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Preliminary Observations in RCT Study Investigating Impact of
Bioethanol Stove on Pregnancy Outcomes in Nigeria
Sola Olopade, MD, MPH Professor of Medicine Center for Global Health University of Chicago
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Presentation Outline
• Provide overview of study design of first RCT evaluating impact of the CleanCook stove and bioethanol on pregnancy outcome
• Discuss preliminary results – Baseline distributions by intervention arm – Personal exposures – Adoption – Intra uterine growth curves – Birth outcomes
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HAP and Pregnancy Outcome Study Objectives
• Investigate ability of ethanol stove and bioethanol to reduce personal exposure to PM2.5, CO and PAH and improve pregnancy outcome in women who cook primarily with firewood
• Establish exposure-response relationship between pollutants and health outcomes
• To evaluate stove use/likability of the ethanol stoves by temperature based monitoring and compare with health outcomes
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HAP and Pregnancy Outcome Hypothesis
• Ethanol stove and bioethanol fuel use will reduce pregnant women’s exposures to PM2.5, PAH, and CO relative to kerosene and firewood and reduce adverse pregnancy outcomes.
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The CleanCook Tier 4 Stove*
MacCarty N: Energy for Sus Dev 2010:161-171
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Local Primary Health Center
Clinic Visit 1: Recruitment, Consent, Questionnaire, Diet Survey, Spirometry
Home Visit 1: Initial Home Visit
Control (kerosene/Wood*) (N = 150)
CleanCook Stove (N = 150)
Randomized 16-18 weeks
Clinic Visit 2: Ultrasound, Blood Draw CBC, Biomarkers of
Nutrition and Malaria
*Original design was Ethanol vs. Wood
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Clinic Visit 3: 20 Week Gestational Age (Ultrasound)
Clinic Visit 4: 26 Week Gestational Age (Ultrasound, Blood Draw, Spirometry)
Clinic Visit 5: 30 Week Gestational Age (Ultrasound)
Clinic Visit 6: 34 Week Gestational Age (Ultrasound, Blood Draw, Spirometry)
Home Visit 2: 19 Weeks Gestational Age (1st Exposure Monitoring Visit)
PEM-72hrs PM2.5, CO,
PAH
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Home Visit 3: 35 Week Gestational Age (2nd Exposure Monitoring Visit)
Clinic Visit 7: 38 Week Gestational Age (Ultrasound)
Clinic Visit 8: Delivery (Pregnancy Outcomes)
Cord Blood and Placenta Collection*
*
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Exposure and Cookstove Monitoring
• 2nd and 3rd trimester • 72-hr continuous PM2.5 & CO • 72-hr integrated PAH (subset) • 12-20-hr GPS • SUMs placed on all homes in study homes • SUMs record temperature every 10 minutes
*SUMs = Stove Use Monitors
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Randomized Controlled Trial
307
153 CleanCook
stoves
154 Kerosene
Vs. Firewood
Last delivery expected by August 2015
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Pregnancy Outcome Measures • Miscarriage • Preterm delivery • Intrauterine growth rate
– Head and abdominal circumference, femur length, crown rump length etc
• Birth weight, length and head circumference
• Apgar scores • Stillbirth
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Other Outcome Measures
• Pulmonary function • BP changes • Biomarkers
– Nutrition – Oxidative damage – Systemic inflammation
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Baseline Distribution by Intervention Arm
Ethanol (153)
Control (150)
Clinic Agbongbon
72 (47.4%)
68 (45.3%)
Oranyan 43 (28.3%) 45 (30.0%) Olorisaoko 37 (24.3%) 37 (24.7%) Missing 1 Parity
<4 children 143 (94%) 140 (93.3%) >4 children 9 (5.9%) 10 (6.7%) Missing 1
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Baseline Distribution by Intervention Arm
Ethanol (n=153)
Control (n=150)
Gestational age at entry
Mean, SD 13.1, 3.0 13.2, 3.2 (range) (6.7-18) (2.6-18) Missing 3 2 Education Level
None 43 (28.3%) 46 (32.2%) Primary 15 (9.9%) 16 (11.0%) Senior Secondary 67 (44.1%) 56 (38.5%)
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Obstetrics History at Baseline Ethanol n=153
Control n=150
Prior miscarriage
Yes 43 (28.5%) 42 (28.8%)
No 109 (71.7%) 104 (71.2%)
Missing 1 4
Miscarriages Nos.
None 109 (71.7%) 104 (71.2%)
1 32 (21%) 33 (22.6%)
2 8 (5.3%) 6 (4.1%)
3 3 (2%) 3 (2%)
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Main Type of Stove at Entry
Variable Ethanol (n=153)
Control (n=150)
Three stone 42 (29.2%) 43 (30.7%)
Kerosene 98 (68.1%) 95 (67.9%)
Charcoal 3 (3%) 2 (1.4%)
Electric 1 (0.7%) 0
Missing 9 10
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Adoption of CleanCook Stove
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Personal CO Exposure
Control (ppm)
Intervention (ppm)
p-value
72 hour mean (SD)
3(4) 1(1) 0.06
Max 15 minute 41(38) 34(18) 0.05
Range 0 - 23 0 - 6
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Personal PM 2.5 Exposure
Intervention
(Ethanol) Control
(Kerosene)
PM 2.5 72 hr mean mg/m3 66.3
[21] (n=83)
87.4 [20]
(n=88)
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Preliminary Birth Outcome Data
Variable Ethanol (N=77)
Control* (N=70)
p-value
Preterm delivery
Yes 5 (6.5%) 7 (10%) 0.55
No 72 (93.5%) 63 (90%)
Stillbirths
Yes 2 (2.6%) 2 (2.9%) 0.40
No 75 (97.4%) 68 (97.1%)
Miscarriage
Yes 0 1(1.4%) 0.48
* Kerosene/Firewood
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Birth Outcome Collection Based on Delivery Location
Site Deliveries as % of total
Outcome data collected
Primary Health Center 170 (69.3%) 149 (87.6%)
Home 34 (13.8%) 25 (73.5%)
Church 21(8.57%) 19 (90.4%)
TBA 10 (4.08%) 7 (70%)
Mosque 2 (0.81%) 2 (100%)
Unknown 3 (1.22%) 0
Miscarriages 5 (2.04%) 0
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Preliminary Conclusions • The CleanCook and bioethanol combination
appears to reduce PM2.5 and CO exposures relative to Kerosene
• CleanCook stove is liked and being and is being adopted by Nigerian women.
• Preliminary exposure data indicates ethanol is less pollutant than Kerosene and biomass
• No appreciable difference in preliminary birth outcomes between ethanol and control group but over 50% of deliveries are still pending
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Research Team and Partners • Obstetrics and Gynecology
– Prof. Ojengbede and M Bello (Univ. of Ibadan)
• Exposure monitoring – Amanda Northcross, PhD (GWU), – Godson Ana, PhD and Donee Alexander, PhD (GACC)
• Healthy Life for All Foundation – T Ibigbami, J Olajumilo, D Adepoju and D Adu
• Laboratory studies – Prof Arinola, A Odetunde (Nigeria), Niu Qun (Chicago)
• Project Gaia (USA), HLF (Nigeria), Shell Foundation
Funding: Global Alliance for Clean Cookstoves
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Mother-Child Exposure to Biomass Smoke in Nigeria
WHO Conference for Life: 2006