Assessing The Effect of Alpha Lipoic Acid on Uterine Scar Healing After Cesarean Section by Using Saline Contrast Sonohysterography
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- presence of scar niche
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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)
干预措施: alpha lipoic acid drug (thioctic acid acid) (Drug)
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)
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
presence of scar niche
时间窗: six weeks after CS
triangular shaped anechoic area at the site of incision
The healing ratio
时间窗: 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
次要结局
未报告次要终点
研究者
Radwa Rasheedy Ali
lecturer
Ain Shams University