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This is a prospective randomized controlled study to determine the effect of prostaglandin intake before Mirena IUD insertion It was conducted at the Department of Obstetrics & Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University,
The study aiming to measure the estimate difficulty of insertion of the Mirena IUD by using prostaglandins 2 hours before the procedure and the effect of prostaglandins to make this procedure easy with other side effects and complications as bleeding perforation, nausea, vomiting, failure of insertion and comparing them with a placebo group who didn't receive prostaglandins
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| prostaglandins before iud insertion group | this group will receive 200 mcg prostaglandins in form of misoprostol 2 hrs before mirena iud insertion |
| |
| placebo group | this group will receive placebo tablet before mirena iud insertion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | misoprostol 200 mcg will be given sublingual 2 hrs before mirena iud insertion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difficulty of insertion of Mirena IUD by using the Ease of Insertion score graduated as VAS like scale | By using the visual analogue score | During the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| cervical dilataion < 4 mm | need for cervical dilatation to pass the IUD | During the intervention |
| Pain at insertion according to VAS | By using the visual analogue score |
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Inclusion Criteria:
Exclusion Criteria:
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female patients during the lactational amenorrhea who undergo Mirena IUD insertion after had been delivered by CS within 6 monthes
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hany saad, assisstant prof | Contact | 01001817211 | hanysaad25280@gmail.com | |
| hadeer meshaal, assistant prof | Contact | 01001435238 | dr_hadeer@live.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Recruiting | Cairo | 02 | Egypt |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| During the intervention |
| Subjective sensation of satisfaction graduated as VAS like scale | By using the visual analogue score like system | During the intervention |
| side effects during IUD insertion: bleeding, vasovagal reaction, cramps, nausea, perforation, vomiting | Bleeding by using the soaked bads | During the intervention |
| side effects after 24 hrs of IUD insertion: nausea, vomiting, cramps and hyperthermia | During the first 24 hours |
| side effects after 30 days of IUD insertion: spotting, cramps, acute PID and expulsion | After 30 days of intervention |
| Duration of insertion(min) | From start of procedure till removing the speculum | During the intervention |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |