Active Management of the Third Stage of Labour: Uterine Tonus Assessment by Midwife vs. Patient Self-administration
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Uterine Tonus Assessment by Midwife; Patient self-assessment of uterine tonus
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Uterine tonus assessment every 15 minutes for 2 hours.; Uterine tonus assessment by patient every 15 minutes for 2 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Postpartum hemorrhage; Uterine tonus assessment; Active management of third stage of labor