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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02318420 |
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Date of registration:
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04/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The PartoMa Project: For Improving Monitoring, Action and Triage During Labour
PartoMa |
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Scientific title:
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The PartoMa Project for Saving Lives at Birth - An Intervention Based Study to Strengthen the Quality of Monitoring, Action and Triage During Labour at an East African Referral Hospital |
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Date of first enrolment:
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October 1, 2014 |
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Target sample size:
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3087 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02318420 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Tanzania
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Contacts
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Name:
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Ib C Bygbjerg, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Copenhagen |
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Name:
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Nanna Maaløe, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Copenhagen |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- All women in labour delivering at the study site and their outcome, October 2014 -
January 2015 and October 2015 - January 2016
- All health care providers at the department during the baseline and intervention
period, October 2014 - January 2016
For the different substudies, sub-groups are selected (please see the secondary outcomes
for a description).
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Maternal Death
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Obstetric Labor Complications
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Stillbirth
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Intervention(s)
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Other: The PartoMa intervention
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Primary Outcome(s)
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Composite outcome of stillbirths and birth asphyxia
[Time Frame: A comparison of the baseline (Oct. 14 - Jan. '15) with 9th-12th month of the intervention (Oct. '15 - Jan. '16).]
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Secondary Outcome(s)
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Cesarean sections and vacuum extractions
[Time Frame: A comparison of the baseline (Oct. 14 - Jan. '15) with 9th-12th month of the intervention (Oct. '15 - Jan. '16).]
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Process indicators of quality of intrapartum labour care
[Time Frame: A comparison of the baseline (Oct. 14 - Jan. '15) with 9th-12th month of the intervention (Oct. '15 - Jan. '16).]
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Maternal death
[Time Frame: A comparison of the baseline (Oct. 14 - Jan. '15) with 9th-12th month of the intervention (Oct. '15 - Jan. '16).]
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HALE
[Time Frame: This will be evaluated economically after finalizing the study period.]
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Health providers' perception of their work situation in the labour and delivery rooms
[Time Frame: This is assessed at multiple time points throughout the study period and more in-depth after 2 years of the intervention.]
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The women's experience of care received during delivery.
[Time Frame: This is assessed through community visits in January - March 2016.]
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Secondary ID(s)
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R164-2013-16038
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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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