Active Management of the Third Stage of Labour: Uterine Tonus Assessment by Midwife vs. Patient Self-administration

Study Overview
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Brief Summary
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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
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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.

Official Title
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Active Management of the Third Stage of Labour: Uterine Tonus Assessment by Midwife vs. Patient Self-administration

Conditions
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Postpartum Hemorrhage

Intervention / Treatment
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* Behavioral: Uterine Tonus Assessment by Midwife
* Behavioral: Patient self-assessment of uterine tonus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Age <18 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Self-assessment of uterine tonus<br>Uterine tonus assessment every 15 minutes for 2 hours by educated patient, which is standard-of-care. | Behavioral: Patient self-assessment of uterine tonus<br>* Uterine tonus assessment by patient every 15 minutes for 2 hours.<br>|
| Experimental: Midwife uterine tonus assessment<br>Uterine tonus assessment every 15 minutes for 2 hours by midwive. | Behavioral: Uterine Tonus Assessment by Midwife<br>* Uterine tonus assessment every 15 minutes for 2 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postpartum hemorrhage (>500 ml blood loss) | 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. | within 24 hours postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean blood loss (in ml) |  | Within 24 hours postpartum | 
| Severe post-partum hemorrhage | >1000ml blood loss | Within 24 hours postpartum | 
| Use of additional uterotonics |  | Within 24 hours postpartum | 
| Use of other procedures for management of postpartum hemorrhage | I.e. surgery, manual placenta tissue removal | Within 24 hours postpartum | 
| Late postpartum hemorrhage | Based on readmission | From 24 hours and upto one week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum hemorrhage, Uterine tonus assessment, Active management of third stage of labor