A Novel Technique Of Uterine Cooling During Repeated Cesarean Section For Reducing Blood Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Post-operative Vaginal Blood Loss (ml)
研究概览
简要总结
Study aim to evaluate the efficacy and safety of a novel technique of UTERINE COOLING during repeated cesarean section (CS) in reducing blood loss, and record any adverse effects following it.
详细描述
Bleeding during vaginal or operative delivery is always of prime concern. Despite significant progress in obstetric care 125,000 women die from obstetric hemorrhage annually in the world.
The incidence of caesarean delivery is increasing, and the average blood loss during caesarean delivery (1000 mL) is double the amount lost during vaginal delivery (500 mL).
Caesarean section (CS) rate as high as 25-30% in many areas of the world. In Egypt the CS rate is 27.6 %, in United States of America, from 1970-2009 the CS rate rose from 4.5-32.9%, and declined to 32.8% of all deliveries at 2010. In spite of the various measures to prevent blood loss during and after caesarean section, post-partum hemorrhage (PPH) continues to be the most common complication seen in almost 20% of the cases, and causes approximately 25% of maternal deaths worldwide, leading to increased maternal morbidity and mortality. Indeed we need to reduce the bleeding during and after caesarean sections aiming for reducing the morbidity and mortality rate due to obstetric hemorrhage, which can be life threatening.
The hematocrit level falls by 10% and blood transfusion is required in 6% of women undergoing caesarean delivery versus 4% of women who have a vaginal birth. Numerous methods for performing caesarean section exist targeting a safe delivery for the infant with minimum maternal morbidity. Operative morbidity includes hemorrhage, anemia, and blood products transfusion may be required associated with many risks and complications.
Women who undergo a caesarean delivery are much more likely to be delivered by a repeat operation in subsequent pregnancies. For women undergoing subsequent cesarean, the maternal risks are even greater like massive obstetric hemorrhage, hysterectomy, admission to an intensive care unit, or maternal death. Medications, such as oxytocin, misoprostol and prostaglandin F2α, have been used to control bleeding postoperatively.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy at term between 38±5 days and 40 weeks.
- •Elective planned or emergency repeated lower segment cesarean sections(LSCS).
- •Pregnant women who will accept to be in the study, and have giveninformed consent.
排除标准
- •Women who refuse to be in the study, and women who are unable to consentdue to emergent nature of the cesarean section will be excluded. Women whoare unable to understand the nature of the study due to mental illness, mentalretardation, medical condition, or other communication barrier will be excluded,or who with severe medical and surgical complications as any of the followingwill be excluded :
- •Heart, liver, kidney, or brain diseases, and blood disorders.
- •Abruptio placenta, and placental abnormalities or accrete syndromes.
- •Polyhydraminos, macrosomia, or preeclampsia.
- •History of thromboembolic disorders, or severe anemia.
结局指标
主要结局
Post-operative Vaginal Blood Loss (ml)
时间窗: 6 hours
Estimating Vaginal Blood Loss (ml) during 6 hours post LSCS.
Intra-operative Blood Loss (ml)
时间窗: 20 minutes
Estimating Blood Loss during LSCS immediately after delivery of the fetus and prior to delivery of the placenta till closure of uterine incision.
次要结局
- Use of any additional measures to control blood Loss, including any pharmacological or surgical interventions.(7 hours)
- Patient temperature pre, intra, and postoperative.(7 hours)
- Change in Pre- versus Post-operative Hematocrit value.(48 hours post operative period)
- Use of Methergine.(6 hours)
- Total time uterus wrapped during hysterotomy repair.(30 minutes)
- Change in Pre- versus Post-operative Hemoglobin value.(48 hours post operative period)
- Use of extra Oxytocin (more than 5 i.u.).(20 minutes)
- Requirement of blood products.(6 hours)
- Total blood loss greater than 1000 cc.(7 hours)
- Uterine temperature after wrap removal.(Less than one minute)
- Use of Misopristole.(6 hours)
研究者
Amro M. Hetta
Doctoral Degree (MD) Candidate
Al-Azhar University