Effect of Alpha Lipoic Acid on Uterine Scar Healing After Cesarean Section

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Assessing The Effect of Alpha Lipoic Acid on Uterine Scar Healing After Cesarean Section by Using Saline Contrast Sonohysterography

Conditions
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Cesarean Section; Dehiscence, Cesarean Scar Niche

Intervention / Treatment
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* Drug: alpha lipoic acid drug (thioctic acid acid)
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Term pregnancy (gestational age between 37-41 weeks). Women undergoing cesarean section for the first time. Normal vaginal ultrasound examination and exclusion of any pelvic abnormality. Uncomplicated cesarean section. Lower uterine segment cesarean sections while the women not in labor. Exclusion Criteria: Women with complications during or after cesarean section as intrapartum or postpartum hemorrhage, puerperal sepsis, septic wound Women with medical diseases that can affect the healing as diabetes mellitus, anemia, chronic renal disease or hepatic disease or coagulopathy or receiving medications affect wound healing as corticosteroids or anticoagulant. Women who will use intrauterine device as a contraceptive method Women with uterine abnormality as cervical stenosis or fibroid uterus Women with pelvic infection at the time of saline sonohysterography

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: alpha lipoic acid<br>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)<br>* Alpha lipoic acid has anti-inflammatory, antioxidant effects and plays a role in wound healing process.<br>|
| Placebo Comparator: placebo<br>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<br>* placebo oral drug have the same shape of thiotacid tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |