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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: |
NCT03062228 |
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Date of registration:
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19/02/2017 |
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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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KBTH-GIRHL Healthy Birth Weight Study: A Cross-Section
KBTH-HBWS |
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Scientific title:
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Korle Bu Teaching Hospital - Global Innovations for Reproductive Health & Life Healthy Birth Weight Study: A Cross-Section |
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Date of first enrolment:
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April 28, 2016 |
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Target sample size:
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162 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03062228 |
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Study type:
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Observational |
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Study design:
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Phase:
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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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Maxfield Okere, B.Sc. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Korle Bu Teaching Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Low-risk singleton pregnancy
- *Delivered a live birth >28 weeks gestation at KBTH within the past 48 hours.
- Residing in the Greater Accra Metropolitan Area or area served by the KBTH.
- Fluent in either English, Twi, or Ga
- **Has not received education/ information about back sleep position in pregnancy as a
potential risk factor for stillbirth and low birth weight.
Exclusion Criteria:
- BMI = 35 at booking (first antenatal appointment for current pregnancy)
- Pregnancy complicated by obstetric complications (hypertension [pre-eclampsia,
gestational hypertension, chronic hypertension], diabetes [gestational or not], or
intra-uterine growth restriction [<10th %ile for growth])
- Sleep complicated by medical conditions (known to get <4 hours of sleep per night due
to insomnia, or musculoskeletal disorder that prevents sleeping on a certain side
[e.g., arthritic shoulder])
- Multiple pregnancy
- Known fetal abnormality
- Maternal age >35
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Sleep
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Infant, Small for Gestational Age
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Infant, Low Birth Weight
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Infant, Very Low Birth Weight
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Fetal Growth Retardation
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Pregnancy
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Primary Outcome(s)
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Customized Birth Weight Centile
[Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)]
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Birth Weight of Baby
[Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)]
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Secondary Outcome(s)
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Low Birth Weight
[Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)]
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Gestational Age at Delivery
[Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)]
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Sex of Newborn
[Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)]
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Mode of Delivery
[Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)]
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Preterm Delivery
[Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)]
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Small for Gestational Age
[Time Frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)]
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Secondary ID(s)
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KBTH-IRB/00020/2016
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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