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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19 December 2023 |
Main ID: |
NCT02239341 |
Date of registration:
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08/09/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.
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Scientific title:
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Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women. |
Date of first enrolment:
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October 30, 2014 |
Target sample size:
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9 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/ct2/show/NCT02239341 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Michelle F Mottola, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of Western Ontario, Canada |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Hospitalized high-risk pregnant women in hospital for at least 7 days
- Diagnosed with gestational hypertension
- Diagnosed with preeclampsia (mild to moderate)
- Diagnosed with intrauterine growth restriction
- Single baby
- Expecting twins
- Expecting triplets
- Diagnosed with shortened cervix
- Diagnosed with threatened pre-term labour (not actively contracting)
Exclusion Criteria:
- Diagnosed with symptomatic placenta previa (bleeding)
- Diagnosed with severe pre-eclampsia (immediate delivery)
- Diagnosed with conditions indicating a short term hospital stays of less than 7 days
- Diagnosed with infections
- Diagnosed with heart and renal disease
- Diagnosed with diabetes
- Diagnosed with metabolic bone disease
- Diagnosed with hyper-or-hypo-thyroidism
- Diagnosed with Cushing disease and anemia
- Women carrying more than 3 babies
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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High-Risk Pregnancy
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Intervention(s)
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Other: Muscle Conditioning Intervention
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Other: Music Intervention
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Primary Outcome(s)
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Score on the Functional Mobility Assessment Tool
[Time Frame: 2 weeks post delivery]
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Secondary Outcome(s)
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Quality of life
[Time Frame: Baseline (> 28 weeks gestation); 2 weeks post delivery; 2, 6 and 12 months post delivery]
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Follow up to Primary outcome Score for Functional Mobility Assessment Tool
[Time Frame: 2, 6 and 12 months]
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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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