Efficacy and safety of IV Tranexamic acid in the prevention of postpartum haemorrhage:A Randomized controlled study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- Calculated EBL(cEBL)-Estimated blood vol×(predelivery or preop haematocrit− Post delivery or postop haematocrit)/predelivery or preop haematocrit. Estimated blood vol in ml -bodyweight in kg×85. For participants who received transfusion before postnatal blood sample taken,the corrected postop hb will be post-transfusion hb 48 hrs postop− (1 × unit of RBC transfused), and postop haematocrit as post-transfusion haematocrit 48 hrs postop − (3 × units of RBC transfused).
研究概览
简要总结
All women undergoing vaginal delivery/LSCS admitted in Dept of Obstetrics and Gynaecology,KGMU fulfilling the inclusion criteria will be enrolled after written informed consent.
Information on age, education, parity, occupation, income and obstetric history will be obtained from the woman using a questionnaire.
Using a computer generated randomisation sequence, eligible pregnant women in the study will be randomly divided into two equal groups of 240 (240 in each group)
Participants haemoglobin & haematocrit levels will determined within the week before delivery
Group 1- Receiving IV Tranexamic acid (1 gm )
Group 2- Control group ( Not receiving IV tranexamic acid )
Women undergoing vaginal delivery –
Women will receive IV tranexamic acid slowly during 30-60 sec during crowning of the fetal head .After vaginal delivery active management of third stage of labor will be done as per the standard protocol using 10 IU oxytocin IM and controlled cord traction.
Women undergoing caesarean section-
In caesarean births, the IV tranexamic acid slowly during 30-60 sec will be given prior to skin incision, immediately after draping
This will be followed by active management of third stage of labor will be done as per the standard protocol using 10 IU oxytocin IM and controlled cord traction.
Delivered women will be followed for any amount of blood loss .The amount of blood loss after vaginal delivery will be estimated using Caliberated drapes placed under the buttocks after delivery and using pictorial charts .
During LSCS blood loss will be estimated using Gravimetrical estimation method assessed by weighing the swabs and drapes as well as measuring the volume of suction aspirated once the amniotic fluid volume had been deducted or provider estimated blood loss by the surgical team whichever is feasible.
Those women who will develop atonic PPH ( defined as blood loss >500 ml after vaginal delivery or >1000 ml after LSCS or any blood loss sufficient to compromise haemodynamic stability within 24 h of birth will be managed as per protocol.
Pulse and BP will be recorded at intervals of 15 minutes.
The uterine tone and amount of bleeding will be assessed and need for further uterotonics will be determined.
Need for blood or other blood products transfusion.
Participants haemoglobin & haematocrit levels will be repeated around 24 hours post-delivery.
The total amount of blood loss will then be objectively calculated using blood volume and haematocrit of the woman using the formula
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.All women undergoing vaginal delivery/LSCS at QMH,KGMU.
- •2.Patient who have given written informed consent will be taken.
排除标准
- •1.Patient not giving written informed consent 2.Antenatal diagnosis of placenta accreta spectrum (PAS), 3.Genital tract trauma 4.Known background of thrombophilia or coagulopathy 5.Women with renal, cardiac or liver disease.
- •6.Known hypersensitivity with tranexamic acid.
- •7.Women with increased risk of arterial or venous thrombosis 8.Women with epilepsy or seizures.
结局指标
主要结局
Calculated EBL(cEBL)-Estimated blood vol×(predelivery or preop haematocrit− Post delivery or postop haematocrit)/predelivery or preop haematocrit. Estimated blood vol in ml -bodyweight in kg×85. For participants who received transfusion before postnatal blood sample taken,the corrected postop hb will be post-transfusion hb 48 hrs postop− (1 × unit of RBC transfused), and postop haematocrit as post-transfusion haematocrit 48 hrs postop − (3 × units of RBC transfused).
时间窗: 48 hours
次要结局
- 1.Need for additional medical interventions (additional uterotonics, additional TXA(2.Need for additional surgical & mechanical interventions for haemostasis)
研究者
Aradhya Garg
King George Medical University,Lucknow,Uttar Pradesh