Efficacy of Different Uterine Compression Sutures in Controlling Excessive Uterine Bleeding During Caesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- need for hysterctomy
研究概览
简要总结
The investigators found that B- Lynch suture is more effective than Nausicca suture in controlling excessive uterine bleeding during cesarean section and avoiding the need of hysterectomy.
Also, the investigators found that B- lynch suture needs shorter procedure time with less blood loss compared to Nausicca suture.
Consequently the investigators recommend the use of B-Lynch suture as a compressive uterine suture to control excessive uterine bleeding during cesarean section and avoid the need of hysterectomy.
As a result of this study the investigators recommend further studies to compare different uterine compressive suture to verify the most effective uterine compressive suture.
详细描述
The objective of this study is to compare the efficacy of Nausicaa suture and B -lynch suture in controlling excessive uterine bleeding during cesarean section and avoiding the need for hystserctomy.
The investigators established this randomized controlled trial on participants with excessive uterine bleeding during cesarean section not responding to uterine massage and ecbolics in obstetric operative theatre in Ain Shams Maternity Hospitals.
During cesarean section, sixty participants who suffered from excessive uterine bleeding during cesarean section and not responding to uterine massage and ecbolics and who are willing to participate in the study and gave informed consent had Nausicaa or B-Lynch uterine compressive suture after randomizations using opaque sealed envelopes.
The selection of the type of suture done after allocation of women into two groups as llows:
Group (A):
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 (Outcomes Assessor)
盲法说明
Double blinding is difficult because the observer will see the type of procedure done. However, the measured outcomes are objective and unlikely to be biased by lack of blinding.
入排标准
- 年龄范围
- 16 Years 至 42 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients delivering by cesarean section with postpartum haemorrhage(intended for conservative management) as in
- •Non morbidly adherent placenta praevia.
- •Cases of uterine atony as in (Failed tocolysis, Twins, Polyhydramnios and History of postpartum haemorrhage).
- •After failed conservative management of excessive uterine massage and ecbolics
排除标准
- •1- Severely haemodynamic instablility needing immediate hysterectomy. 2- Morbidly adherent placenta: accrete, increta or percreta. 3- Patients with coagulopathy:
- •Receiving anticoagulant therapy.
- •With thrombocytopenia or thrombasthenia.
- •known coagulation factor defect. 4 -Distorted uterus as unicornuate, bicornuate, fibroid uterus and adenomyosis uteri.
结局指标
主要结局
need for hysterctomy
时间窗: within 24 hours
need for hysterctomy to control bleeding in cesarean section(YES/NO)
次要结局
- blood loss(within 6 hours)
- peripartum heamoglobin drop(within 6 hours)
- procedure time(1 hour)
- need for devascularisation(1 hour)
- ICU admission(24 hours)
- Venous thromboembolism(6 weeks)
- postoperative fever(48 hours)
研究者
Amany Salah El Din Abd El Hafeez Abd El Hady,MSC
MD Student
Ain Shams Maternity Hospital