Effectiveness and Safety Dosing of Sodium Bicarbonate in Women With Obstructed Labor in Eastern Uganda: A Phase III Randomized Placebo-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 472
- 试验地点
- 1
- 主要终点
- Mean change in maternal pH from baseline in each group
研究概览
简要总结
The goal of this clinical trial is to determine a universal safe and effective dose of sodium bicarbonate for use among women with Obstructed labour to treat acidosis. It will also learn about the safety of sodium bicarbonate drug among women with Obstructed labour.
Researchers will compare sodium bicarbonate drug to normal saline (a look-alike solution) to see if sodium bicarbonate works to treat acidosis.
Participants will receive sodium bicarbonate solution or a placebo up to two doses, four hours apart.
详细描述
Oral bicarbonate is a safe, cheap and effective acid buffer, widely used in sports to improve performance because of its ability to prevent and reverse the effects of metabolic acidosis. Clinically, it is used in intensive care units to treat patients with overwhelming infections or poisoning. In low resource settings, obstructed labor (OL) is a major problem that accounts for 22% of maternal deaths. The fetal harm of OL comes from intrapartum asphyxia, characterized by accumulation of hydrogen ions that cross the placental barrier to cause fetal acidosis. Acidosis causes failure of basic cellular functions resulting into cell death. In a recent Randomised Clinical Trial, the investigators found that 61% of 477 women with OL were acidotic (lactate >4.8 mmol/L), with a median capillary blood lactate level of 6.9 (3.4-13) mmol/L.
The investigators propose an early phase III, placebo-controlled dose-ranging trial to determine the efficacy and safety of a pre-operative infusion of sodium bicarbonate in women with obstructed labour (OL). In a ratio of 1:1:1: 1 100 mls (8.4g), 150 mls (12.6g) and 200 mls (16.8g) of 8.4% sodium bicarbonate solution, or placebo (50 mls of Normal Saline 0.9%). The primary outcome will be mean change in acidosis (pH and lactate levels) from baseline. The secondary outcomes will be neonatal death, safety of sodium bicarbonate, pharmacokinetics of sodium bicarbonate in pregnant women, primary postpartum haemorrhage, sepsis, and maternal death.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with obstructed labour
- •Must be a singleton pregnancy
- •Must be a term pregnancy (≥37 weeks of gestation)
- •Must be in cephalic presentation.
排除标准
- •Patients with other obstetric emergencies such as antepartum haemorrhage, preeclampsia and eclampsia (defined as elevated blood pressure of at least 140/90 mm Hg, urine protein of at least 2+, any of the danger signs and fits), premature rupture of membranes and intrauterine fetal death.
- •Patients with comorbidities such as diabetes mellitus, sickle cell disease, renal disease, liver disease and heart disease.
- •Patients with hypokalaemia (148 mmol/L) and alkalosis (bicarbonate >22 mmol/L) because they are more likely to develop adverse drug reactions
研究组 & 干预措施
8.4g of 8.4% sodium bicarbonate solution Arm
Each participant will receive 100mls of 8.4g, 8.4% sodium bicarbonate solution, up to two doses, four hours apart.
干预措施: 8.4% sodium bicarbonate solution (Drug)
12.6g of 8.4% sodium bicarbonate solution Arm
Each participant will receive 150mls of 12.6g, 8.4% sodium bicarbonate solution, up to two doses, four hours apart.
干预措施: 8.4% sodium bicarbonate solution (Drug)
16.8g of 8.4% sodium bicarbonate solution Arm
Each participant will receive 200mls of 16.8g, 8.4% sodium bicarbonate solution, up to two doses, four hours apart.
干预措施: 8.4% sodium bicarbonate solution (Drug)
Normal Saline 0.9% Arm
Each participant will receive 50mls of Normal Saline 0.9%, up to two doses, four hours apart.
干预措施: 0.9% Normal Saline (Other)
结局指标
主要结局
Mean change in maternal pH from baseline in each group
时间窗: At baseline, 30, 60, 90, 120 and 150 minutes
Mean umbilical blood pH in each arm of the study
时间窗: At baseline, 30, 60, 90, 120 and 150 minutes
次要结局
- Mean lactate in maternal and umbilical blood,(At baseline and at birth.)
- Number of early neonatal deaths(Within 7 days)
- Number of mothers that get primary postpartum hemorrhage(Within 24 after birth)
- Safety of sodium bicarbonate (comparison of the proportion of participants that get side effects in each arm)(Within 24 hours after administration of the drug)