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

Cesarean Section; Dehiscence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03257514
• Other study ID #: maternity hospital ASU
• Status: Completed
• Phase: Phase 2
• First received: July 30, 2017
• Last updated: March 6, 2018
• Start date: June 1, 2017
• Est. completion date: February 1, 2018

Study information

• Verified date: March 2018
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: February 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Scar Niche
• Cesarean Section; Dehiscence

Intervention

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 Oral Tablet
placebo oral drug have the same shape of thiotacid tablet

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo	Abbassia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	presence of scar niche	triangular shaped anechoic area at the site of incision	six weeks after CS
Primary	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