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

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 Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Behavioral: Patient self-assessment of uterine tonus; Behavioral: Uterine Tonus Assessment by Midwife

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.

• Study Type: Interventional
• Enrollment (Actual): 800
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ghana
  • Accra, Ghana
    • Korle Bu Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Collaborators: University of Ghana; Korle-Bu Teaching Hospital, Accra, Ghana
• Investigators: Principal Investigator: Joyce L Browne, MD, MSc, UMC Utrecht, The Netherlands; Principal Investigator: Kerstin D Klipstein-Grobusch, PhD MSc, University Medical Center Utrecht, the Netherlands; Principal Investigator: Nelson Damale, MBChB, Korle-Bu Teaching Hospital, Accra, Ghana

Publications and helpful links

General Publications

• Browne JL, Damale NK, Raams TM, Van der Linden EL, Maya ET, Doe R, Rijken MJ, Adanu R, Grobbee DE, Franx A, Klipstein-Grobusch K. Uterine Tonus Assessment by Midwives versus Patient self-assessment in the active management of the third stage of labor (UTAMP): study protocol for a randomized controlled trial. Trials. 2015 Dec 18;16:580. doi: 10.1186/s13063-015-1111-5.

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: August 11, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 22, 2014

Study Record Updates

• Last Update Posted (Estimate): November 25, 2016
• Last Update Submitted That Met QC Criteria: November 23, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Postpartum hemorrhage; Uterine tonus assessment; Active management of third stage of labor
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: UMC-GH 002