Intraumbilical Vein Injection of Oxytocin in Routine Practice for Active Management of the Third Stage of Labor
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 412
- 主要终点
- the amount of blood loss in third and fourth stages of labor
研究概览
简要总结
During the first hours that follow the birth of the baby (third and fourth stages of labor), complications are common and can threaten the mother's life. The most common complication is postpartum hemorrhage (PPH), which remains a leading cause of maternal mortality (25.0%) especially in developing countries .Three to five percent of deliveries are complicated by PPH and is 50 times more common in developing countries. Retained placenta is an another complication of third stage of labor. It complicates 0.1-2 % of deliveries . Without prompt treatment, women are at high risk of hemorrhage. At present, treatment is by manual removal of placenta, which needs an operating theatre, a surgeon, and an anaesthetist-facilities that are often unavailable to women in resource-poor settings. As a result, this condition has a case fatality rate of nearly 10% in rural communities.
The length of the third stage of labor, and its subsequent complications depends on a combination of the length of time it takes for placental separation and the ability of the uterine muscle to contract. Principal management of the third stage of labor is aimed at reducing the time of delivery of placenta so minimising serious adverse effects, such as blood loss and retained placenta. Active management of the third stage of labor, which includes prophylactic injection of 10 units of oxytocin within two minutes of birth, early clamping of the umbilical cord and controlled cord traction (CCT), is recommended by WHO for PPH prevention .
Umbilical vein oxytocin injection directs the treatment to the placental bed and uterine wall, resulting in an earlier uterine contraction and placental separation. However, very limited published literature is available, which evaluated the effect of umbilical vein oxytocin injection in routine practices for active management of the third stage of labor. The purpose of this investigation was to find out the beneficial effect of adding intraumbilical vein oxytocin in reducing the blood loss during third and fourth stages of labor, length of third stage of labor, and reduction in the incidence of manual removal of retained placenta.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 35 Years（Child, 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
- •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
Saline group
Only 30 mL of saline was injected directly in the umbilical vein after clamping. The injection was performed with a 30-mL syringe and an 18-gauge needle around 1 to 2 cm from the introitus. The solution was injected slowly over 1 minute and at the end of the injection, the solution was milked toward the cord insertion.
干预措施: Oxytocin (Drug)
结局指标
主要结局
the amount of blood loss in third and fourth stages of labor
时间窗: The end of the delivery to 2 hours after birth.
次要结局
- duration of the third stage