| D007538 | Isoniazid |
| ID | Term |
|---|---|
| D006834 | Hydrazines |
| D009930 | Organic Chemicals |
| D007539 | Isonicotinic Acids |
| D000147 | Acids, Heterocyclic |
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double blind randomized trial
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double blind randomized trial
| Placebo Comparator | Drug | 3 vaginal tablet of Placebo Comparator self inserted 12 hours before IUD insertion |
|
IUD insertion time from speculum in to speculum out
| 10 minutes |
| D006571 |
| Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |