Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201602001301205 Date of Approval: 11/10/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The lift-less intervention to prevent preterm birth and low birthweight - a stepped wedge cluster randomized controlled trial.
Official scientific title Lift-Less Intervention to prevent preterm birth and low birthweight among Ghanaian pregnant women- a study protocol of a stepped-wedge cluster randomised controlled.
Brief summary describing the background and objectives of the trial Prematurity and low birthweight are leading causes of death in children under the age of five. Both conditions are common in low and middle-income countries where women carry out strenuous physical activities for daily living. Globally, for preterm birth, Ghana was ranked 14th out of 184 countries in the world in 2010. In about 40 to 50% preterm births, the causes are unknown. Although there have been several attempts by various institutions and countries to provide occupational guidelines to protect pregnant employees, such guidelines do not exist in developing countries like Ghana. However, as gold standard, no randomized trial have been done to investigate the usefulness or otherwise of such clinical guidelines to prevent preterm birth and low birthweight. We intend to carry out a stepped-wedge randomized controlled trial with a 3-component intervention comprising; health education based on clinical guidelines, a take-home reminder card and a social support in the form of a shopping voucher. The ultimate aim of the trial is to decrease preterm birth among pregnant Ghanaian women by reducing their heavy lifting and carrying tendencies. The impact of the lift-less intervention to decrease physical stress and the resultant incidence of low birthweight and preterm birth among participants will be assessed and compared with no such intervention.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TLLI
Disease(s) or condition(s) being studied Prematurity and low birthweight
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/06/2018
Actual trial start date 01/08/2016
Anticipated date of last follow up 30/09/2016
Actual Last follow-up date 31/12/2019
Anticipated target sample size (number of participants) 1000
Actual target sample size (number of participants) 1000
Recruitment status Suspended
Publication URL https://academic.oup.com/occmed/advance-article-abstract/doi/10.1093/occmed/kqx166/4641817?redirectedFrom=fulltext
Secondary Ids Issuing authority/Trial register
GHS-ERC:20/11/15 Ghana Health Service Ethics Review Committee
STATEMENT 13/2015 University of Eastern Finland Committee on Research Ethics
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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 Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group The lift-less intervention 5 study sessions with 6 shopping vouchers Throughout the pregnancy 3-component lift-less intervention. 500
Control Group Routine antenatal care Throughout the pregnancy Throughout the pregnancy Routine antenal care 500 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. Women with multiple (eg.twin) pregnancies. Women with complicated (eg.eclampsia) pregnancies. 16 Year(s) 50 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/09/2015 University of Eastern Finland Committee on Research Ethics
Ethics Committee Address
Street address City Postal code Country
University Services, Joensuu Campus, P.O.Box 111 Joensuu FI-80101 Finland
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes Ghana Health Service Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Accra P.O.Box MB 190 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Gestational age At the onset of labour. At delivery.
Secondary Outcome Birthweight Immediately after delivery.
Secondary Outcome Back pains / pelvic pain In the course of the study.
Secondary Outcome Premature uterine contractions In the course of the study.
Secondary Outcome Back pains / pelvic pain In the course of the study.
Secondary Outcome Premature uterine contractions In the course of the study.
Secondary Outcome Mode of delivery At birth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Korle-Bu Teaching Hospital Accra Ghana
Mamprobi Polyclinic Accra Ghana
Ridge Hospital Accra Ghana
Achimota Hospital Accra Ghana
Kaneshie Polyclinic Accra Ghana
Legon Hospital Accra Ghana
Atibie Government Hospital Atibie Ghana
Komfo Anokye Teaching Hospital Kumasi Ghana
Cape Coast Teaching Hospital Cape Coast Ghana
Dansoman Polyclinic Accra Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
None None None None
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Kimmo Räsänen University of Eastern Finland Kuopio FI.70211 Finland University
Primary Sponsor Emma Kwegyir-Afful University of Eastern Finland Kuopio FI-70211 Finland University
COLLABORATORS
Name Street address City Postal code Country
Dr. Jos Verbeek Finnish Institute of Occupational Health, Cochrane Occupational Safety and Health Review Group Kuopio 70101 Finland
Professor J.D. Seffah University of Ghana Medical School Accra Ghana
Dr. Lydia Aziato School of Nursing, University of Ghana Accra P.O. Box LG 43 Ghana
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kimmo Räsänen kimmo.rasanen@uef.fi +358407700606 Yliopistonranta 1 C, B/3rd floor.Canthia
City Postal code Country Position/Affiliation
Kuopio FI-70211 Finland Lecturer
Role Name Email Phone Street address
Public Enquiries Emma Kwegyir-Afful emmakwe@uef.fi +358404495521 Erämiehenpolku 8 as 23
City Postal code Country Position/Affiliation
Vaasa 65370 Finland Doctoral Student
Role Name Email Phone Street address
Scientific Enquiries Emma Kwegyir-Afful emmakwe@uef.fi 0404495521 Erämiehenpolku 8 as 23
City Postal code Country Position/Affiliation
Vaasa 65370 Finland Doctoral Student
REPORTING
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