NCT02223806

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 11, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

November 25, 2016

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

August 11, 2014

Last Update Submit

November 23, 2016

Conditions

Postpartum Hemorrhage

Keywords

Postpartum hemorrhageUterine tonus assessmentActive management of third stage of labor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Mean blood loss (in ml)

    Within 24 hours postpartum

  • Severe post-partum hemorrhage

    Within 24 hours postpartum

  • Use of additional uterotonics

    Within 24 hours postpartum

  • Use of other procedures for management of postpartum hemorrhage

    Within 24 hours postpartum

  • Late postpartum hemorrhage

    From 24 hours and upto one week

Study Arms (2)

Self-assessment of uterine tonus

ACTIVE COMPARATOR

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

Behavioral: Patient self-assessment of uterine tonus

Midwife uterine tonus assessment

EXPERIMENTAL

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

Behavioral: Uterine Tonus Assessment by Midwife

Interventions

Uterine Tonus Assessment by MidwifeBEHAVIORAL

Uterine tonus assessment every 15 minutes for 2 hours.

Midwife uterine tonus assessment
Patient self-assessment of uterine tonusBEHAVIORAL

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

Self-assessment of uterine tonus

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Korle Bu Teaching Hospital

Accra, Ghana

Location

Related Publications (1)

  • 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.

    PMID: 26683621DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

August 11, 2014

First Posted

August 22, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

November 25, 2016

Record last verified: 2016-11

Locations

GH(1)