NCT02394574

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P50-P75 for not_applicable pregnancy

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

October 16, 2024

Status Verified

December 1, 2022

Enrollment Period

3 years

First QC Date

March 13, 2015

Last Update Submit

October 11, 2024

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • 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.

    At birth

Secondary Outcomes (1)

  • Reduction in personal exposure to PM2.5, CO and PAH

    At birth

Study Arms (2)

Clean Cookstove

ACTIVE COMPARATOR

Subjects will use ethanol stoves using bioethanol

Other: Clean Cookstove

Traditional Cookstove

OTHER

Subjects will use traditional firewood or kerosine cookstove and receive education on how to reduce air pollution exposures

Other: Traditional Cookstove

Interventions

Clean CookstoveOTHER

Ethanol

Clean Cookstove
Traditional CookstoveOTHER

Firewood / Kerosene

Traditional Cookstove

Eligibility Criteria

AgeUp to 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Medicine. University of lbadan, Ibadan

Ibadan, Nigeria

Location

Related Publications (3)

  • 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.

    PMID: 35901049DERIVED

  • 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.

    PMID: 34187482DERIVED

  • 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.

    PMID: 28081369DERIVED

Study Officials

  • Christopher Olopade, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2015

First Posted

March 20, 2015

Study Start

September 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

October 16, 2024

Record last verified: 2022-12

Locations

NG(1)