1. Progress Report Moscow Region Infant Study
June 22, 2005
Santa Barbara, CA

2. Objectives
To measure the birth prevalence and range of alcohol-related features and neurobehavioral impairment among children born to women who report moderate to heavy amounts of alcohol by utilizing methods to permit earlier diagnosis of alcohol-related effects
To evaluate the contribution of maternal nutritional factors to increased risk for prenatal growth deficiency, neurobehavioral impairment, and alcohol-related physical features in infants prenatally exposed to moderate to heavy amounts of alcohol by conducting a trial of supplement intervention and measuring micronutrient levels in maternal blood

3. Progress Jan 05-June 05
March, 2005, Carl Keen completed site visit to Center for Biotech Medicine (minerals), Laboratory of Anna Kalinina (vitamins), Friendship University (biomarkers, DNA banking)
Resolved problems with CRDF
Completed and tested screener database; completed and implemented use of extended alcohol and control database
Completed ultrasound data collection tool and data dictionary
Mentor training for infant testers – 2 full day sessions with each of four testers – ongoing practice sessions
Initiated recruitment of subjects

4. Screening results
4 ladies consultation services have performed preliminary interviews with 413 pregnant women
Data has been entered into the screening database as of April, 2005
Based on initial screening guidelines for subject selection 12 percent of women are meeting the criteria for exposed, and 27 percent are meeting the criteria for unexposed

5. Characteristics of the sample population
Nationality Russian
377 (91.3%)
Maternal Age (yrs)
25.20  5.52
(Range 15-44)
Paternal Age (yrs)
28.87  6.65
(Range 17-63)
Marital Status
Married
Unmarried;living with partner
Unmarried;not living with partner
225 (54.5%)
153 (37.0%)
35 (8.5%)
Gestational Age at Screening (wks)
14.70  6.7
(Range 3-37)

6. Demographics and pregnancy history
Maternal Education (yrs)
< 9 years
years
years
> 15 years
10 (2.4%)
102 (24.7%)
215 (52.0%)
86 (20.8%)
Gravidity
Primigravid
Range 1-14
201 (48.7%)
Parity
Primiparous
Range 0-5
284 (68.8%)
Previous spontaneous abortion or stillbirth
(among multigravid)
Range 0-9
47 (22.2%)
Previous pregnancy termination
147 (69.3%)

7. Medication and illicit drug use
Any medication
vitamins
analgesics, antihistamines, antifungal
antiretrovirals, tuberculosis drugs
thyroid medication
oral steroids
herbs
84 (20.3%)
56 (13.6%)
15 (3.6%)
4 (0.9%)
3 (0.7%)
Illicit drugs
marijuana
amphetamine
cocaine
opiates
inhalants
other
2 (0.5%)

8. Smoking in the last month
*smoking among exposed 63%; smoking among controls 23%

9. Alcohol history
372 (90.1%) of women interviewed report being ever-drinkers
Among ever-drinkers, mean age at onset of drinking  2.33 yrs (range 5-32)

10. Quantity/frequency

11. Quantity/frequency
94% of ever drinkers report some alcohol in pregnancy
52% of ever drinkers report some alcohol after recognition of pregnancy

12. Tolerance

13. Signs of abuse in the last year

14. Validity of maternal report in Russia?

15. Alcohol consumption by pregnant women in Russia
1022 pregnant women in one Northwest Russian maternity house who delivered live born singletons completed a questionnaire at first prenatal visit
Alcohol consumption reported by 26% of responders (40% non-responders)
Most reported drinking in very small quantities-primarily beer and wine
Drinkers had higher birth weight babies than non-drinkers (occasional drinkers adjusted birth weight 65 grams higher than non-drinkers; 95% CI, )
Grjibovski A et al, (2002) Paediatric and Perinatal Epidemiology;16:255-62
Grjibovski A et al, (2004) Acta Obstet Gynecol Scand;83:

16. Alcohol consumption by pregnant women in Russia
Preliminary data from 78 women interviewed at time of delivery in one birthing hospital in Moscow (Nemtsov et al – Moscow Institute of Psychiatry)
96.1% reported being ever drinkers
49.4% reported consuming some alcohol during pregnancy

17. Alcohol consumption by pregnant women in Russia
Alcohol Group
Adj. Mean BW ± SE
95% CI
Abstainer in pregnancy
3290 ± 66
3158, 3421
<1 drink/day in any week
3367 ± 69
3228, 3506
>4 drinks at least one occasion
2709 ± 200
2309, 3109
Adjusted for pre-pregnancy weight, smoking, sex of infant

18. Alcohol consumption by pregnant women in Russia
Alcohol Group
Adj. Mean BL ± SE
95% CI
Abstainer in pregnancy
51.4 ± 0.4
50.7, 52.2
<1 drink/day in any week
52.0 ± 0.4
51.2, 52.8
>4 drinks at least one occasion
48.9 ± 1.1
46.8, 51.1
Adjusted for pre-pregnancy weight, smoking, sex of infant

19. Alcohol consumption by pregnant women in Russia
Alcohol Group
Adj. Mean BOFC ± SE
95% CI
Abstainer in pregnancy
34.8 ± 0.2
34.3, 35.3
<1 drink/day in any week
34.7 ± 0.3
34.2, 35.2
>4 drinks at least one occasion
33.7 ± 0.7
32.3, 35.2
Adjusted for pre-pregnancy weight, smoking, sex of infant

20. Knowledge regarding FAS among pregnant women in Russia
Alcohol Group
Heard of FAS
Abstainer in pregnancy
33%
<1 drink/day in any week
20%
> 4 drinks at least one occasion 0%

21. Plans for coming year
Continue recruitment and evaluate projected sample size through Year 3
Submit manuscript on screening data
Preliminary analysis of micronutrient measures at enrollment, and biomarker measures at enrollment v. maternal report