Efficacy of calcium gluconate in prevention of uterine atony during lower segmental cesarean section delivery: A randomized controlled trial
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- The primary outcome variable of the study is the incidence of uterine atony and hence PPH in cesarean section (PPH is defined by a blood loss more than 1000ml, need for a second line uterotonic or any additional mechanical/surgical measures by surgeon to stop bleeding like bimanual compression, uterine packing, balloon tamponade, B lynch sutures, Cho sutures, Hayman sutures, uterine artery ligation or embolization or hysterectomy).
研究概览
简要总结
Postpartum hemorrhage (PPH) is one of the most common causes of maternal mortality worldwide including India. Uterine atony accounts for 90% of cases of postpartum hemorrhage. Postpartum hemorrhage is a dreaded third stage complication arising most commonly from uterine atony but less frequently from coagulopathy, genital tract trauma or retained placental tissues. Prevention of PPH includes general measures like correction of pre-existing anemia, routine use of partogram which helps to avoid prolonged labour, active management of third stage of labour (AMTSL), routine inspection for retained products of placenta or any genital tract trauma, prophylactic oxytocin bolus or infusion before delivery of placenta to promote uterine contractions and to improve tone. Management of PPH is by medical, mechanical and surgical methods. Medical management includes resuscitation with intravenous fluids blood and blood products and use of uterotonic (oxytocin, carboprost, methylergometrine, misoprostol). Mechanical methods include uterine massage, manual compression of uterus, intrauterine tamponade (Bakri balloon, condom catheter). Surgical measures include application of sutures in uterus (B-Lynch, Hayman sutures), uterine artery ligation and emergency hysterectomy. Routinely oxytocin is used as a prophylaxis and second line uterotonics (Carboprost, Methylergometrine, Misoprostol) are used as treatment for PPH. But second line uterotonics have significant limitation in form of cost and other associated medical conditions limiting their use. So, there is a need to search second line drugs which can be used as a preventive or treatment modality for PPH. Calcium plays an important role in uterine contractility in physiological conditions. A number of in vitro studies have established that myometrial contractility is dependent upon extracellular calcium levels. In the setting of low or absent extracellular calcium, amplitude of myometrial contraction diminishes and oxytocin’s efficacy in inducing myometrial contraction diminishes by 60-75%. Low serum concentration of calcium affects normal uterine contractility during normal labor and PPH. Jessica R et al, in a pilot study demonstrated that one gram of calcium chloride is significantly effective in prevention of uterine atony without any significant adverse effects of hypercalcemia. So, we hypothesize that supraphysiologic effect of calcium by administration of calcium gluconate in equivalent dose of one gram of calcium chloride is effective in prevention of uterine atony in Indian population and hence will reduce incidence of postpartum haemorrhage and need for blood transfusion without any adverse effect of significant hypercalcemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Pregnant female patients (18 to 45 years of age) 2)ASA physical class II or III 3)Emergency or elective LSCS with risk factors of PPH 4)Patients who have atleast two of the following established risk factors for uterine atony: intrapartum Cesarean delivery, failed operative vaginal delivery with forceps or vacuum, magnesium infusion, Chorioamnionitis, multiple gestation, Polyhydramnios, preterm delivery <37 weeks, prior history of postpartum hemorrhage, labor induction or augmentation with oxytocin, advanced maternal age, obesity with body mass index >40.
排除标准
- •Patient refusal to participate in the study 2)Maternal history of cardiac disease, arrhythmias, CAD 3)History of renal dysfunction with serum creatinine>1.0 mg/dL 4)Patients with placenta accreta 5)Treatment with digoxin within the last 2 weeks for a maternal or fetal indication 6)Treatment with a calcium channel blocker within 24 hours 7)General anaesthesia.
结局指标
主要结局
The primary outcome variable of the study is the incidence of uterine atony and hence PPH in cesarean section (PPH is defined by a blood loss more than 1000ml, need for a second line uterotonic or any additional mechanical/surgical measures by surgeon to stop bleeding like bimanual compression, uterine packing, balloon tamponade, B lynch sutures, Cho sutures, Hayman sutures, uterine artery ligation or embolization or hysterectomy).
时间窗: 0 to 24 hours
次要结局
- The study intends to compare the amount of intraoperative blood loss, requirement of intravenous fluids and blood products if PPH occur in a case. The study also aims to compare intraoperative hemodynamic parameters between the two groups. Total units of oxytocin boluses and other uterotonics used in 24 hours will also be recorded. Uterine tone will be assessed by numerical rating score(0-100) at 3, 6, and 10 minutes after fetal delivery and the absolute 10 minute score as well as relative from 10-3 and 10-6 minute scores will also be analysed.(0 to 24 hours)