Efficacy of a New Method of Family Planning for Breastfeeding Women

1. Efficacy of a New Method of Family Planning for Breastfeeding Women 2012 State of the Science Congress On Nursing Research

2. Research Team • Thomas Bouchard, BSc, MD, University of Calgary Department of Family Medicine. • Richard J. Fehring, PhD, RN, FAAN - professor Marquette University College of Nursing. • Mary Schneider, MSN, APRN - a doctoral student at Marquette University College of Nursing.

3. Introduction • The postpartum period is a challenging time for family planning, especially for women who breastfeed. • Breastfeeding delays the return of menses (lactational amenorrhea), but ovulation often occurs prior to first menses. • For this reason, a protocol was developed to assist women in identifying their return of fertility postpartum to avoid pregnancy.

4. Problem • The time from the birth of a baby until the resumption of regular menstrual cycles is known as the breastfeeding transition. • This transition is a difficult time for women who wish to use natural methods of family planning (NFP) to avoid pregnancy. • Likewise, it is a time when women who use NFP often get pregnant without intending to. • This is a problem because spacing of childbirth is healthier for the mother and baby, and because there can be serious reasons for not having a pregnancy soon after childbirth.

5. Stages of Breastfeeding Transition • Stage One: time from birth until first ovulation and first true menses - characterized by estrogen rises, follicular development, breakthrough bleeding, short luteal phase, • Stage Two: first 3-6 menstrual cycles after birth of child – often cycles have delayed ovulation and long cycle lengths. • Stage Three: regular menstrual cycles. • Method: monitoring estrogen rises and LH surge before first ovulation with electronic hormonal fertility monitor during the breastfeeding transition.

6. Cycle 0 dynamics

7. Stage Two

8. Literature review • Women using the Ovulation Method during breastfeeding had higher unintended pregnancy rate than non-breastfeeders (Labbok, 1991) • Users are confused about interpretation of their signs, especially if they had previously irregular cycles (Hatherley, 1985) • 2/3 of women ovulate before their first menses, and the return of menses is not always predictable (Campbell, 1993; Kennedy, 1995; Parenteau, 1984)

9. Efficacy Studies • NFP pregnancy rates at 12 months: • Klaus (OM) 1979 (N=109): 17% (>6 months) • Brown (OM+STM) 1985 (N=55): 14% • Hatherley (STM) 1985 (N=204): 11% • Perez (OM) 1988 (N=378): 11%, correct-use 2% • Labbok (OM) 1991 (N=205+110): 19% bf • Howard (Creighton) 1999: 24% • Fehring (MM) 2011: 5% (6 months pilot study) • Sinai (SDM) 2012: 11% (6 months after menses return)

10. LAM Efficacy • Recent LAM systematic review (van der Wijden): • Controlled studies 0.45 to 2.45% at 6 months • Uncontrolled studies 0 to 7.5% at 6 months • One study showed no difference in unintended pregnancy between women who were using LAM rules (Bellagio consensus 1988) vs those who were fully breastfeeding and amenorrheic • However most studies are based on 6 month survival

11. Purpose of Study • Pilot use of the postpartum protocol among 10 women who also monitored their cervical mucus demonstrated that the monitor would cut the estimated time of abstinence approximately in half (Fehring, 2004). • In a separate study including postpartum and regularly cycling women, the same researchers identified a typical use pregnancy rate of 5 per 100 womenover 6 months in the subset of 108 breastfeeding women (Fehring, 2011). • The purpose of the current study was to evaluate the efficacy and acceptability of this protocol for avoiding pregnancy among a larger group of postpartum breastfeeding women over a 12-month period.

12. Methods • Prospective 12-month longitudinal cohort study, • 198 postpartum women aged 20 to 45 (mean age of 30.2 years) were taught a protocol for avoiding pregnancy with online instruction. • Kaplan-Meier survival analysis was used to calculate pregnancy rates through the first 12 months postpartum. • Participants asked to respond to an online ease of use/acceptability survey at 1, 3, and 6 months of use.

13. Measurement of variables: • Unintended pregnancies were confirmed by an online pregnancy evaluation reviewed by two professional nurses. • Correct use and total unintended pregnancy rates were determined by survival analysis. • Acceptability/Ease of useof the protocol: was measured by asking the woman participant to respond to a 10 item questionnaire developed by Severy. Uses a 1-7 rating scale with total score from 0 – 70. (Internal consistency – Cronbach ‘s Alpha = 0.83 – 0.91)

14. The Fertility Monitor ClearBlue Easy Monitor Three Levels of Fertility

15. The Breastfeeding Protocol • Trigger a cycle by pushing the “M” button on the monitor. • Fast forward the monitor to day 5. • The next 20 days the monitor will ask for a test. • Test your first morning urine every other day. • When a “high” is recorded, test the urine every day. • Re-trigger the monitor and fast forward every 20 days. • Continue steps 1-6 until you detect a Peak reading and resume menses. • Intercourse instructions are: • To avoid pregnancy, refrain from intercourse on High and Peak days and three full days after the last Peak day. R. Fehring, M. Schneider, & M.L. Barron, (2005) “Protocol for determining fertility while breast-feeding,” Fertility and Sterility 84: 805-7. (N=10; Fertility monitor + mucus).

16. Breastfeeding protocol

17. The Web Site and Fertility Chart Marquette NFP Web Site Example Breastfeeding Chart

18. Results

19. Demographics (N=198) • Age female 30.2 ± 4.9 • Years Married 5.3 ± 4.3 • Living Children 2.9 ± 1.7 • Ethnicity 73% Caucasian • Religion 79% Catholic

20. Correct Use Pregnancies • There were 2 unintended pregnancies per 100 women with correct use during the first 12 months postpartum. • The method-related pregnancies occurred in: (i) the amenorrheic period (in the 9th month postpartum), (ii) the 3rd cycle after the return of menses (in the 12th month postpartum).

21. Typical use survival over 12-months

22. Unintended Pregnancy I was using billings on that day I thought it was my basic infertile pattern which now I know it was not. I am just really upset that I didn't know about the Marquette method earlier due to having a child just turning 2 another one 10 months.

23. Unintended Pregnancy • Day -6. Cycle 3.

24. Acceptability • 55.4 (SD=8.8) at one month (N=143) • 57.7(SD=8.3) at three months (N=93), and • 58.3(SD=7.7) at six months (N=57) of use. • Repeated measure ANOVA of the three time periods showed no significant effect (F(2,21) = 0.40, p = 0.67). • 4.8 item #1 (“Including website in your daily routine”) • 6.2 item #4 (“Your overall opinion of this website”) and • 6.2 item #7 (“Ease of use of the website”) at 6 months of use.

25. Discussion - Efficacy • The typical (or total) pregnancy rate of 8 per 100 women over 12 months is lower than past studies on the Marquette Method in regularly cycling women (11 to 14 per 100 woman years) and lower than other NFP methods during the breastfeeding transition (11 to 24 per 100 woman years). • However, given that this was not a randomized controlled trial, we cannot be sure whether the lower pregnancy rates are an improvement on previous studies or whether they reflect a difference in participant characteristics.

26. Discussion - Acceptability • Although no significant increase, the acceptability scores show a high acceptance of the protocol and website charting system. • The scores are comparable to those found with regular cycling women in an earlier pilot study. • Individual item means indicate that the website was well-liked and easy to use (i.e., items 4 and 7), but it seems that including online menstrual cycle charting into a daily routine was the hardest to do (i.e., item 1). • Most participants rated that the website and protocol was an improvement over other natural fertility regulation methods(item 9).

27. Limitations • Lack of a control or comparison group. • Relatively highly educated, Caucasian sample of women who were attracted to the website and method, which limits the study’s generalizability. • Cost of the fertility monitor might be prohibitive for some women. • Attrition over time

28. Protocol Modifications • Fertility begins on day 10 of the 1st cycle after the return of menses, • day 9 in the 2nd cycle, • day 8 in the 3rd cycle, • day 7 in the 4th cycle, and • day 6 from the 5th cycle onward. However, if the monitor records a high reading prior to these days, then fertility starts on the day of the first high reading. • (Optional) Beginning on day 6 in the first menstrual cycle postpartum, women may do a second test for the LH surge in the evening with a separate LH test kit.

29. Future Research • Testing modified protocol • Testing protocol chartings system and app • Comparing protocol with LAM or other natural methods – e.g., the Standard Days Bridge Method

30. Conclusion • The use of an online teaching and charting protocol for the postpartum transition, along with online professional support, enabled women to avoid pregnancy during this challenging period. • There were only 2 unintended pregnancies per 100 women among participants who correctly utilized the protocol within the first 12 months and 8 pregnancies per 100 women including those who used the protocol incorrectly. • Acceptability and ease of use of the online system was encouraging but enhancements to the website and protocol modifications should further improve acceptability of the method.

31. The End • Accepted for publication: • Bouchard, T, Schneider, M & Fehring, R. "Efficacy of a New Postpartum Transition Protocol for Avoiding Pregnancy“ Journal of the American Board of Family Medicine.