Phase 3 Study of Postpartum Oxygen Inhalation for the Treatment of Postpartum Haemorrhage
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- The primary outcome was the amount of blood loss in the third and fourth stages of labor.
研究概览
简要总结
In the aetiology of postpartum uterine atony, hypoxia is considered an important factor although some suggest that peripheral oxygen saturation is not influenced by oxygen inhalation in women during the first and second stages of labor. Enhancing oxygen delivery to myometrium through additional inhaled oxygen may improve uterine contractions. Therefore, it is reasonable to consider that oxygen inhalation may promote myometrial contraction and prevent postpartum haemorrhage (PPH) due to uterine atony. The tendency for the uterus to relax in women encountering respiratory problems immediately after cesarean section under general anaesthesia further strengthened this theory.
The aim of this study was to evaluate the effectiveness of oxygen inhalation immediately after vaginal delivery on blood loss. The investigators hypothesized that inhaled oxygen helps to maintain uterine retraction during immediate postpartum period and hence reduces vaginal blood loss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •gestational age between 37 and 42 weeks;
- •singleton pregnancy;
- •live fetus;
- •cephalic presentation;
- •neonatal birth weight of 2500-4500 g;
- •parity between one and five;
- •maternal age < 35 years old;
- •vaginal birth
排除标准
- •blood pressure ≥ 140/90mmHg;
- •placenta previa;
- •placental abruption;
- •a history of any bleeding during pregnancy;
- •a history of curettage;
- •cesarean section or any uterine scar;
- •a history of postpartum hemorrhage;
- •polyhydramnios;
- •signs or symptoms of maternal infection;
- •known uterine anomalies;
- •history of any drug use during labor;
- •abnormal placentation;
- •coagulation defects;
- •instrumental deliveries;
- •hemoglobin concentration < 8 g/dL;
- •history of anticoagulant drugs;
- •beta-mimetic medications during pregnancy;
- •prolongation of the first stage of labor > 15 hours
研究组 & 干预措施
oxygen
干预措施: oxygen (Drug)
结局指标
主要结局
The primary outcome was the amount of blood loss in the third and fourth stages of labor.
时间窗: two hours
The volume of blood loss was measured by weighing a sheet soaked from the end of the delivery to 2h after birth. Because it is important to collect the blood accurately, we used a specially designed operating sheet and an electronic scale to weigh all the material (with a 1 g deviation range). The quantity of blood (ml) = (weight of used materials - weight of materials prior to use)/1.05. Hemoglobin concentration was estimated on admission and 24 h after delivery
次要结局
- incidences of Postpartum Haemorrhage (PPH) (≥500 ml)(two hours)