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TRANSCRIPT
All-‐natural, hormone-‐free birth control?
An inves6ga6on of Fer6lity Awareness-‐Based Methods
Marie Tillema Murray, PharmD PGY1 Community Pharmacy Resident
H-‐E-‐B Pharmacy and The University of Texas at AusDn January 13, 2017
Learning objecDves
• Review contracepDve methods and their relaDve use and efficacies.
• Describe various FerDlity Awareness-‐Based Methods (FAM) methods.
• Analyze studies related to the efficacy of FAM.
• Discuss the advantages and disadvantages of FAM.
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PaDent case • A 29 year-‐old female paDent who was recently hospitalized for a DVT is seeking effecDve birth control. She is a smoker (½ ppd x 5 years) and was adherent to Lo LoEstrin® Fe 1/20 (ethinyl estradiol/norethindrone) before she was hospitalized. She has a history of irregular menstrual cycles (25-‐35 days). Family history includes her mother having a stroke at age 59. She is concerned about the side effects of birth control a\er her experience and does not want to use hormonal contracep6on anymore.
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Case quesDon
• The paDent has agreed to quit smoking thanks to your excellent moDvaDonal interviewing skills. She and her husband have no children and do not want to get pregnant now, but the paDent says they may want to in about a year or so.
• What can you recommend for contracepDon?
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A REVIEW OF USAGE AND EFFICACIES OF VARIOUS TYPES OF
ContracepDve methods
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Use of current contracepDve methods in the US*
*Data from 37.6 million women using contracepDon aged 15-‐44, surveyed from 2011-‐2013 6
0.8% Fertility Awareness-Based Methods
AN INTRODUCTION TO
FerDlity awareness-‐based methods
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DefiniDon
• FerDlity awareness – IdenDfying ferDle and inferDle days of the menstrual cycle on a daily basis using tracking methods (calendar-‐based or symptom-‐based)
• AKA Natural Family Planning
• CollecDon of methods – O\en grouped together in data reporDng
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Types of methods
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Calendar-‐based
• Standard Days • Rhythm Method
Symptom-‐based
• TwoDay • Basal body temperature • OvulaDon (Creighton, Billings) • Symptothermal
The menstrual cycle
• Calendar-‐based methods assume ovulaDon typically occurs around the 14th day of the menstrual cycle
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Physiological basis for symptom-‐based FAM
• Temperature – Rises slightly (0.5 – 1.1 F)
at ovulaDon • Cervical mucus
– Secreted throughout menstrual cycle with varying wetness and thickness
– InferDle: dry, non-‐lubricaDve, and/or “sDcky”
– FerDle: wet, lubricaDve, and/or “stretchy”
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Cervical mucus: a natural ferDlity valve
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Efficacy of FAM methods
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Method
Percentage of women with unintended pregnancy in first year of use
Common use Correct and consistent use
FerDlity awareness-‐based methods 24 -‐
Standard Days 12 5
Two Day 14 4
Basal body temperature 25 1
OvulaDon 2 – 22 ? 0.14 – 3
Symptothermal 2 – 8 0.4
Standard Days method
• Developed in 2001 by the InsDtute for ReproducDve Health at Georgetown University
• For women with regular menstrual cycles between 26 – 32 days
• How it works – Avoid [unprotected]
intercourse on cycle days 8 – 19
– Can use “cycle beads” to help visualize ferDle and inferDle days
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Standard Days study: Arevalo (2002)
Par6cipants
• n = 478 women aged 18-‐39 • In monogamous relaDonships, seeking to avoid pregnancy
• Bolivia, Peru, and Philippines • Self-‐reported cycles of 26 – 32 days
• Exclusion during trial: parDcipants who had cycles outside of 26 – 32 days more than twice (n=134)
Methods
• ProspecDve, non-‐randomized, mulD-‐center
• ParDcipants trained on method and given cycle beads
• ParDcipants tracked menses, intercourse, and use of other contracepDves on calendar
• ParDcipants followed for 13 cycles and interviewed at each cycle
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Results
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46% completed study
65% of pregnancies occurred in days 8 – 19 with unprotected intercourse
92% followed correct method use
Use of method Pregnancy rate per year (%) 95% CI
Correct method use 4.75 2.33 – 7.11
Backup contracepDve used during cycle days 8-‐19
5.70 3.11 – 8.16
Typical use 11.96 847 – 15.33
Two-‐Day method
• Developed in the 2000s by the InsDtute for ReproducDve Health at Georgetown University
• How it works – Woman notes daily presence or absence of cervical secre6ons and avoids intercourse following algorithm
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Two-‐Day Method study: Arevalo (2004)
Par6cipants
• n = 450 women aged 18-‐39 who had at least one prior pregnancy
• In monogamous relaDonships, seeking to avoid pregnancy
• Guatemala, Peru, and Philippines
• Exclusion during trial: ParDcipants with less than 5 or greater than 14 days of secreDons per cycle (n=29)
Methods
• ProspecDve, non-‐randomized, mulD-‐center
• ParDcipants trained on method
• ParDcipants tracked presence or absence of cervical secreDons, menses, intercourse, and use of other contracepDves on calendar
• ParDcipants followed for 13 cycles and interviewed at each cycle
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Two-‐Day Method study results
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53% completed study 75% of pregnancies occurred during unprotected or backup
method intercourse during ferDle days 94% followed correct method use
Use of method Pregnancy rate per year (%) 95% CI
Correct method use 3.5 1.44 – 5.52
Backup contracepDve used during ferDle days
6.3 3.61 – 8.81
Typical use 13.7 9.93 – 17.34
Strengths, limitaDons, and conclusions of Standard Days and TwoDay Method studies
• Strengths – Large, diverse sample sizes – Most pregnancies occurred during Dmes idenDfied by methods as
ferDle – >90% of parDcipants followed correct method use
• LimitaDons – Used self-‐reported data from parDcipants – Significant number of parDcipants excluded because they had cycles
outside of 26 – 32 days (Standard Days) – Non-‐randomized – User error with methods à unintended pregnancies
• Conclusions – Both studies demonstrate efficacy of respecDve methods in avoiding
pregnancy when methods are used correctly, but data is second-‐hand (from parDcipants)
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OvulaDon methods
• Developed in the 1960s – 70s • Billings, Creighton, others • How it works
– Woman checks and records characterisDcs of cervical mucus daily to determine ferDle days
• Dryness or wetness • Color (clear, cloudy, white, etc.) • Consistency (tacky, sDcky, stretchy)
– Unprotected intercourse is avoided on ferDle days
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Creighton Model studies overview
• ParDcipants arended 9 one-‐on-‐one teaching sessions with trained Creighton Model teachers (data collected starDng a\er first session)
• Incidence and inten6onality of pregnancies monitored for 12 – 18 months
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Creighton Model studies results
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Study (year) Par6cipants, n
Percentage of par6cipants with unintended pregnancy per year (%)
Method use* Typical use*
Fehring (1994) 242 1.2 2.0
Howard and Stanford (1999) 701 0.14 Not specifically
reported
Hilgers (1998) Meta-‐analysis 1,876 0.5 3.2
*Confidence intervals, other staDsDcs not reported
Strengths, limitaDons, and conclusions
• Strengths – Standardized methods in teaching and tracking method – Large sample sizes – ProspecDve
• LimitaDons – Studies included women who wanted to avoid OR achieve pregnancy – DefiniDon of unintended pregnancy – Self-‐reported data – Non-‐diverse populaDon (mostly white, well-‐educated, married,
Catholic) – StaDsDcal analysis?
• Conclusions – Studies demonstrated efficacy of methods when correctly used to
avoid pregnancy, but data is difficult to generalize because of paDent populaDon (seeking to achieve and avoid pregnancy, demographics)
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Symptothermal method
• CombinaDon of basal body temperature method and ovulaDon methods
• How it works – Monitor and track on a daily basis:
• Basal body temperature
• Cervical mucus
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Symptothermal method study: Frank-‐Hermann (2007)
Par6cipants
• n = 900, women aged 19-‐45 seeking to avoid pregnancy
• Germany
• Exclusion criteria: cycle > 35 days
Methods
• ProspecDve, longitudinal (1985-‐2005), non-‐randomized
• ParDcipants trained on method
• ParDcipants tracked basal body temperature, cervical mucus observaDons, intercourse, and family planning inten6on
• Charts sent to study center • ParDcipants monitored for 12 months
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Results
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Results
Strengths, limitaDons, and conclusions
• Strengths – Large sample size – More staDsDcal analysis than previous studies
• No significant difference found between those who were correct method use and those who used barrier methods during ferDle days
– Analyzed pregnancy rates according to sexual behavior • LimitaDons
– Self-‐reported data – Changes in sexual behavior over Dme (1985-‐2005)?
• Conclusions – Demonstrated efficacy of method with correct use (and protected intercourse during ferDle Dme)
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Standard Days 5% correct use
Standard Days 6-‐12% typical use
Two-‐Day 4% correct use
Two-‐Day 6-‐14% typical use
OvulaDon methods 0.14-‐3% correct use
OvulaDon methods 2-‐22% typical use
Symptothermal 0.4% correct use
Symptothermal 2-‐8% typical use
FAM studies: overall criDque
• Large and overall diverse sample sizes • ProspecDve, observaDonal • Rely on parDcipants’ charDng for data • LimitaDons on calculaDng effecDveness in Creighton Model
• More studies needed
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FAM in OTC aisles
• Thermometers – No special thermometer needed – Needs to read to tenth place
• OvulaDon Kits – More appropriate for achieving
pregnancy rather than avoiding it – IdenDfy the LH surge up to 24 to
48 hours before ovulaDon – Sperm can survive 3 to 5 days so
if woman has intercourse before detecDng the LH surge, the egg could sDll be ferDlized
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Is there an app for that?
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iCycleBeads 2Day Method
NFP CharDng
Creighton NFP CharDng
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WEIGHING THE BALANCE Advantages and disadvantages of FAM
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Advantages of FAM
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Empowers woman to understand her body
and her ferDlity
Adheres to some religious and cultural
values No side effects
Minimal to no cost CooperaDon of partner
Some methods may have comparable
efficacy to hormonal contracepDves
Can be used to idenDfy ferDlity
problems or other health concerns
Disadvantages of FAM
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Some methods may not be appropriate for women with cycles outside of 26-‐32 days
EducaDon and training may be
necessary
Requires consistent and accurate monitoring and
recording
Requires absDnence or alternaDve form of contracepDon on
ferDle days
Lack of cooperaDon of partner
Efficacy not well-‐established: more studies are needed
Lack of provider awareness and/or understanding
RETURNING TO OUR CASE QUESTION
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Case quesDon recap • 29 year-‐old female paDent • Recently hospitalized for a DVT • Previously adherent on Lo LoEstrin® Fe 1/20 • History of irregular menstrual cycles, running from 25 to 35 days
• Family history – mom had stroke at age 59 • Going to stop smoking • May want to get pregnant in a year or so • Does not want to use hormonal contracepDon anymore
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What would you recommend?
A. Standard Days method B. TwoDay method C. OvulaDon method D. Symptothermal method E. Other non-‐hormonal method (diaphragm,
condom, etc.)
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Thank you
• Dr. Nathan Pope • Dr. Mark Comfort and all residency preceptors • Drs. Angelica Cuenco, Gretchen Dao, Mikaela DeBarba, and Ashley Floyd
• Dr. Jeremy Kalamarides and Heather Kalamarides
• Marcia Kiger
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QuesDons
References
1. Daniels K, Daugherty J, Jones J. Current contracepDve status among women aged 15–44: United States, 2011–2013. NCHS data brief, no 173. Hyarsville, MD: NaDonal Center for Health StaDsDcs. 2014.
2. World Health OrganizaDon (WHO) Department of ReproducDve Health and Research, Johns Hopkins Bloomberg School of Public Health/Center for CommunicaDon Programs (CCP). Knowledge for health project. Family planning: a global handbook for providers (2011 update). BalDmore, MD; Geneva, Switzerland: CCP and WHO; 2011; and Trussell J. ContracepDve failure in the United States. ContracepDon 2011;83:397–404.
3. Hilgers TW, Abraham GE, Cavanagh D. Natural family planning. I. The peak symptom and esDmated Dme of ovulaDon. Obstet Gynecol. 1978;52(5):575-‐82.
4. Hilgers, T.W., Daly, K.D., Prebil, A.M. et al. The Picture DicDonary of the CREIGHTON MODEL FerDlityCareTM System, Pope Paul VI InsDtute Press, Omaha, Nebraska, 2001
5. Thijssen A, Meier A, Panis K, Ombelet W. 'FerDlity Awareness-‐Based Methods' and subferDlity: a systemaDc review. Facts Views Vis Obgyn. 2014;6(3):113-‐23.
6. Family planning: a global handbook for providers: 2011 update. World Health OrganizaDon, Johns Hopkins Bloomberg School of Public Health, United States Agency for InternaDonal Development; 2011.
7. Trussell J. ContracepDve failure in the United States. ContracepDon. 2011;83(5):397-‐404. 8. World Health OrganizaDon. Family planning/ContracepDon Fact sheet. hrp://who.int/mediacentre/
factsheets/fs351/en/. Updated December 2016. Accessed December 2016.
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References 9. Arévalo M, Jennings V, Sinai I. Efficacy of a new method of family planning: the Standard Days Method. ContracepDon.
2002;65(5):333-‐8. 10. Arévalo M, Jennings V, Nikula M, Sinai I. Efficacy of the new TwoDay Method of family planning. FerDl Steril. 2004;82(4):
885-‐92. 11. Trussell J, Grummer-‐Strawn L. ContracepDve failure of the ovulaDon method of periodic absDnence. Fam Plann Perspect.
1990;22:65–75. 12. Fehring RJ, Lawrence D, Philpot C. Use effecDveness of the Creighton model ovulaDon method of natural family planning. J
Obstet Gynecol Neonatal Nurs. 1994;23(4):303-‐9. 13. Howard MP, Stanford JB. Pregnancy probabiliDes during use of the Creighton Model FerDlity Care System. Arch Fam Med.
1999;8(5):391-‐402. 14. Hilgers TW, Stanford JB. Creighton Model NaProEducaDon Technology for avoiding pregnancy. Use effecDveness. J Reprod
Med. 1998;43(6):495-‐502. 15. Hilgers TW, Stanford JB. Creighton Model NaProEducaDon Technology for avoiding pregnancy. Use effecDveness. J Reprod
Med. 1998;43(6):495-‐502. 16. Frank-‐herrmann P, Heil J, Gnoth C, et al. The effecDveness of a ferDlity awareness based method to avoid pregnancy in
relaDon to a couple's sexual behaviour during the ferDle Dme: a prospecDve longitudinal study. Hum Reprod. 2007;22(5):1310-‐9.
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