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Completed

NCT Number: NCT03257514

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

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

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ain Shams University Maternity Hospital

Cairo, Abbassia, 02002, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

alpha lipoic acid drug (thioctic acid acid)

Drug

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

Placebo oral tablet

Drug

placebo oral drug have the same shape of thiotacid tablet

Primary outcomes

  1. presence of scar niche

    Time frame: six weeks after CS

    triangular shaped anechoic area at the site of incision

  2. The healing ratio

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 22, 2017
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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