1. Does Formula Advertising During Pregnancy Affect Breastfeeding Initiation or Duration? Cynthia R Howard MD, MPH Associate Professor of Pediatrics The University of Rochester School of Medicine and Dentistry Pediatric Director of the Mother Baby Unit The Rochester General Hospital

2. Antenatal Formula Advertising and the Effect on Breastfeeding  Funded by a research grant from the Bureau of Maternal and Child Health (MCJ 360752)  Conducted between 10/94 and 12/97  Co investigators  Fred M Howard MD, FAACOG  Ruth Lawrence MD, FAAP  Elena Andresen, Ph.D.  Michael Weitzman MD, FAAP

3. Prenatal Formula Advertising  Background  Prevalence Data  Survey of expectant women  Survey of Obstetrician Gynecologists  Results of the RCT

4. "A pair of substantial mammary glands has the advantage over the two hemispheres of the most learned professor's brain in the art of compounding a nutritious fluid for infants" Oliver Wendell Holmes Oliver Wendell Holmes Breast or Bottle

5. Healthy Children Goals  2010 Goals  Initiation 75%  Duration to 5-6 months 50%; 12 months 25%  1998 Northeastern US  Initiation 64%  Duration to 6 months 29%; 12 months 16%  Rochester data  ~20-30% of women breastfeed for <= 1 month Months

6. Background  Obstetricians have begun distributing formula company produced infant feeding education materials and formula samples to their patients during prenatal care

7. Is this practice harmful?  No studies of the effects of formula advertising to pregnant women on breastfeeding initiation or duration  Several existing studies of the effects of formula samples and advertising on breastfeeding duration

8. Formula Discharge Packs  The postpartum distribution of commercial as compared to non-commercial discharge packs shortens breastfeeding duration  RP of termination at 1 month 1.4 (1.0;2.1)  RP of less than full breastfeeding at 1 month 1.1(1.0;1.3)  RP of termination at 4 months 1.2 (1.0;1.5) R. Perez-Escamilla et al. Infant feeding policies in maternity wards and their effect on breast-feeding success: An analytical overview. American Journal of Public Health 84 (1):89-97, 1994.

9. Prenatal Education About Infant Feeding  Survey of 136 consecutive women interviewed during their peripartum hospitalization   82% received infant feeding educational materials during prenatal care   64% published by a formula company   64% reported the receipt of a free formula offer   90% of these offers were obtained from the woman’s prenatal care provider Howard, Howard, Weitzman Birth 21:1, March 1994

10. Survey of Obstetrician Gynecologist  Obstetricians in Monroe County New York  78% response rate to mailed survey  104 practicing obstetricians  Formula company produced infant feeding literature (41%), pregnancy literature (57%) and free formula offers (61%) were commonly used C. R. Howard, S. J. Schaffer, and R. A. Lawrence. Attitudes, practices, and recommendations by obstetricians about infant feeding. Birth 24 (4):240-246, 1997.

11. Objectives To compare the effect of formula company-produced materials about infant feeding to breastfeeding promotion materials without formula advertising on breastfeeding ¬ Initiation ­ Duration  Early termination (in- hospital and <= 2 weeks)  Exclusive, full, and overall duration  Attainment of breastfeeding goals ® Examine the effect on ‘vulnerable’ groups of women C. R. Howard et al. Obstetrics & Gynecology 95 (2):296-303, 2000.

12. Study Design/Methods  Randomized, investigator blinded clinical trial  547 women randomized at first prenatal visit to receive infant formula company produced (commercial) or specially designed (research) infant feeding educational materials  Infant feeding method observed at delivery  Prospective telephone follow-up (2, 6, 12 and 24 weeks) of the mothers who chose to breastfeed their infants C. R. Howard et al. Obstetrics & Gynecology 95 (2):296-303, 2000.

13. Study Design

14. Study Design: Breastfeeding Women

15. Participant Follow-up  547 Randomized  71 lost due to miscarriage, 26 relocation, 3 randomization non-pregnant, 3 multiple gestation  444 Delivered  311 Breastfeeding Women  2 missed, 15 ineligible, 15 refused f/u, 11 lost to f/u before 24 weeks postpartum  Total Losses 26.7% (146 out of 547) C. R. Howard et al. Obstetrics & Gynecology 95 (2):296-303, 2000.

16. Selected Characteristics of Study Participants (N=444)

18. Analyses The effect of the Commercial (C) Vs. Research (R) pack was tested on the relevant feeding outcomes.  Continuous outcomes (e.g. breastfeeding duration)  Kaplan Meier and Cox proportional hazards analyses  Discrete Outcomes (e.g. initiation, in-hospital termination)  Chi square and logistic regression analyses  p values <=.05 considered statistically significant

19. Breastfeeding Initiation (n=444)

20. Termination of Breastfeeding Prior to Hospital Discharge (n=311) * Fisher’s exact two tailed test

21. Termination of Breastfeeding Prior to Hospital Discharge SUBJECTS MODEL COVARIATES RR/OR (95% CI) P VALUE IN MODEL 311Unadjusted5.801.25-54.01.02 Adjusted Commercial Pack10.281.30-81.18.03 Plan to Work1.060.80-1.41 Previously Breastfed1.480.38-5.75 Not Married1.370.20-9.15 Maternal Age0.910.78-1.07 SES0.990.96-1.02

22. Termination of Breastfeeding at or Before Two Weeks Postpartum (n=294) Adjusted for age, return to work, breastfeeding experience, MS and SES

23. In-Hospital Termination  Rate in Research group (control)  2/148 = 1.4%  Rate in Commercial group (treatment)  12/163 = 7.4%  Absolute Risk Increase = Tx - Control  7.4% - 1.4%= 6.0%

24. In-Hospital Termination  Number Needed to Harm  1.0/.06 = 16.7  For every 17 women exposed to commercial materials prenatally, 1 will quit breastfeeding before hospital discharge due to the exposure

25. Breastfeeding Duration Initiation Day 0 1st liquid or solid food Day 30 Daily liquid or food Day 60 Terminate Day 90 Exclusive 30 days Full 60 days Overall 90 days

26. Mean Duration of Breastfeeding (n=294) p>.05

27. Vulnerable Women: Subgroup Analyses  Low educational attainment (<= 12 years)  Primiparous women  Delivery by C-section  Shorter or non-specific goals for breastfeeding  less than 12 weeks or no specific goal (43% of participants)

28. Overall Breastfeeding Duration According to Breastfeeding Goal Months

29. Full Breastfeeding Duration According to Breastfeeding Goal Months

30. Exclusive Breastfeeding Duration According to Breastfeeding Goal Months

31. Mean Duration of Breastfeeding Among Women with Shorter Goals (n=128) All outcomes p<.05

32. Attainment of Breastfeeding Goal (n=225)

33. Limitations  Study population  Intervention  Breastfeeding supportive environment  hospital setting  follow-up  Formula advertising from other sources

34. Conclusions  Obstetrical distribution of formula company promotional materials does not significantly affect maternal choice of infant feeding method  The risk that women will terminate breastfeeding in the early postpartum time period, however, is substantially increased.  Women with uncertain personal breastfeeding goals or goals of less than 12 weeks are at risk for significantly shortened breastfeeding duration C. R. Howard et al. Obstetrics & Gynecology 95 (2):296-303, 2000.

35. Conclusions  Educational materials about infant feeding should unequivocally support breastfeeding as optimal nutrition for infants; formula promotion products should be eliminated from prenatal settings C. R. Howard et al. Obstetrics & Gynecology 95 (2):296-303, 2000.

36. Thanks   Bureau of Maternal and Child Health   Participating Obstetric Practices  Panorama Obstetrics and Gynecology  Westridge Obstetrics and Gynecology  Faculty Practice of Rochester General Hospital   The Departments of Obstetrics & Gynecology and Pediatrics at Rochester General Hospital