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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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PACTR |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
PACTR201602001301205 |
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Date of registration:
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11/10/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The lift-less intervention to prevent preterm birth and low birthweight - a stepped wedge cluster randomized controlled trial.
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Scientific title:
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Lift-Less Intervention to prevent preterm birth and low birthweight among Ghanaian pregnant women- a study protocol of a stepped-wedge cluster randomised controlled. |
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Date of first enrolment:
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01/06/2018 |
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Target sample size:
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1000 |
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Recruitment status: |
Suspended |
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URL:
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https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1301 |
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Study type:
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Interventional |
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Study design:
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Crossover: all participants receive all interventions in different sequence during study,Randomised,Allocation will be done by the use of a computer-generated number sequence,The allocation will be done by a professional who will not be part of the delivery of the treatment or its assessment
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Phase:
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Not Applicable
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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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Emma
Kwegyir-Afful |
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Address:
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Erämiehenpolku 8 as 23
65370
Vaasa
Finland |
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Telephone:
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0404495521 |
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Email:
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emmakwe@uef.fi |
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Affiliation:
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Doctoral Student |
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Name:
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Emma
Kwegyir-Afful |
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Address:
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Erämiehenpolku 8 as 23
65370
Vaasa
Finland |
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Telephone:
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+358404495521 |
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Email:
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emmakwe@uef.fi |
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Affiliation:
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Doctoral Student |
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Key inclusion & exclusion criteria
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Inclusion criteria: Pregnancy has been confirmed by ultrasound, abdominal examination or both.
Pregnancy is singleton.
The pregnant woman should attend one of the selected 10 antenatal clinics
The participant is exposed to lifting of 10 kg once every 5 minutes for industrial workers (and on average of 5-6 times per hour based on local conditions).Necessary adjustment will be made to this criterion.
The pregnant woman has consented to participate in the trial.
Exclusion criteria: Women with multiple (eg.twin) pregnancies.
Women with complicated (eg.eclampsia) pregnancies.
Age minimum:
16 Year(s)
Age maximum:
50 Year(s)
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Prematurity and low birthweight
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Prematurity and low birthweight
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Intervention(s)
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The lift-less intervention
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Routine antenatal care
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Primary Outcome(s)
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Gestational age
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Secondary Outcome(s)
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Birthweight
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Mode of delivery
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Premature uterine contractions
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Back pains / pelvic pain
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Secondary ID(s)
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GHS-ERC:20/11/15
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STATEMENT 13/2015
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Source(s) of Monetary Support
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None
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Ethics review
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Status: Approved
Approval date:
Contact:
Ghana Health Service Ethics Review Committee
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Status: Approved
Approval date: 14/09/2015
Contact:
University of Eastern Finland Committee on Research Ethics
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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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