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.: PACTR202111534227089 Date of Approval: 16/11/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Household Air Pollution Intervention and Pregnancy Outcome
Official scientific title Household Air Pollution Intervention to Improve Birth Outcomes and Infant Acute Respiratory Infections in South Gondar Zone, Ethiopia: a randomized control trial study
Brief summary describing the background and objectives of the trial Globally, nearly 3 billion people burn biomass fuel to provide energy for cooking, heating and lighting. Burning of these solid biomass fuels with inefficient or traditional stoves are associated with many health problems in developing countries including Ethiopia. Infants and young children are particularly susceptible to severe respiratory infections from household air pollutants due to their undeveloped respiratory defense mechanisms. Growing evidences also linked exposure from solid biomass smoke during pregnancy with poor pregnancy outcomes such as poor fetal growth, low birthweight and preterm births. These adverse pregnancy outcomes are strongly linked to fetal and neonatal mortality and morbidity, impairing growth and cognitive development and leading to chronic diseases later in life. To combat the burden of household air pollution, preventive actions are urgently needed and improved stoves were suggested by world health organization as prioritized option for safe transition to clean cooking. But evidences for the impact of these improved stoves on health outcomes remains elusive which needs research to quantify its impact on relevant health problems. In addition, assessing the community perceptions towards the health risk of household air pollution and the health benefit of improved stove intervention in the baseline survey will help for better adoption and utilization of improved stove. Therefore, the aim of this study is to quantify the impact of improved multipurpose Mirt (best) stove intervention on pregnancy outcomes and infant acute respiratory infections among pregnant women and their new born babies in south Gondar Zone, North Central Ethiopia
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/12/2021
Actual trial start date 16/11/2022
Anticipated date of last follow up 30/11/2022
Actual Last follow-up date 30/07/2023
Anticipated target sample size (number of participants) 455
Actual target sample size (number of participants) 422
Recruitment status Completed
Publication URL Health risk perceptions of household air pollution and perceived benefits of improved stoves among pregnant women in rural Ethiopia: a mixed method study
Secondary Ids Issuing authority/Trial register
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Randomized Control Trial Not applicable Before the second trimester of their pregnancy to the 6 months age of their new born babies which is nearly 13 months The traditional open burning stove will be replaced with a commercially available and locally installed multiple burner biomass stove with a chimney outlet called ‘Mirt stove’ . The stove consists of a primary burner (for Injejera baking) and at least one secondary burners (for cooking different food items) and a chimney. It is well-accepted, culturally appropriate, locally sourced, and functioned well when maintained correctly. It has a specific fuel consumption reduction of 40% to 50% compared to the open-fire traditional stove. Mirt stove is accepted by the Amhara Regional Water and Energy Bureau as clean and fuel saving cook stove and is being promoted to rural households since 1998 by the German technical assistance agency GIZ. There are trained stove producers who build this stove and install by moving from house to house. These trained stove installers will install and household members will be trained on how to use and maintain the stove. The griddle can hold 2 to 3 pots at once for multiple purpose. In addition to installation the new stove, training and demonstration in the use and maintenance of the stoves will be given and reinforced regularly throughout the follow-up period by field workers. Stove use monitoring will be done through visiting households to encourage and record stove use 324
Control Group No Intervention not applicable nearly for 13 months no intervention 324 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Aged 18-38 years -In her first or second trimester gestation (gestational age ≤ 18 weeks to be determined by self-reported first day of last menstrual period (LMP) or ultrasound (as appropriate), -Exclusively use traditional biomass fueled stove, - The primary cook in her household -Carrying a live singleton fetus -Healthy women -Pregnant women who have plan to move permanently outside the study area in the next 12 months, l -Pregnant women who is likely to use clean stove predominantly in the near future -Pregnant women are engaged in local alcohol production and -Pregnant women who do not have enclosed main cooking area (kitchen) structure Adult: 19 Year-44 Year 18 Year(s) 38 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 13/10/2021 IRB of health science institute
Ethics Committee Address
Street address City Postal code Country
not applicable Jimma 378 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome stillbirth, low birth weight, abortion, miscarriage which will be measured as combined variable named adverse pregnancy outcome within 24 hours after birth
Secondary Outcome Acute Respiratory Infections ARIs every month for 6 months
Secondary Outcome household air pollution concentration twice
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Debre Tabor University not applicable Debre Tabor Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
PhD student research fund Not applicable Debre Tabor Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Debre Tabor University not applicable Debre Tabor Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Habtamu Demelash enyew29@gmail.com +251931590256 not applicable
City Postal code Country Position/Affiliation
Debre Tabor Ethiopia PhD student
Role Name Email Phone Street address
Public Enquiries Seid Tiku seidtiku@yahoo.com +25113296056 not applicable
City Postal code Country Position/Affiliation
Jimma Ethiopia Senior Lecturer and Researcher
Role Name Email Phone Street address
Scientific Enquiries Abebe Beyene abebebh2003@yahoo.com +251912888500 not applicable
City Postal code Country Position/Affiliation
Jimma Ethiopia senior lecturer and researcher
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study will be provided to qualified researchers with academic interest in household air pollution and related health problems. Approval of the request and execution of all applicable agreements will be prerequisite to the sharing of data with the requesting party Clinical Study Report,Informed Consent Form,Statistical Analysis Plan Data requests can be submitted starting 6 months after article publication and the data will be made accessible for up to 12 months. Extensions will be considered on a case-by-case basis Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 15/08/2024 30/08/2023
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 15/08/2024 Result - 15/08/2024 Result - 15/08/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information