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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: ClinicalTrials.gov
Last refreshed on: 19 December 2023
Main ID:  NCT02239341
Date of registration: 08/09/2014
Prospective Registration: Yes
Primary sponsor: Western University, Canada
Public title: Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.
Scientific title: Effects of Two In-hospital Antepartum Interventions on Functional Ability and Quality of Life in Early Postpartum Women.
Date of first enrolment: October 30, 2014
Target sample size: 9
Recruitment status: Completed
URL:  https://clinicaltrials.gov/ct2/show/NCT02239341
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).  
Phase:  N/A
Countries of recruitment
Canada
Contacts
Name:     Michelle F Mottola, PhD
Address: 
Telephone:
Email:
Affiliation:  University of Western Ontario, Canada
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
High-Risk Pregnancy
Intervention(s)
Other: Muscle Conditioning Intervention
Other: Music Intervention
Primary Outcome(s)
Score on the Functional Mobility Assessment Tool [Time Frame: 2 weeks post delivery]
Secondary Outcome(s)
Quality of life [Time Frame: Baseline (> 28 weeks gestation); 2 weeks post delivery; 2, 6 and 12 months post delivery]
Follow up to Primary outcome Score for Functional Mobility Assessment Tool [Time Frame: 2, 6 and 12 months]
Secondary ID(s)
105699
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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