Cesarean Scar Niche, Cesarean Section; Dehiscence
Conditions
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
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.
Interventions
Alpha lipoic acid has anti-inflammatory, antioxidant effects and plays a role in wound healing process.
DRUGPlacebo Oral Tablet
placebo oral drug have the same shape of thiotacid tablet
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| presence of scar niche | six weeks after CS | triangular shaped anechoic area at the site of incision |
| The healing ratio | 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 |
Countries
Egypt
Outcome results
None listed