Randomized Comparison of Two Internet Supported Natural Family Planning Methods

1. Randomized Comparison of Two Internet Supported Natural Family Planning Methods US Dept of Health & Human Services Office of Population Affairs NFP/FA Grantee Meeting Washington, DC January 14-15, 2009

2. Marquette Research Team • Richard Fehring, PhD, RN • Mary Schneider, MSN, FNP • Susana Crespo, BSN , RN • Mingan Yang, PhD • Teresa Roumonada, BA, RN • Kathy Raviele, MD

3. Overall Problem • Only 0.2% of US women use modern methods of natural family planning, i.e., temperature and cervical mucus methods of natural family planning (NFP) (NSFG, 2002). • Another 0.4% use calendar based or, most likely, self-devised calendar based methods. • The ever use rate of NFP methods since 1988 has remained around 2-3% • Only married couples use NFP in NSFG data set.

4. Specific Problem • Women (and men) want safe, effective, easy to use, and convenient methods of family planning.1-3 • Although NFP methods are free of side effects, they are often ineffective and complex to learn and use.4-6

5. Reasons for Lack of Use • NFP methods are often ineffective, • Difficult to use, • Lack of access to properly trained NFP teachers, • Lack of motivation to use a behavioral method, • Health professionals are reluctant to prescribe NFP methods.

6. Solving Problem Efforts have occurred over the past 10 years to: • Simplify the teaching and use of NFP methods • Increase the efficacy.3,4,7,8 • These efforts include the development of: - low tech calendar-based methods4, - simplifying instructions7,8, and - developing accurate biological markers of fertility.9-13

7. Technological Advancements • Urine LH detection • ClearBlueMonitor

8. Clearblue Easy Fertility Monitor A Hand Held Electronic Fertility Monitor Screen that indicates fertility level! Button to turn on Monitor Day of cycle “M” Button Slot to clip in test strip to be read by the monitor!

9. Clearblue Fertility Monitor • Low Fertility • High Fertility • Peak Fertility

10. Background studies • Behre et. al., (2000) accuracy of monitor • Robinson, et. al., (2007) randomized study for achieving pregnancy • Fehring, Schneider, et. al., three studies with monitor to avoid pregnancy • No randomized studies to compare electronic hormonal monitoring with other NFP methods.

11. Research On CPFM (N=53) With 135 cycles with a monitor LH surge and ultrasound confirmed ovulation: • ovulation was detected in 91.1% of cycles during the 2 days of CPFM peak • ovulation never occurred before CPFM peak fertility • serum estrogen rise correlated 92% of time with the first “high” reading on the monitor See Behre et al (2000) Human Reproduction; vol 15(12): pp2478-2482

12. Sympto-Hormonal Method Hormonal Monitoring Cervical mucus monitoring (CMM) Fertility Formula Correct use = 98 - 99% Typical use = 86 - 90% Fehring, Schneider, Barron, Raviele, Efficacy of the MM of NFP, JOGNN, 2007 Fehring, Schneider, Barron, Retrospective efficacy of MM, MCN, 2008 Fehring, Schneider, Barron, Raviele, Cohort Comparison, JRM, 2009 Pending

13. Online Provision of NFP Northwest Family Services (STM) Franciscan system California (OM) OvuSoft (STM) Marquette (Our Sunday Visitor)

14. Marquette Online NFP Information on NFP and special circumstances Focused on teaching simple electronic hormonal fertility monitoring (EHFM) and/or cervical mucus monitoring (CMM) Online charting and interpretation Discussion rooms and library Consult nurse; physician; bio-ethicist

16. Pilot Study • 50-100 participants using Web site to achieve or avoid pregnancy • Outcomes = Knowledge of fertility; Satisfaction and ease of use at 1, 3 and 6 months of use • Unintended pregnancies (automatic assessment)

17. Need for Study • Although there have been studies to determine the knowledge base of an online hormonal contraceptive program there have been no studies to determine the efficacy of internet-based instructions for NFP methods used to avoid pregnancy. • Nor have there been studies to determine the efficacy and satisfaction of using an online fertility charting system for NFP purposes.

18. Mutual Motivation • A key component in the use of NFP or any type of behavioral focused method of family planning is the motivation of both partners in the use of the method to avoid pregnancy. • If only one of the partners is committed to the method it will be difficult to use and the efficacy will most likely be lower. • Mutual motivation has been recognized in the family planning and, in particular the NFP community, as essential for NFP efficacy. • However, there have been no recent studies that have investigated this component for the use of NFP methods.

19. Mutual Motivation Model Low Unintended Pregnancies & Discontinuation Woman’s Fertility Motivation High motivation across time Easy to use FP method Acceptable FP method Accurate indicator of fertility Satisfaction with method Motivation to use method Efficacy of method 1 month, 3 months, 6 months, 9 months, 12 months Low motivation across time High Unintended Pregnancies & Discontinuation Man’s Fertility Motivation

20. Way to Increase Use of NFP • provide easy access • to an effective but simplified NFP method that • uses electronic hormonal fertility monitoring (EHFM), • an internet based charting system, • and online professional support.

21. Specific Aim - One • to determine and compare the efficacy in the use of two internet-supported methods of NFP (i.e., EHFM and CMM) in aiding couples to avoid pregnancy. • Hypothesis - Those couples who use an internet-supported EHFM-aided NFP method will have fewer unintended pregnancies over a 12-month time period compared to couples who use an internet-supported CMM-only NFP method.

22. Specific Aim - Two • to determine and compare the satisfaction and ease of use in the use of two internet-supported methods of NFP (i.e., EHFM and CMM) in aiding couples to avoid pregnancy. • Hypothesis - Those couples who use an internet-supported EHFM-aided NFP method (over a 12-month time period) will have greater satisfaction and ease of use compared to those couples who use an internet-supported CMM NFP method.

23. Specific Aim - Three • to determine and compare the mutual motivation in the use of two internet-supported methods of NFP (i.e., EHFM and CMM) in aiding couples to avoid pregnancy. • Hypothesis - There will be fewer unintended pregnancies among couples who have high mutual motivation in the use of a NFP method to avoid pregnancy (whether EHFM or CMM) compared to those couples with low mutual motivation.

24. Research Questions 1. What are the 3, 6, and 12-month correct use and total use unintended pregnancy rates of an internet-provided EHFM-aided NFP method? 2. What are the 3, 6, and 12-month correct use and total 12-month use unintended pregnancy rates of an internet-provided CMM-only NFP method? 3. What is the satisfaction, ease of use, and mutual motivation of an internet-based NFP method (either EFHM or CMM) over a 12-month time period, i.e., after 1, 3, 6, and 12 months of use?

25. Innovations 1) the use of an internet-based Web site to provide NFP instructions and support, 2) the use of an electronic fertility charting system; 3) the use of a new simplified method of NFP that utilizes EHFM, 4) the randomized comparison of two methods of NFP, i.e., EHFM and CMM, and 5) the determination of mutual motivation on NFP efficacy.

26. Methods

27. Design • This will be a 12-month (13 cycles) prospective randomized clinical efficacy trial of the EHFM plus fertility algorithm method of NFP in comparison with the CMM plus algorithm method of NFP. • A minimum of 600 couples seeking to avoid pregnancy with a method of NFP and who have no known infertility problems will be sought through an online NFP web site and randomized into either a EHFM group (N=300) or a CMM only group (N=300).

28. Female - Sample • be between the age of 18 and 42 • be in a sexually active committed relationship with a man • have a menstrual cycle range of 21-42 days • have not used Depo (injectable) contraception for the past 6 months • have not used oral or patch hormonal contraception for the past 3 months • have not breast-fed baby for at least three months • have no known fertility problems • not be using medications that interfere with fertility • not smoke cigarettes; and • not be pregnant.

29. Male Partner Sample • have no known fertility problems, and • be between the ages of 18 and 50 • be in a sexually active committed relationship with his lone woman partner.

30. Phased Recruitment • Develop advertisement and recruitment letter • Develop mailing list of Title X family planning providers and regional coordinators • Develop Marquette Web site that explains the study and how to participate • Send out e-mail advertisement to Diocesan NFP providers • Send out e-mail advertisement to NFP only health professionals • Send out e-mail advertisement to NFP list serve • Send out advertisement letter and e-mail to Title X providers • Periodically send our reminder advertisement to NFP list serve, Diocesan NFP coordinators, Title X Family Planning providers, and NFP only health professionals Note: we have over 120 couples on current NFP Web site (in less than 10 months) with little advertisement.

31. The Marquette Online Methods • At Marquette University we developed what we call the Marquette Light method of NFP that can be taught initially in a 12-minute office session. • The method uses either cervical mucus or an EHFM and a calendar-based formula as a double check for the beginning and end of the fertile phase. • Whether the woman user observes cervical mucus or uses the CEFM, she rates her fertility as being low, high, or peak, and utilizes the same fertility calendar-based formula for a double check. This simplified method needs to be evaluated for its efficacy.

32. Cervical Mucus Monitoring End of fertile window Beginning of fertile window Peak in Fertility LOW HIGH PEAK HIGH

33. Study Procedure • Online 12 minute intro slide show • Online consent • Automatically randomized • Send monitor • Online charting • Automatic reminder to complete measures, 1, 3, 6, 12 months • Online pregnancy evaluation

36. High Tech – 12 Minute Rhythm • Avoid intercourse and genital contact on all “high and peak” days!

37. High Tech Rhythm - Algorithm Fertility Begins: • On day 6 of the first 6 cycles After 6 cycles: • On first Peak day of last 6 cycles minus 6 days

38. High Tech Rhythm - Algorithm Fertility Ends: • On the last Peak day plus 3 days (or) After 6 cycles: • The Last Peak day of the last 6 cycles plus 3 days • Whatever comes first!

39. Outcomes • The participants (the women and their male partner) will be assessed at 1, 3, 6 and 12 months of use as to their satisfaction and ease of use of their respective NFP method. • They (i.e., the woman and her partner) will be asked before each menstrual cycle to rate their motivation in avoiding pregnancy up to 13 cycles of use. • Correct use and total unintended pregnancy rates will be determined at 3, 6, and 12 months

40. Measures • 10 item satisfaction and ease of use – modified from Severy • 1 item satisfaction rating • 2 item mutual motivation rating • Online pregnancy evaluation tool (modified from Kambic and Gray)

41. Mutual Motivation Female: How hard are you currently trying not to get pregnant? on a scale of 0 – 10 with 0 means you are trying hard to get pregnant and 10 means you are trying hard not to get pregnant. Please circle (or click on) your response: 0 – 1 – 2 – 3 – 4 – 5 – 6 – 7 – 8 – 9 – 10 How much do you want to avoid pregnancy at this time? on a scale of 0 – 10 with 0 means you want to get pregnant and 10 means you want to avoid pregnancy. Please circle (or click on) your response: 0 – 1 – 2 – 3 – 4 – 5 – 6 – 7 – 8 – 9 – 10

42. Satisfaction – Ease of Use • Satisfaction in the of use of the online NFP Web site will be measured by asking the woman participant and her male partner at one month, 3, 6, and 12 months of use their satisfaction of the methods on a scale of 1 = not satisfied, 2 = somewhat satisfied, 3= satisfied and 4 = very satisfied. • They will also be asked to respond to a 10 item questionnaire on whether the online Web site was acceptable, easy to use, non-invasive, a convenient in-home test of fertility, and provides clear and objective results.

43. Ease of Use Items • Including your NFP method in your daily routine. • Using the NFP method charting system. • Understanding the information the NFP method provides. • What would you say is your overall opinion of your NFP method? • To what extent, if at all, do you think using this NFP method has increased your ability to avoid pregnancy? • To what degree, if at all, do you think using the NFP method has decreased your anxiety about becoming pregnant? • How easy was it for you to use this NFP method? • At this point in time, how do you like this NFP method? • Compared to other methods that you have used to avoid pregnancy, how much of an improvement is this NFP method? • Now that you are using this NFP method, what do you guess are your chances of avoiding pregnancy next month?

44. Analysis • Correct use and total unintended pregnancy rates will be determined at 3, 6, and 12 months by use of survival analysis for the EHFM and CMM NFP methods. • The differences in unintended pregnancy rates between the two NFP methods and between high and low motivated couples will be determined by use of the Fischer exact test with a significance level of 0.05. • Repeated measure ANOVA. • Menstrual cycle parameters.

45. Limitations of Study • only healthy young women with fairly regular menstrual cycles • the participants will have to have internet access & be familiar with computers. • actual pregnancy rates will probably be lower than experienced in “real” life situations since the subject participation rewards will act as a motivation to comply with avoiding pregnancy and abstaining from intercourse during the fertile phase of the cycle. • the unintended pregnancy rates will rely on the honesty of the couples reporting the time of intercourse and genital contact. • there is a tendency to underreport genital contact and withdrawal with use of NFP methods. • Finally, since both groups of couples will be exposed to the NFP system that the other group will be using (in advertisements, consent forms, and at the introductory session) they might have some bias that the other method of NFP is better or worse.

46. Conclusion • Results of this proposed study will help women and couples in NFP decision making, the results will also help health professionals understand the efficacy of these methods and the importance of mutual motivation in their success. • Help understand the usefulness and satisfaction with online NFP services.

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