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

NCT ID: NCT02223806

Last Updated: 2016-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-08-31

Brief 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.

Conditions

Postpartum Hemorrhage

Keywords

Postpartum hemorrhage; Uterine tonus assessment; Active management of third stage of labor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Self-assessment of uterine tonus

Uterine tonus assessment every 15 minutes for 2 hours by educated patient, which is standard-of-care.

Group Type: ACTIVE_COMPARATOR

Patient self-assessment of uterine tonus

Intervention Type: BEHAVIORAL

Uterine tonus assessment by patient every 15 minutes for 2 hours.

Midwife uterine tonus assessment

Uterine tonus assessment every 15 minutes for 2 hours by midwive.

Group Type: EXPERIMENTAL

Uterine Tonus Assessment by Midwife

Intervention Type: BEHAVIORAL

Uterine tonus assessment every 15 minutes for 2 hours.

Interventions

Uterine Tonus Assessment by Midwife

Uterine tonus assessment every 15 minutes for 2 hours.

Intervention Type: BEHAVIORAL

Patient self-assessment of uterine tonus

Uterine tonus assessment by patient every 15 minutes for 2 hours.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Korle-Bu Teaching Hospital, Accra, Ghana

OTHER

Sponsor Role: collaborator

University of Ghana

OTHER

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: lead

Responsible Party

Joyce L. Browne

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joyce L Browne, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht, the Netherlands

Kerstin D Klipstein-Grobusch, PhD MSc

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Utrecht, The Netherlands

Nelson Damale, MBChB

Role: PRINCIPAL_INVESTIGATOR

Korle-Bu Teaching Hospital, Accra, Ghana

Locations

Korle Bu Teaching Hospital

Accra, , Ghana

Countries

Ghana

References

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.

Reference Type: DERIVED

PMID: 26683621 (View on PubMed)

Other Identifiers

UMC-GH 002

Identifier Type: -

Identifier Source: org_study_id