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

Phase 2

Completed

• Conditions: Cesarean Section; Dehiscence; Cesarean Scar Niche
• Interventions: Drug: alpha lipoic acid drug (thioctic acid acid); Drug: Placebo Oral Tablet

• Registration Number: NCT03257514
• Lead Sponsor: Ain Shams University

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-07-30
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-22
• Primary Completion: 2018-01-01
• Study Completion: 2018-02-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 102

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
alpha lipoic acid	alpha lipoic acid drug (thioctic acid acid)	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 Oral Tablet	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)

Primary Outcome Measures

Name	Time	Method
presence of scar niche	six weeks after CS	triangular shaped anechoic area at the site of incision
The healing ratio	six weeks after CS	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

Trial Locations

Locations (1)

Ain Shams University Maternity Hospital; 🇪🇬 Cairo, Abbassia, Egypt