J Am Board Fam Med: first published as 10.3122/jabfm.2013.01.120126 on 2 January 2013. Downloaded from ORIGINAL RESEARCH Efficacy of a New Postpartum Transition Protocol for Avoiding Pregnancy Thomas Bouchard, BSc, MD, Richard J. Fehring, PhD, RN, FAAN, and Mary Schneider, MSN, APRN 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 of- ten occurs before first menses. For this reason, a protocol was developed to assist women in identifying their return of fertility postpartum to avoid pregnancy. Methods: In this prospective, 12-month, longitudinal cohort study, 198 postpartum women aged 20 to 45 years (mean age, 30.2 years) were taught a protocol for avoiding pregnancy with either online or in-person instruction. A hand-held fertility monitor was used to identify the fertile period by testing for urinary changes in estrogen and luteinizing hormone, and the results were tracked on a web site. Dur- ing lactational amenorrhea, urine testing was done in 20-day intervals. When menses returned, the monitor was reset at the onset of each new menstrual cycle. Participants were instructed to avoid inter- course during the identified fertile period. Kaplan-Meier survival analysis was used to calculate unin- tentional pregnancy rates through the first 12 months postpartum. Results: There were 8 unintended pregnancies per 100 women at 12 months postpartum. With cor- rect use, there were 2 unintended pregnancies per 100 women at 12 months. Conclusion: The online postpartum protocol may effectively assist a select group of women in avoid- ing pregnancy during the transition to regular menstrual cycles. (J Am Board Fam Med 2012;26: 35–44.) Keywords: Breast Feeding, Lactation, Natural Family Planning Methods, Ovulation Detection, Postpartum Period The breastfeeding transition (from amenorrhea to cycles postpartum.1 In nonlactating women, ovula- regular menstrual cycles) is one of the most chal- tion can occur as early as 25 days postpartum but http://www.jabfm.org/ lenging situations for women wishing to use natural usually occurs between 45 to 94 days postpartum, family planning (NFP) to avoid pregnancy. This is and ovulation leading to sustained pregnancy usu- because of the variability in the length of postpar- ally occurs at 42 days or later.2 However, in lactat- tum lactational amenorrhea, the uncertainty of ing women, ovulation is significantly delayed: only whether ovulation will occur before the first men- 20% will have ovulated by 6 months and only 64% ses, and the irregularities in the first menstrual ovulate by 12 months, with a mean of 322 days of anovulation.3 There is reduced fertility while not in on 1 October 2021 by guest. Protected copyright. cycles even when ovulation returns, and although This article was externally peer reviewed. two thirds of women ovulate before their first men- Submitted 16 May 2012; revised 9 August 2012; accepted 13 August 2012. ses, only half of these (one third of breastfeeding From the Department of Family Medicine, University of women) have adequate pregnanediol excretion and Calgary, Calgary, Alberta, Canada (TB); the Marquette University College of Nursing Institute for Natural Family luteal phase lengths to theoretically sustain a preg- Planning, Milwaukee, WI (RJF, MS); and the Institute for nancy.4 Because it is difficult to predict which sub- Natural Family Planning (RJF). Funding: Funding for this study has been provided by the set of women will ovulate before their first menses, Marquette University College of Nursing Institute for Nat- it is important to give women tools to detect their ural Family Planning. Conflict of interest: none declared. return to fertility should they choose to use NFP to Corresponding author: Thomas Bouchard, BSc, MD, De- avoid pregnancy. partment of Family Medicine, University of Calgary, 101-83 Deerpoint Rd SE, Calgary AB Canada, T2J 6W5, Canada NFP methods use natural signs of fertility, (E-mail: [email protected]). which include observations of cervical mucus and doi: 10.3122/jabfm.2013.01.120126 A Postpartum Protocol for Avoiding Pregnancy 35 J Am Board Fam Med: first published as 10.3122/jabfm.2013.01.120126 on 2 January 2013. Downloaded from basal body temperature, to identify the fertile pe- of use,18 but it assumes that women use the lacta- riod (the alternative term fertility awareness-based tional amenorrhea method (LAM) before this. methods has been used to denote those methods that A recent Cochrane systematic review of the lit- identify the fertile phase and teach users to avoid erature about LAM suggested that there was no unprotected intercourse during the fertile phase difference in unintended pregnancy rates between but allow for use of barrier methods during this fully breastfeeding amenorrheic women and those time).5 During the breastfeeding transition, cervi- who followed the LAM rules. Pregnancy rates cal mucus changes often do not coincide with hor- ranged from 0.45 to 2.45 at 6 months of use in the monal variations6 or with ovulation as confirmed by 2 controlled studies and from 0 to 7.5 at 6 months ultrasound.7 Temperature measurements may not of use in the uncontrolled studies.19 Although the be accurate in the first cycles after the return of unintended pregnancy rate found by some studies menses,8 and integrated rules of an NFP method of the LAM that have been extended to 12 months that used mucus and temperature signs showed low is reasonable (ie, the highest being 7.4 per 100 specificity and positive predictive value but good women), these results are applicable only to those sensitivity in predicting the return of fertility.4 One women who continue to have postpartum amenor- study has suggested that breastfeeding women who rhea.20 adhered to the rules of the ovulation method (based Researchers from Marquette University have on identifying when mucus becomes fertile) after developed a new postpartum protocol (Table 1)21 menses returns may have a higher unintended that uses an electronic hormonal fertility monitor pregnancy rate than those who were not lactating.9 (EHFM; ClearBlue Easy Fertility Monitor, Swiss Pre- In addition, there is confusion among users about cision Diagnostics, Geneva, Switzerland; Figure 1) to the interpretation of the natural signs of fertility identify the fertile period. The EHFM measures during the breastfeeding transition,10 especially if changes in urinary estrone-3-glucuronide from these women have had irregular cycles previously.11 baseline and urinary luteinizing hormone (LH) In studies that have investigated the efficacy of above a specific threshold.22 Product testing has NFP during the breastfeeding transition,4,6,11–18 shown the ClearBlue monitor to be 98% accurate the pregnancy rates at 12 months have ranged from in detecting the LH surge.23 Although the EHFM 11.113,15 to 24 per 100 women.16 A more recent was originally marketed to help women identify study of a new calendar-based NFP method (the their fertile period to assist with conception, the Bridge Method), to be used once a woman has had Marquette postpartum protocol customizes the use her first menses, determined a pregnancy rate of of the monitor to identify the fertile period to avoid http://www.jabfm.org/ 11.2 per 100 women over a typical 6-month period pregnancy. During postpartum amenorrhea, Table 1. Revised Postpartum Protocol With Additional Rules Original Protocol* for Artificial Cycles During Amenorrhea Additional Rules for First 6 Cycles After the Return of Menses on 1 October 2021 by guest. Protected copyright. 1. Trigger a cycle by pushing the “M” button on the 9. When menses returns, reset the monitor and erase the memory (erase monitor. the memory for all 6 cycles postpartum). Day 1 is the first day of 2. Fast-forward the monitor to day 5. menses. Begin testing when the monitor asks for a test on day 6. 3. The monitor will ask for a test for the next 20 10. Fertility begins on day 10 of the first cycle after the return of days. menses, day 9 in the second cycle, day 8 in the third cycle, day 7 in 4. Test your first morning urine every other day. the fourth cycle, and day 6 in the fifth cycle onward. However, if the 5. When a high is recorded, test the urine every day. monitor records a high reading before these days, then fertility starts 6. Retrigger the monitor and fast-forward every 20 on the day of the first high reading. days. 11. (Optional) Beginning on day 6 of the first menstrual cycle 7. Continue steps 1–6 until you detect a peak postpartum, women may do a second test for the LH surge in the reading and resume menses. evening with a separate LH test kit. 8. To avoid pregnancy, avoid intercourse on high and peak days and 3 full days after the last peak day. This study used the rules of the original protocol, which are listed in the left column. The revised rules are in the right column. *The original protocol is taken from Ref. 21. LH, luteinizing hormone. 36 JABFM January–February 2012 Vol. 26 No. 1 http://www.jabfm.org J Am Board Fam Med: first published as 10.3122/jabfm.2013.01.120126 on 2 January 2013. Downloaded from Figure 1. ClearBlue Easy Fertility Monitor with a test demonstrated that the monitor would cut the esti- stick inserted. Three bars indicate low (1 bar), high (2 mated time of abstinence approximately in half.21 bars, based on detection of E3G rise), or peak fertility In a separate study including postpartum women (3 bars and an egg symbol, based on detection of and women with regular cycles, the same research- luteinizing hormone threshold).