"Fertility awareness-based methods" (FAB) of family planning "involve identification of the fertile days of the menstrual cycle, whether by observing fertility signs such as cervical secretions and basal body temperature, or by monitoring cycle days. FAB methods can be used in combination with abstinence or barrier methods during the fertile time" (WHO 2000). Several names have been used to describe this approach to contraception, including "rhythm," "natural family planning" and "periodic abstinence." Fertility awareness-based methods can be used with abstinence from sexual intercourse. Alternatively, they can be used with barrier contraceptives or withdrawal during presumed fertile times.
Objectives
We retrieved and analyzed all randomized controlled trials that examined any fertility awareness-based methods used for contraception.
Search Strategy
We searched the computerized databases Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, POPLINE, EMBASE, and LILACS (each from its inception to January, 2004) for randomized controlled trials of fertility awareness-based methods. We examined the reference list of each trial as well as that of review articles.
Selection Criteria
We included all randomized controlled trials in any language that compared any fertility awareness-based methods for contraception with a placebo; another method, including an alternative fertility awareness-based method; or fertility awareness-based methods used in conjunction with another contraceptive.
Data Collection and Analysis
We assessed all titles and abstracts found for inclusion. We evaluated the methodological quality of the trials for potential biases by qualitatively assessing the study design; randomization method; allocation concealment; blinding; premature discontinuation rates; and loss to follow-up rates. Because of methodological weaknesses, we could not enter the trial results in RevMan, calculate measures of association, or aggregate data.
Main Results
Because of poor methods and reporting, pregnancy rates could not be determined. A trial in Colombia found similar numbers of pregnancies among women randomized to the ovulation and symptothermal methods. In contrast, a companion trial in Los Angeles observed more pregnancies in the group assigned to the ovulation method. In the two U.S. trials, recruitment of participants was unexpectedly difficult; this aspect was not mentioned in the report from Colombia. Continuation rates were poor. In the two larger trials, most participants discontinued their assigned method before entering the observation phase of the trial. REVIEWERS'
Conclusions
The comparative efficacy of fertility awareness-based methods of contraception remains unknown. Despite intensive training and ongoing support, most participants in these trials discontinued prematurely. Contraceptive methods should be properly evaluated, preferably in randomized controlled trials, before adoption and dissemination.
fertility awareness-based methods, natural family planning efficacy, FAB contraception, cervical secretion monitoring, basal body temperature method, symptothermal method, calendar-based methods, Cochrane review fertility awareness, periodic abstinence contraception, ovulation detection methods
PMID 15495128 15495128 DOI 10.1002/14651858.CD004860.pub2 10.1002/14651858.CD004860.pub2 Grimes et al. 2004, Grimes 2004
Cite this article
Grimes, D. A., Gallo, M. F., Grigorieva, V., Nanda, K., & Schulz, K. F. (2004). Fertility awareness-based methods for contraception. The Cochrane database of systematic reviews, 2004(4), CD004860. https://doi.org/10.1002/14651858.CD004860.pub2
Grimes, D. A., et al. "Fertility awareness-based methods for contraception." The Cochrane database of systematic reviews, vol. 2004, no. 4, 2004, pp. CD004860.
Background and PurposePublished reports indicate that over 100 million women worldwide use the birth control pill (Oral Contraceptives, or OCPs).1,2 However, in a national study conducted by the Battelle Centers for Public Health Research and Evaluation, rates of discontinuation of some birth control methods were as high as 90%, and had averages between 40-61% (depending on marital status) for women who were followed over a two-year period.3 This suggests that women are searching for new methods, perhaps with fewer side effects or better effectiveness rates. Studies show up to 60% of women would be interested in using Fertility Awareness Based Methods (FABMs) if given information.4 Both FABMs and OCPs entail behavior modification on a daily basis, so the efficacy and side effects of FABMs and OCPs were chosen for comparison during this study.Most commonly reported unintended pregnancy rates for FABMs and OCPs are based on low quality retrospective surveys. A popularly cited review from J. R. Trussell and colleagues reports typical use failure rates of 24% for FABMs and 9% for OCPs.5 These numbers are based on estimates of the probability of pregnancy drawn from the 1995 and 2002 National Surveys of Family Growth.5'6 There are at least three major problems with these surveys. One is that these are lower quality retrospective surveys based primarily on patient recall, with the data collected via a series of phone surveys. Another major problem is that 86% of the purported FABM users surveyed identified the calendar method-a much older and less effective method-as their primary form of contraception. Then, the rates for all types of FABMs were pooled together, including some methods which are not even classified as FABMs by trained providers. This lumping together of all FABMs including rhythm masks important differences in effectiveness among the variety of modern methods; a fact acknowledged by Trussell, the author of this estimate.7'8'9 The third major issue with this review is that the rates of effectiveness were adjusted to account for the researchers' assumption of underreporting of abortion. As a result of the issues with these popularly cited statistics, we sought to design objective criteria with which to evaluate the primary literature available for FABMs and OCPs, in order to understand both the quality of the studies available as well as the true effectiveness rates. In total, three major search engines (Medline, PubMed, and EMBASE) were used with keyword searches to identify relevant articles. For FABMs, 30 articles from 1980 on were included in the study.6 For OCPs, 47 articles from 2000 on were included in the study. (The year 2000 was chosen in part because studies from earlier decades had used higher dose hormone formulations which were proven to be unsafe for women, and the trend in later years has been towards seeking lower dose hormonal formulations to provide the same efficacy with fewer side effects1). Strength of Recommendation Taxonomy (SORT) criteria10 were established first for the FABM review6 and then adapted for the OCP review (Adapted SORT). The adaptation was based on fundamental differences between FABMs and OCPs such as lack of a learning phase for OCPs. The purpose of the SORT and Adapted SORT criteria was to provide a framework to determine the level of evidence for individual studies.Two independent reviewers scored each of the identified articles for the FABMs and the OCPs reviewed. Major discrepancies in scores were resolved by sending the articles in question to a third reviewer for a tie-break score. For the FABMs reviewed, there were 56 maximum possible points with the SORT criteria. The scores ranged from 31-55 points, and 10 of the 30 articles (30%) were found to earn a SORT Level 1 status (qualified by earning a positive score in all of the critical criteria).6For the OCPs reviewed, there were 42 maximum possible points with the Adapted SORT criteria. …
fertility-awareness/effectiveness/comparative-effectivenesscontraception/comparative-studies/contraception-versus-fertility-awareness
Open Access
The aim was to compare the efficacy and acceptability of two Internet-supported fertility-awareness-based methods of family planning. Six hundred and sixty-seven women and their male partners were randomized into either an electronic hormonal fertility monitor (EHFM) group or a cervical mucus monitoring (CMM) group. Both groups utilized a Web site with instructions, charts and support. Acceptability was assessed online at 1, 3 and 6 months. Pregnancy rates were determined by survival analysis. The EHFM participants (N=197) had a total pregnancy rate of 7 per 100 users over 12 months of use compared with 18.5 for the CMM group (N=164). The log rank survival test showed a significant difference (p<.01) in survival functions. Mean acceptability for both groups increased significantly over time (p<.0001). Continuation rates at 12 months were 40.6% for the monitor group and 36.6% for the mucus group. In comparison with the CMM, the EHFM method of family planning was more effective. All users had an increase in acceptability over time. Results are tempered by the high dropout rate.
Introducing a new method into family planning programs requires careful attention to ensure it meets an actual need and has a positive effect on program goals. The Standard Days Method® is a fertility awareness-based method of family planning that is being introduced into family planning programs in countries around the world. It is different from other methods offered by programs, and may bring new couples into family planning, and increase contraceptive prevalence. The study assesses the effect on contraceptive use and prevalence of Introducing Standard Days Method into existing family planning services in whole regions of India, Peru, and Rwanda. In collaboration with the Ministry of Health, health providers were given a contraceptive update on all methods, then trained in counseling on Standard Days Method. Efforts were made to promote demand in the context of informed choice. Routine monthly service statistics in control and intervention areas were used to assess the effect of Standard Days Method introduction at the clinic level; baseline and endline household-based surveys were undertaken to obtain results at the community level (n > 3400 women at endline). Demand for the method is evident in countries with different levels of contraceptive prevalence. The method attracts couples new to family planning, and introducing it into services may increase overall contraceptive prevalence. Introducing Standard Days Method into existing family planning has the potential of benefiting men and women in diverse settings and populations. This study illustrates the critical role of evidence in scaling up a health innovation.
To determine if an electronic hormonal fertility monitor aided method (EHFM) of family planning is more effective than a cervical mucus only method (CMM) in helping couples to avoid pregnancy. Six hundred twenty-eight women were taught how to avoid pregnancy with either the EHFM (n=313) or the CMM (n = 315). Both methods involved standardized group teaching and individual follow-up. All pregnancies were reviewed and classified by health professionals. Correct use and total unintended pregnancy rates over 12 months of use were determined by survival analysis. Comparisons of unintended pregnancies between the 2 methods were made by use of the Fisher exact test. There were a total of 28 unintended pregnancies with the EFHM and 41 with the CMM. The 12-month correct use pregnancy rate of the monitor-aided method was 2.0%, and the total pregnancy rate was 12.0%. In comparison, the 12-month correct use pregnancy rate of the CMM was 3.0%, and the total pregnancy rate was 23.0%. There was a significant difference in total pregnancies between the 2 groups (p<0.05). EFHM is more effective than CMM. Further research is needed to verify the results.