Role of Local Skin Incision Infiltration by Oxytocin On Wound Healing of Caesarean Section Scar in Primiparous Women A Double Blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Wound healing after Oxytocin injecton
研究概览
简要总结
caesarean section rate in Egypt has reached about 60% between primgravidae.
Wound complications are of the most common morbidities following cesarean section. The prevalence of wound infection and disruption after cesarean has been reported as 3-15%, averagely speaking 6% and 2-42% in various studies.
These complications affect mother's quality of life due to stress, anxiety, delay in mother's ability and health recovery
详细描述
Nowadays, cesarean is one of the most common surgical interventions and its prevalence has increased in most countries in the recent years.
At present, all efforts are focused on the early and effective healing of caesarean skin wound and its associated complications.
There is a wide range of topical and systemic treatments for the management of caesarean skin incision. Topical treatments have side effects and hence are not considered as the treatment of choice for such incisions.
Oxytocin is a Nonapeptide hormone of a cyclic six amino-acid structure and a tail of three amino acids, responsible for initiation of the milk ejection reflex and stimulating the uterine contractions.
However, other important roles of oxytocin include improvement of social life, exerting pain-relieving, anti anti-stress/anti-inflammatory and restorative effects, friendship and making social relationship with individual or group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primigravidae women,
- •Age group from 20- 35 years old.
- •Gestational age 37-41 weeks, and
- •Elective caesarean section due to obstetrics indication.
- •The patient signed an Informed Consent Form authorizing their inclusion
排除标准
- •Multiparous women,
- •Assisted vaginal delivery,
- •Normal vaginal delivery,
- •Emergency caesarean section,
- •Preterm pre labour rupture of membrane,
- •Primiparous women with age above 35 years old,
- •Primiparous women with known connective tissue disease and
- •Women suffering from chronic diseases such as diabetes, hypertension, cardiovascular diseases, psychiatric diseases, cancer
- •Smoking Women
研究组 & 干预措施
Group A
About 50 Patients Will receive 20 units of local oxytocin infiltration before skin closure . 10 units of oxytocin will be infiltrated at the upper skin edge and 10 units of oxytocin will be infilterated at the lower skin edges at equal intervals of 2 cm in between infiltration points.
干预措施: Oxytocin (Drug)
Group B
About 50 Patients Will receive the 10 units of local oxytocin infiltration before skin closure . 5 units will be infiltrated at the upper skin edge and 5 units will be infiltrated at the lower skin edge at equal intervals of approximately 2 cm in between infiltration points.
干预措施: Oxytocin (Drug)
结局指标
主要结局
Wound healing after Oxytocin injecton
时间窗: from baseline to 6 days after the Cesarean operation
Injection of the Oxytocin hormon in the cesarean wound before closing it during cesarean delivery and close watching for healing process.
Pain Relief
时间窗: From base line to 6 hours postoperatively
The effect of oxytocin on pain relief using pain score scale, numerical pain score scale from 0-10 where 0 is no pain, from 1-3 is mild pain,4-6 moderate pain and from 7-10 is severe pain.
次要结局
未报告次要终点