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To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications, and pain in multiparous women.
Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device (IUD) is attempted through a narrow cervical canal.IUD insertion- related complications and side effects are more common among women who had never delivered vaginally. Pain can be perceived during all steps of IUD insertion including the application of the tenaculum to the cervical lip, sounding the uterus and advancing the IUD introducer through the cervical canal inside the uterine cavity
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dinoprostone | Experimental | 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) self-inserted by the patients 3 hours before the scheduled IUD insertion appointment. |
|
| placebo | Placebo Comparator | one tablet of placebo self-inserted by the patients 3 hours before the scheduled IUD insertion appointment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dinoprostone | Drug | 1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) self-inserted by participants 3 hours before scheduled IUD insertion appointment. |
| 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 by visual analog scale score which ranges from zero to 10.where zero represents no pain and 10 represents the most worst pain | 5 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AHMED SAMY | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of medicine Cairo university | Giza | 11231 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32732105 | Derived | Ashour AS, Nabil H, Yosif MF, Hussein M, Mageed A Allah AA, Mahmoud M, Abdou H, Kholaif K, Mohamed Kotb MM, El Sharkawy M, Abdelhakim AM, Ali AS, Nassar SA, Abbassy AH, Ghamry NK, Abdel-Latif AA, Taher A, El Mahy M. Effect of self-administered vaginal dinoprostone on pain perception during copper intrauterine device insertion in parous women: a randomized controlled trial. Fertil Steril. 2020 Oct;114(4):861-868. doi: 10.1016/j.fertnstert.2020.05.004. Epub 2020 Jul 28. |
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| ID | Term |
|---|---|
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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| placebo | Drug | one tablet of placebo self-inserted by participants 3 hours before scheduled IUD insertion appointment. |
|
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |