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

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

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Dehiscence; Cesarean Scar Niche
• Intervention / Treatment: Drug: alpha lipoic acid drug (thioctic acid acid); Drug: Placebo Oral Tablet

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 Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Abbassia
    • Cairo, Abbassia, Egypt, 02002
      • Ain shams university maternity hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: July 30, 2017
• First Submitted That Met QC Criteria: August 18, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): March 8, 2018
• Last Update Submitted That Met QC Criteria: March 6, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin B Complex; Thioctic Acid
• Other Study ID Numbers: maternity hospital ASU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No