Clinical trial NCT02394574: Household Air Pollution and Pregnancy Outcome
Official title: Household Air Pollution and Pregnancy Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2015-03-20
Enrollment: 307
Sex: FEMALE
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Adverse Pregnancy Outcomes
timeFrame: At birth
Secondary outcomes:
measure: Reduction in personal exposure to PM2.5, CO and PAH
timeFrame: At birth
Other outcomes:
Locations:
city: Ibadan
country: Nigeria
facility: College of Medicine. University of lbadan, Ibadan
Study officials:
affiliation: University of Chicago
name: Christopher Olopade, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Dutta 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.
citation: Alexander 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.