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The aim of the work is to evaluate the efficacy of the sub lingual prostaglandin E1 synthetic analogue (misoprostol) before IUD insertion to facilitate the procedure in patients delivered before only by cesarean section.
The study will be conducted at Ain Shams University Maternity Hospital. 124 women candidate for Cu T 380A IUD insertion will be enrolled in the study. Half of them will receive 400 micro gram of misoprostol (Sigma) sub lingually and the other half will receive the placebo two hours before IUD insertion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol | Experimental | Women will receive two sub lingual tablets each containing 200 micro gram misoprostol (Misotac), receiving a total dose of 400 micro grams. Two hour later, Cu T 380A IUD (PREGNA) will be inserted. |
|
| Placebo | Placebo Comparator | Women will receive two sub lingual placebo tablets which will be similar in size, color, odor and shape to the misoprostol tablets. Two hour later, Cu T 380A IUD (PREGNA) will be inserted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain | The perception of pain and discomfort as described by the patient assessed by Visual Analogue Scale (VAS). The scale will be graded from 0 to 10, 0 representing no pain at all and 10 worst possible imaginable pain. | During the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Difficulty of Procedure | The degree of difficulty of the IUD insertion judged by the investigator as the resistance met at the internal cervical os. The procedure either graded as (easy), (moderate difficulty) or (difficult) or (failed insertion). | During the procedure |
| Complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed S. Sweed, MD | Ain Shams University | Principal Investigator |
| Hassan A. Bayoumy, Professor | Ain Shams University | Study Director |
| Mohamed Y. Mohamed, M.B., B.Ch. | Assiut University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Maternity Hospital | Cairo | 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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| Placebo | Drug |
|
Uterine perforation, excessive bleeding, fever, IUD expulsion or any other unexpected complications will be assessed during the procedure and followed for the next 24 hours. |
| During the procedure and the following 24 hours. |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |