Topical Tranexamic Acid Plus Bilateral Uterine Artery Ligation During Hemorrhagic Cesarean Delivery for Complete Placenta Previa: a Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants with postpartum hemorrhage
研究概览
简要总结
Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 200 live births. It is considered one of the causes of the increased need for blood transfusion and cesarean hysterectomy. PPH due to PP typically starts during cesarean section (CS) in the placental bed, at the lower uterine segment mostly after placental separation. Proceeding for cesarean hysterectomy can be the only effective line of management in spite of the associated high morbidity rate.
Various conservative measures have been developed to avoid hysterectomy and preserve fertility in patients with PP. Bilateral Uterine artery ligation (BUAL) is one of the reported surgical procedures carried out in these cases as it is easy and quick. It can be used alone or with adjunctive measures with a fair success rate. The aim is to reduce the blood supply to the uterus and to prevent postpartum hemorrhage.
Tranexamic acid is a lysine analog which acts as an antifibrinolytic via competitive inhibition of the binding of plasmin and plasminogen to fibrin. The rationale for its use in the reduction of blood loss depending on the implication of the coagulation and fibrinolysis processes implicated in the control of PPH. However, concerns about possible thromboembolic events with parenteral administration of TA have stimulated increasing interest in its topical use.
详细描述
Study inclusion criteria will be women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures Eligible participants were allocated to one of two groups. Group (I): patients managed by bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures. Group (II): patients received 1 gm TA (2 ampoules of Capron® 500 mg /5 ml; Cairo, Egypt) topically applied to the placental bed plus BUA when not respond to uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which was used
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
排除标准
- •patients with the high possibility of morbid adherent placenta
- •those presented with severe antepartum hemorrhage
- •Patients with cardiac, hepatic, renal, or thromboembolic disease;
- •hypersensitivity or contraindications of use of tranexamic acid
- •patient refuses to consent
研究组 & 干预措施
BUAL plus placebo
bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures plus 200 ml saline topical application to placental bed
干预措施: BUA (Procedure)
BUAL plus placebo
bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures plus 200 ml saline topical application to placental bed
干预措施: placebo (Drug)
BUAL plus topical tranexamic acid
bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures plus topical application of 20ml saline contains 2 gm tranexamic acid
干预措施: BUA (Procedure)
BUAL plus topical tranexamic acid
bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures plus topical application of 20ml saline contains 2 gm tranexamic acid
干预措施: topical tranexamic acid (Drug)
结局指标
主要结局
Number of Participants with postpartum hemorrhage
时间窗: 6 hours post operative
number pf participants with blood loss \> 1000ml
次要结局
- The number of participant needed for blood transfusion(24 hours post operative)
- The number of participant needed of extra surgical maneuvers(24 hours post operative)
- intraoperative blood loss(during the operation)
研究者
hany farouk
Principal Investigator
Aswan University Hospital
