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To compare the effect of vaginal dinoprostone versus vaginal misoprostol administered before the copper intrauterine device(IUD) insertion in reducing IUD insertion pain and the difficulty in inserting the IUD in multiparous overweight and obese 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 |
|---|---|---|---|
| dinoprostone | Experimental | 2 vaginal tablet of dinoprostone (3mg) (prostinĀ® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion. |
|
| misoprostol | Active Comparator | 2 vaginal tablet of misoprostol (200 mcg) (MisotacĀ®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion. |
|
| placebo | Placebo Comparator | Placebo Comparator: placebo 2 tablet of placebo inserted by the study nurse 3 hours before IUD insertion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dinoprostol | Drug | 2 vaginal tablet of dinoprostone (3mg) (prostinĀ® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference in visual analog scale pain scores during intrauterine device insertion | The difference in pain scores during intrauterine device insertion using visual analog scale from 0 to 10 | 10 minuts |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of pain: visual analogue scale | Pain intensity will be assessed by visual analogue scale 30 minutes after the procedure.visual analogue scale ranging from 0 to 10 | 30 minutes after the procedure |
| the difference in visual analog scale pain scores during tenaculum application |
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Inclusion Criteria:
Exclusion Criteria:
multipara overweight and obese women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hany f Sallam, md | Contact | +20102435461 | 002 | hany.farouk@aswu.edu.eg |
| nahla w Shady, md | Contact | +201022336052 | hanygyne@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| nahla w Shady, md | Aswan universirty | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University Hospital | AswÄn | 81528 | Egypt |
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| ID | Term |
|---|---|
| C501608 | KLK15 protein, human |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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double blind randomized controlled trial
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double blind randomized controlled trial
|
| misoprostol | Drug | 2 vaginal tablet of misoprostol (200 mcg) (MisotacĀ®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion. |
|
|
| placebo | Drug | 2 tablet of placebo inserted by the study nurse 3 hours before IUD insertion |
|
|
The difference in pain scores during tenaculum application using a visual analog scale from 0 to 10 |
| 10 minutes |
| the ease of IUD insertion | the ease of IUD insertion using ease of insertion score from 0 to 10 cm (0 = very easy insertion, 10 cm = terribly difficult insertion) | 10 minutes |
| women's satisfaction level: score | women's satisfaction level using satisfaction score from 0 to 10 cm where 0 denotes no satisfaction and 10 denotes maximum satisfaction | 10 minutes |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |