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

Postpartum Hemorrhage Clinical Trial

— UTAMP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02223806
• Other study ID #: UMC-GH 002
• Status: Completed
• Phase: N/A
• First received: August 11, 2014
• Last updated: November 23, 2016
• Start date: April 2014
• Est. completion date: August 2015

Study information

• Verified date: November 2016
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ghana: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Behavioral:
• Uterine Tonus Assessment by Midwife
Uterine tonus assessment every 15 minutes for 2 hours.
• Patient self-assessment of uterine tonus
Uterine tonus assessment by patient every 15 minutes for 2 hours.

Locations

Country	Name	City	State
Ghana	Korle Bu Teaching Hospital	Accra

Sponsors (3)

Lead Sponsor	Collaborator
UMC Utrecht	Korle-Bu Teaching Hospital, Accra, Ghana, University of Ghana

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Mean blood loss (in ml)		Within 24 hours postpartum	No
Secondary	Severe post-partum hemorrhage	>1000ml blood loss	Within 24 hours postpartum	No
Secondary	Use of additional uterotonics		Within 24 hours postpartum	No
Secondary	Use of other procedures for management of postpartum hemorrhage	I.e. surgery, manual placenta tissue removal	Within 24 hours postpartum	No
Secondary	Late postpartum hemorrhage	Based on readmission	From 24 hours and upto one week	No