Active Management of the Third Stage of Labour: Uterine Tonus Assessment by Midwife vs. Patient Self-administration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Postpartum hemorrhage (>500 ml blood loss)
研究概览
简要总结
To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) when performed by a midwife or self-administered by a patient on the incidence of postpartum haemorrhage, mean blood loss, and other maternal and neonatal outcomes.
详细描述
Rationale: Postpartum haemorrhage (PPH) is the most common cause of maternal death worldwide. The active management of the third stage of labour (AMTSL) is recognized as an effective strategy to prevent morbidity and mortality associated with PPH and reduce blood loss. AMTSL includes the provision of uterotonic drugs, controlled cord traction, delayed cord clamping and cutting, massage of the uterus, and monitoring of the uterine tonus. Although professional guidelines recommend the steps of AMTSL to be performed by health professionals, the reality of health professionals understaffed hospitals in many low- and middle income countries (LMICs) necessitates task-shifting of the final AMTSL component to patients. Yet, whether uterine tonus assessment yields the same effect when performed by patients and midwives has not been formally evaluated.
Objective
To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) when performed by a midwife or self-administered by a patient on the incidence of postpartum haemorrhage . mean blood loss, and other maternal and neonatal outcomes.
Study design: Randomized intervention study. Study population: Pregnant women admitted in the labour to the Korle Bu Teaching Hospital, Accra, Ghana Intervention: the intervention group will receive uterine tonus assessment every 15 minutes for 2 hours by a midwife, the control group will continue the current practice of self-assessment after patient education with regular monitoring of midwives.
Main study parameters/endpoints: post-partum haemorrhage (>500 ml blood loss), severe postpartum haemorrhage (>1000 ml blood loss), mean blood loss, other maternal and neonatal outcomes.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will receive the standard of midwifery and obstetric care, and will have access to emergency obstetric interventions. All steps of the AMTSL will be performed, with the exemption of the last step of uterine tonus assessment for which women will be randomized to receive the intervention or current practice of care. Risk associated with the intervention are discomfort because of an external assessment. Data will be obtained from record books at the ward. Women will be asked for informed consent prior to participation. This study will be approved by the Ethical en Protocol Review Committee of the University of Ghana Medical School and the Medical Ethical Research Committee of the University Medical Center Utrecht.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Be in labor with an expected vaginal delivery, as assessed by the midwives
- •Gestation age ≥ 37 weeks
- •Received antenatal instructions on postnatal uterine tonus assessment
- •Provided informed consent.
排除标准
- •Elective caesarean delivery
- •Severe anemia (<8g/dL)
- •Placenta praevia
- •Anticipated breech delivery
- •Referred patients who have not received antenatal care (ANC) uterine tonus assessment instructions
- •Multiple Pregnancy
- •Intra uterine fetal death
研究组 & 干预措施
Self-assessment of uterine tonus
Uterine tonus assessment every 15 minutes for 2 hours by educated patient, which is standard-of-care.
干预措施: Patient self-assessment of uterine tonus (Behavioral)
Midwife uterine tonus assessment
Uterine tonus assessment every 15 minutes for 2 hours by midwive.
干预措施: Uterine Tonus Assessment by Midwife (Behavioral)
结局指标
主要结局
Postpartum hemorrhage (>500 ml blood loss)
时间窗: within 24 hours postpartum
To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) to prevent post-partum hemorrhage (≥500 ml blood loss) when performed by a midwife and self-administered by a patient.
次要结局
- Mean blood loss (in ml)(Within 24 hours postpartum)
- Use of other procedures for management of postpartum hemorrhage(Within 24 hours postpartum)
- Severe post-partum hemorrhage(Within 24 hours postpartum)
- Use of additional uterotonics(Within 24 hours postpartum)
- Late postpartum hemorrhage(From 24 hours and upto one week)