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

NCT03257514 | Completed Phase 2

• 1 other identifier: maternity hospital ASU
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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

Conditions

Cesarean Section; Dehiscence; Cesarean Scar Niche

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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)

Drug: alpha lipoic acid drug (thioctic acid acid)

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)

Drug: Placebo Oral Tablet

Interventions

alpha lipoic acid drug (thioctic acid acid) DRUG

Alpha lipoic acid has anti-inflammatory, antioxidant effects and plays a role in wound healing process.

alpha lipoic acid

Placebo Oral Tablet DRUG

placebo oral drug have the same shape of thiotacid tablet

placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Term pregnancy (gestational age between 37-41 weeks).
• Women undergoing cesarean section for the first time.
• Uncomplicated cesarean section.
• Lower uterine segment cesarean sections while the women not in labor.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Abbassia, 02002, Egypt

Location

MeSH Terms

Interventions

Thioctic Acid

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: July 30, 2017
• First Posted: August 22, 2017
• Study Start: June 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 8, 2018

Record last verified: 2018-03

Locations

EG (1)