PregnancyHAPNCT02394574
Household Air Pollution and Pregnancy Outcome
A study testing Clean Cookstove and Traditional Cookstove in people with Pregnancy, run by University of Chicago at 1 site in Nigeria.
Trial summary
Exposure to Household air pollution (HAP) from burning biomass fuels is responsible for an estimated 2.5 million premature deaths and 3.7% of the loss of disability-adjusted life years (DALY) every year in developing countries.52-54 Of all environmental risks, such as unsafe water, poor sanitation, climate change and… Read more about this study
- Who is it for?
- Ages Up to 35 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Clean Cookstove and Traditional Cookstove
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 1 siteNigeria
- Study dates
- Sep 2012to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 35 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pregnant women who present to the hospital
- Who cook exclusively with either kerosene or firewood
- Before the fourteenth week of pregnancy as determined by ultrasound imaging
Who cannot join
- Smoking women or women with smoking family members
- Women with a high-risk pregnancy defined as:
- Women with uncontrolled hypertension
- Women greater than 35 years old carrying their first child
- Women having triplets or more
- Women who have had a previous C-section
- Women carrying babies with fetal abnormalities or as determined by the obstetrician.
Trial locations and contacts
1 site in 1 country.
About this study
Exposure to Household air pollution (HAP) from burning biomass fuels is responsible for an estimated 2.5 million premature deaths and 3.7% of the loss of disability-adjusted life years (DALY) every year in developing countries.52-54 Of all environmental risks, such as unsafe water, poor sanitation, climate change and lead exposure, HAP accounts for the most mortality and DALY.55 Despite the magnitude of the problems associated with HAP, research on its health effects has been hindered by lack of accurate data on exposure and health outcomes. There are few studies available that report HAP exposures and development of adverse pregnancy outcomes from households using biomass fuels.
- Conditions
- Pregnancy
- Being tested
- Clean Cookstove, Traditional Cookstove
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clean CookstoveOther
Ethanol
Traditional CookstoveOther
Firewood / Kerosene
| Study group | Role | What they receive |
|---|---|---|
| Clean Cookstove | Active comparator | Subjects will use ethanol stoves using bioethanol Receives: Other: Clean Cookstove |
| Traditional Cookstove | Other | Subjects will use traditional firewood or kerosine cookstove and receive education on how to reduce air pollution exposures Receives: Other: Traditional Cookstove |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Pregnancy Outcomes
(first trimester miscarriages, intrauterine growth retardation, low birth weight (300gm less weight in controls relative to intervention group, premature deliveries (deliveries before 37 weeks of pregnancy) and still births.
Measured: At birth
Secondary outcomes (1)
Reduction in personal exposure to PM2.5, CO and PAH
Reduction in personal exposure to PM2.5, CO and PAH in the Ethanol intervention group relative to the control (kerosene/firewood) group
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2015 (estimated)
- Study startSep 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Olopade, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02394574
- Sponsor's protocol ID
- 12-1460
- Acronym
- HAP
- Status last verified
- Dec 2022
- First submitted
- 13 Mar 2015
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Deji-Abiodun O, Adedokun B, Alexander D, Dutta A, Ibigbami T, Olamijulo J, Adepoju D, Adekunle S, Ojengbede O, Olopade CO. Impact of prenatal maternal psychological distress on fetal biometric parameters in household air pollution-exposed Nigerian women. PLoS One. 2022 Jul 28;17(7):e0272053. doi: 10.1371/journal.pone.0272053. eCollection 2022.
PubMed 35901049Dutta A, Alexander D, Karrison T, Morhasson-Bello O, Wilson N, Atalabi OM, Adu D, Ibigbami T, Adekunle S, Adepoju D, Olamijulo J, Akinwunmi O, Afolabi OS, Deji-Abiodun O, Adedokun B, Aschebrook-Kilfoy B, Ojengbede O, Olopade CO. Household air pollution, ultrasound measurement, fetal biometric parameters and intrauterine growth restriction. Environ Health. 2021 Jun 23;20(1):74. doi: 10.1186/s12940-021-00756-5.
PubMed 34187482Alexander D, Northcross A, Wilson N, Dutta A, Pandya R, Ibigbami T, Adu D, Olamijulo J, Morhason-Bello O, Karrison T, Ojengbede O, Olopade CO. Randomized Controlled Ethanol Cookstove Intervention and Blood Pressure in Pregnant Nigerian Women. Am J Respir Crit Care Med. 2017 Jun 15;195(12):1629-1639. doi: 10.1164/rccm.201606-1177OC.
PubMed 28081369
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Household Air Pollution and Pregnancy Outcome
- ClinicalTrials.gov ID
- NCT02394574
- Acronym / sponsor ID
- HAP / 12-1460
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exposure to Household air pollution (HAP) from burning biomass fuels is responsible for an estimated 2.5 million premature deaths and 3.7% of the loss of disability-adjusted life years (DALY) every year in developing countries.52-54 Of all environmental risks, such as unsafe water, poor sanitation, climate change and lead exposure, HAP accounts for the most mortality and DALY.55 Despite the magnitude of the problems associated with HAP, research on its health effects has been hindered by lack of accurate data on exposure and health outcomes. There are few studies available that report HAP exposures and development of adverse pregnancy outcomes from households using biomass fuels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clean Cookstove | Active comparator | Other: Clean CookstoveSubjects will use ethanol stoves using bioethanol |
| Traditional Cookstove | Other | Other: Traditional CookstoveSubjects will use traditional firewood or kerosine cookstove and receive education on how to reduce air pollution exposures |
Who may qualify
- Ages
- Up to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Pregnant women who present to the hospital
- Who cook exclusively with either kerosene or firewood
- Before the fourteenth week of pregnancy as determined by ultrasound imaging
Key exclusion criteria (7 listed)
- Smoking women or women with smoking family members
- Women with a high-risk pregnancy defined as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clean CookstoveEthanol | Other | Clean Cookstove |
| Traditional CookstoveFirewood / Kerosene | Other | Traditional Cookstove |
Primary outcome
Adverse Pregnancy Outcomes
Time frame: At birth
(first trimester miscarriages, intrauterine growth retardation, low birth weight (300gm less weight in controls relative to intervention group, premature deliveries (deliveries before 37 weeks of pregnancy) and still births.
1 secondary outcome
Reduction in personal exposure to PM2.5, CO and PAH
Time frame: At birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Derived from this study: PubMed 35901049Deji-Abiodun O, Adedokun B, Alexander D, Dutta A, Ibigbami T, Olamijulo J, Adepoju D, Adekunle S, Ojengbede O, Olopade CO. Impact of prenatal maternal psychological distress on fetal biometric parameters in household air pollution-exposed Nigerian women. PLoS One. 2022 Jul 28;17(7):e0272053. doi: 10.1371/journal.pone.0272053. eCollection 2022.
- Derived from this study: PubMed 34187482Dutta A, Alexander D, Karrison T, Morhasson-Bello O, Wilson N, Atalabi OM, Adu D, Ibigbami T, Adekunle S, Adepoju D, Olamijulo J, Akinwunmi O, Afolabi OS, Deji-Abiodun O, Adedokun B, Aschebrook-Kilfoy B, Ojengbede O, Olopade CO. Household air pollution, ultrasound measurement, fetal biometric parameters and intrauterine growth restriction. Environ Health. 2021 Jun 23;20(1):74. doi: 10.1186/s12940-021-00756-5.
- Derived from this study: PubMed 28081369Alexander D, Northcross A, Wilson N, Dutta A, Pandya R, Ibigbami T, Adu D, Olamijulo J, Morhason-Bello O, Karrison T, Ojengbede O, Olopade CO. Randomized Controlled Ethanol Cookstove Intervention and Blood Pressure in Pregnant Nigerian Women. Am J Respir Crit Care Med. 2017 Jun 15;195(12):1629-1639. doi: 10.1164/rccm.201606-1177OC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Olopade, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clean Cookstove and Traditional Cookstove in people with Pregnancy, run by University of Chicago at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Pregnancy Outcomes (time frame: At birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02394574, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.