A Phase 2 interventional study of alpha lipoic acid drug (thioctic acid acid) and Placebo Oral Tablet in Cesarean Section; Dehiscence and Cesarean Scar Niche, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2018-03-08.
Sponsored by Ain Shams University · Phase 2, Interventional, and Prevention
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.
Exclusion Criteria:
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)
Drug: alpha lipoic acid drug (thioctic acid acid)
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)
Drug: Placebo Oral Tablet
Alpha lipoic acid has anti-inflammatory, antioxidant effects and plays a role in wound healing process.
placebo oral drug have the same shape of thiotacid tablet
presence of scar niche
triangular shaped anechoic area at the site of incision
Time frame: 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
Time frame: six weeks after CS
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Ain Shams University