Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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5 December 2016 |
Main ID: |
NCT02223806 |
Date of registration:
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11/08/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Active Management of the Third Stage of Labour: Uterine Tonus Assessment by Midwife vs. Patient Self-administration
UTAMP |
Scientific title:
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Active Management of the Third Stage of Labour: Uterine Tonus Assessment by Midwife vs. Patient Self-administration |
Date of first enrolment:
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April 2014 |
Target sample size:
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800 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02223806 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Ghana
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Contacts
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Name:
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Kerstin D Klipstein-Grobusch, PhD MSc |
Address:
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Telephone:
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Email:
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Affiliation:
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University Medical Center Utrecht, The Netherlands |
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Name:
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Nelson Damale, MBChB |
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Telephone:
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Email:
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Affiliation:
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Korle-Bu Teaching Hospital, Accra, Ghana |
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Name:
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Joyce L Browne, MD, MSc |
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Telephone:
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Email:
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Affiliation:
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UMC Utrecht, the Netherlands |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Postpartum Hemorrhage
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Intervention(s)
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Behavioral: Patient self-assessment of uterine tonus
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Behavioral: Uterine Tonus Assessment by Midwife
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Primary Outcome(s)
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Postpartum hemorrhage (>500 ml blood loss)
[Time Frame: within 24 hours postpartum]
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Secondary Outcome(s)
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Severe post-partum hemorrhage
[Time Frame: Within 24 hours postpartum]
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Use of additional uterotonics
[Time Frame: Within 24 hours postpartum]
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Late postpartum hemorrhage
[Time Frame: From 24 hours and upto one week]
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Mean blood loss (in ml)
[Time Frame: Within 24 hours postpartum]
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Use of other procedures for management of postpartum hemorrhage
[Time Frame: Within 24 hours postpartum]
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Secondary ID(s)
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UMC-GH 002
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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