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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-02-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cesarean Section; Dehiscence Cesarean Scar Niche

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

alpha lipoic acid drug (thioctic acid acid)

Intervention Type DRUG

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

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)

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

placebo oral drug have the same shape of thiotacid tablet

Interventions

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alpha lipoic acid drug (thioctic acid acid)

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

Intervention Type DRUG

Placebo Oral Tablet

placebo oral drug have the same shape of thiotacid tablet

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No