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The aim of this study is to evaluate the efficacy of alpha lipoic acid on uterine scar healing after cesarean section by using saline contrast sonohysterography
This is a triple blind randomized placebo controlled prospective clinical trial that will be conducted in Ain Shams University Maternity Hospital.
in which a consecutive series of participant attending emergency room 102 women undergoing cesarean section for the first time will be randomized into two groups.
Group A (Study group): 51 women will receive alpha lipoic acid drug ( 600 mg twice daily) for 6 weeks after cesarean section and saline sonohysterography will be done after that.
Group B (Control group): 51 women will receive a placebo drug twice daily for 6 weeks after cesarean section and saline sonohysterography will be done after that.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alpha lipoic acid | Active Comparator | 51 women will receive alpha lipoic acid drug (thiotacid film coated tablets 600 mg) for 6 weeks after cesarean section then uterine scar healing will be assessed by saline sonohysterography (by placing catheter in the cervical os helping to administering saline into uterine cavity then using the transvaginal ultrasound to view the uterus in the longitudinal view) |
|
| placebo | Placebo Comparator | 51 women will receive a placebo drug for 6 weeks after cesarean section then uterine scar healing will be assessed by saline sonohysterography(by placing catheter in the cervical os helping to administering saline into uterine cavity then using the transvaginal ultrasound to view the uterus in the longitudinal view) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alpha lipoic acid drug (thioctic acid acid) | Drug | Alpha lipoic acid has anti-inflammatory, antioxidant effects and plays a role in wound healing process. |
|
| Measure | Description | Time Frame |
|---|---|---|
| presence of scar niche | triangular shaped anechoic area at the site of incision | six weeks after CS |
| The healing ratio | the thickness of residual myometrium covering the defect divided by the sum of the thickness of residual myometrium cover the defect and the height of wedge shaped defect | six weeks after CS |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Maternity Hospital | Cairo | Abbassia | 02002 | Egypt |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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| Placebo Oral Tablet | Drug | placebo oral drug have the same shape of thiotacid tablet |
|
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |