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investigators aim through this study to evaluate and compare the Safety and efficacy of different doses of misoprostol prior to IUCD insertion among women with nulliparous cervix beside the rate of occurrence of adverse effects.
Today there is an ever-increasing variety of effective contraceptive methods. Although all have side effects, they offer a lower risk than that conferred by pregnancy Contraceptive methods are classified according to their effectiveness. The top tier offer the highest level of effectiveness (defined as \
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1- Group 1 (misoprostol 200 mcg | Active Comparator | Group 1 :will take 1 tablet (200 mcg) of misoprostol and 1 placebo tablet, ., |
|
| 2- Group 2 (misoprostol 100 mcg) | Active Comparator | Group 2: will take1 tablet (100 mcg) of misoprostol and 1 placebo tablet, |
|
| 3- Group 3 (placebo group) | Placebo Comparator | Group 3 ): will take2 placebo tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | Tablets will be inserted digitally by an experienced gynecologist 3hours before IUD insertion with taking care not inserting the medication into the cervix. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores | Pain scores will be measured using a visual analogue scale (VAS) consisting of a 10 cm horizontal straight line on which 0 cm corresponded to no pain and 10 cm to the worst pain. The pain score will be measured within 5 min of insertion of the IUD tube. | during insertion of IUCD |
| Measure | Description | Time Frame |
|---|---|---|
| The ease of IUD insertion | The ease of IUD insertion: using the ease of insertion score (ES): a graduated VAS-like scale from 0 to 10; in which 10 means terribly difficult insertion and 0 means very easy insertion. The ES was validated for use in previous similar studies about IUD insertion (Abbas et al., 2017). | during insertion ofIUCD |
| Measure | Description | Time Frame |
|---|---|---|
| The side effects of the study medication | as shivering, nausea, vomiting and diarrhea | within 3 hours from inserting the misoprostol tablet |
| Complications from IUD insertion | as abdominal cramps, uterine bleeding, perforation and cervical trauma |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed h Salama, MD.MRCOG | Ainshams uinversity | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Maternity Hospital | Cairo | Egypt | ||||
| Misr University for Science & Technology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27823944 | Background | Abbas AM, Abdellah MS, Khalaf M, Bahloul M, Abdellah NH, Ali MK, Abdelmagied AM. Effect of cervical lidocaine-prilocaine cream on pain perception during copper T380A intrauterine device insertion among parous women: A randomized double-blind controlled trial. Contraception. 2017 Mar;95(3):251-256. doi: 10.1016/j.contraception.2016.10.011. Epub 2016 Nov 4. | |
| 28088498 |
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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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|
| Successful IUD insertion |
Successful IUD insertion which will be assessed by vaginal US device 'Samsung h 60' through the following criteria:
|
| 5minutes after insertion of IUCD |
| The duration of insertion in seconds | The duration of insertion in seconds: starting from putting loaded applicator at the external os till withdrawal of the applicator after IUD insertion | during insertion ofIUCD |
| The women's level of satisfaction at the end of insertion | The women's level of satisfaction at the end of insertion: every woman will express her level of satisfaction with IUD insertion by completing a 10-cm VAS (with 0 = no satisfaction and 10 = maximum satisfaction). | 1 miute after insertion of IUCD |
| during insertion ofIUCD |
| The number of women who need additional analgesics after the insertion | 5 minutes after insertion |
| Failure of IUD insertion, due to technical difficulty or intolerance of the patient | during IUCD insertion |
| Cairo |
| Egypt |
| Abdellah MS, Abbas AM, Hegazy AM, El-Nashar IM. Vaginal misoprostol prior to intrauterine device insertion in women delivered only by elective cesarean section: a randomized double-blind clinical trial. Contraception. 2017 Jun;95(6):538-543. doi: 10.1016/j.contraception.2017.01.003. Epub 2017 Jan 11. |
| 17488782 | Background | Aronsson A, Fiala C, Stephansson O, Granath F, Watzer B, Schweer H, Gemzell-Danielsson K. Pharmacokinetic profiles up to 12 h after administration of vaginal, sublingual and slow-release oral misoprostol. Hum Reprod. 2007 Jul;22(7):1912-8. doi: 10.1093/humrep/dem098. Epub 2007 May 8. |
| 26040478 | Background | Bahamondes MV, Espejo-Arce X, Bahamondes L. Effect of vaginal administration of misoprostol before intrauterine contraceptive insertion following previous insertion failure: a double blind RCT. Hum Reprod. 2015 Aug;30(8):1861-6. doi: 10.1093/humrep/dev137. Epub 2015 Jun 3. |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |