Standard Days Method Slide 1 The Standard Days Method is a new family planning method. It was developed and tested by researchers at the Institute for Reproductive Health at Georgetown University. The Standard Days Method meets the need for a natural method that can be integrated easily into public and private reproductive health programs. Slide 2 The Standard Days Method has four characteristics that make it appropriate for this purpose: * It is natural -- it does not have any side effects, it does not require any medications or surgical procedures * It is simple -- easy to teach, to learn, and to use * It is very low cost * It is effective -- when used correctly, it significantly reduces the probability of unplanned pregnancy. Slide 3 By the end of this tutorial, you will: * Understand how the Standard Days Method works * Know the biological basis of the method and how it was developed * Understand how to use the method * Know the contraceptive effectiveness of the method and basic information about the clinical trial that demonstrated this effectiveness * Begin to assess how the method can contribute to the improvement of services in your institution or program, and how to incorporate it into your services Slide 4 Let's begin with what is the Standard Days Method and how does it work. The Standard Days Method identifies days 8 -- 19 of the menstrual cycle as the fertile days, when there is a significant probability of pregnancy. On all the other days of the cycle, pregnancy is most unlikely. The method works best for women who have cycles between 26 and 32 days long. Therefore, to use the Standard Days Method to prevent pregnancy, couples avoid unprotected intercourse from day 8 through day 19 of each cycle. On all the other cycle days, they can have unprotected intercourse. To help them keep track of the woman's cycle days, and to know which days she can get pregnant, many couples use a simple visual aid- CycleBeads(tm). Slide 5 Many couples who use the Standard Days Method prefer not to have intercourse on the woman's fertile days -- days 8 through 19. Other couples prefer to use: * Condoms * Other barrier methods * Other sexual practices * Or withdrawal. On all the other days of the cycle, including during menstruation, the probability of pregnancy is so small that these days are considered not fertile, and the couple can have unprotected intercourse. It is important for people using this method to be aware that some of the alternatives for the fertile days offer more protection from pregnancy than others. On the other hand, service providers should recognize that people have different preferences and that some alternatives are more acceptable than others. Correct use and continuation depend in large part on acceptability. Slide 6 Many couples who use the Standard Days Method have found that a visual aid called CycleBeads is very useful for learning and using the method correctly. CycleBeads can help the woman: * Know which day of the cycle she is on, * Know when she is on a day when she should avoid unprotected intercourse, * Know whether her cycles are the appropriate length to keep using the method. CycleBeads are a string of color-coded beads that represent a woman's menstrual cycle. Each bead is a day of the cycle. The RED bead represents the first day of the cycle. The BROWN beads represent days when pregnancy is most unlikely. And the WHITE beads represent the fertile days, when pregnancy is very likely. How do you use Cycle Beads? CycleBeads have a moveable rubber ring to mark the days. The day your period starts, put the ring on the red bead, and mark the day in a calendar, so if you later forget to move the ring, you will know the day your cycle started. Each day, move the ring to the next bead, always in the direction of the arrow. When the ring is on a BROWN bead, pregnancy is most unlikely. This is a day when you can have intercourse. When the ring is on any of the WHITE beads, you and your partner need to avoid unprotected intercourse to prevent a pregnancy. As soon as you start your next period, move the ring to the RED bead to begin a new cycle. Remember CycleBeads work best for women who have most cycles between 26 and 32 days long. And CycleBeads can help you know if your cycles are within this range. If your next period starts before you put the ring on the darker brown bead, you will know that your cycle is too short to use CycleBeads. If your period has not started by the day after you put the ring on the last brown bead, you will know that your cycle is too long to use Cycle Beads. Slide 7 Does the Standard Days Method address the unmet need for family planning? Throughout the world, there is an enormous demand for natural methods; 8% of all women in union report that they use a traditional method. Of these, most are practicing some type of periodic abstinence. However, the vast majority of these couples who are using periodic abstinence really do not know which are the days when the woman is at risk of pregnancy. They abstain based on incorrect or incomplete information, obtained from unreliable sources. As a result, they have intercourse on some of the woman's fertile days, which logically results in pregnancy. Statistics also show us that millions of couples are not using any method of family planning. This includes many who do not want a pregnancy. Some or many of them may be interested in a simple natural method. We also know that many current users of other methods are not satisfied with their method, and that eventually they will stop using it and not begin another method. Some or many of them may want a natural method. And of course, it is important to offer a method that does not require expensive commodities, that can be provided by clinics and at the community level -- and that makes family planning a shared responsibility for both members of the couple. Slide 8 Now, let's consider the biological basis of the Standard Days Method. How was the formula 8 through 19 determined for the Standard Days Method? The formula was developed by combining various data bases related to probability: the probability of pregnancy on different days around ovulation, and the probability of ovulation on different days of the cycle. Data on the probability of pregnancy on different days around ovulation indicates that: * There is approximately a 4% probability of pregnancy from intercourse 5 days before ovulation. * This increases to 15%, 4 days before ovulation. * The highest probability of pregnancy -- between 25 and 28% -- is on the 2 days before ovulation. * On the day of ovulation, there is an 8-10% probability. * Fertility then decreases -- with a 0% probability of pregnancy by the day after ovulation. These probabilities are due to the limited viable life span of the sperm after ejaculation (not more than 5 days) and to the very limited viable life span of the egg following ovulation (less than 24 hours). Together, this results in an actual fertile window of no more than 6 or 7 days during the woman's cycle. On all the other days, the woman cannot become pregnant. But how do we know the moment ovulation occurs, and thus know the exact fertile window? Slide 9 Again, consider probabilities. Data on when during the cycle ovulation occurs indicates that in the great majority of cycles, ovulation occurs very close to the middle of the cycle. * In approximately 30% of cycles, ovulation occurs AT the mid point (for example, on or very close to day 14 in a 28 day cycle, or day 15 in a 30 day cycle). * In approximately 60% of cycles, ovulation occurs within 1 day before or after mid cycle. * And in approximately 78% of cycles, ovulation occurs within 2 days before or after the mid point -- and so on. Slide 10 With a combination of these probabilities -- the probability of pregnancy on different cycle days related to ovulation, and the probability of the timing of ovulation -- it was possible to identify the days when pregnancy is VERY LIKELY and the days when it is MOST UNLIKELY. In menstrual cycles between 26 and 32 days long (which accounts for approximately 80% of all cycles), the days pregnancy is very likely are days 8 through 19. On all the other days, pregnancy is very unlikely. Thus, researchers found that, in theory, the Standard Days Method was a very effective method of family planning. Slide 11 Then, they examined the effectiveness through a clinical study. An international multi-center study was conducted. The Standard Days Method was provided to clients of public and private sector family planning programs. * Health personnel were trained to offer the Standard Days Method to their clients. * Clients who were interested in using the method were screened according to specific criteria * They were taught how to use the method. * They were followed every month for a little over one year, to collect data about their menstrual regularity, their use of the method, their satisfaction with the method, etc. Slide 12 The effectiveness study took place in 5 sites in 3 countries. Thus, the sample size was large enough and varied enough to draw useful conclusions about effectiveness. A total of 478 couples from urban, peri-urban, semi-rural, and rural areas, and of diverse ethnic and social groups, participated in the study. Almost all the health providers were auxiliary or technical personnel. Slide 13 First, it was important to determine if couples were able to use the Standard Days Method. The 478 participating couples used the Standard Days Method for a total of 4035 cycles. In almost all cycles (96.9%), they used the method correctly. That is, they did not have unprotected intercourse on days 8 through 19. This confirmed that: * It is feasible to teach the Standard Days Method through personnel of health programs, and to do so in one relatively brief visit. * Clients can use this method correctly. * It is possible to have the help and collaboration of men to use this method. Slide 14 Of the 478 couples who used the method for a total of 4035 cycles, 43 women became pregnant. All the pregnancies were verified by hormonal pregnancy tests, on approximately day 42 of the cycle. Slide 15 The pregnancy rates are as follows: Considering all the pregnancies that occurred in cycles in which the woman reported that she did NOT have intercourse during days 8 through 19, the 1-year pregnancy rate was 4.7 pregnancies per 100 woman years of method use. This is considered the correct-use pregnancy rate. Considering all these pregnancies, plus the pregnancies that occurred in cycles in which the woman had intercourse during days 8 through 19 but used another method (such as condoms or withdrawal), the 1-year pregnancy rate was 5.6 pregnancies per 100 woman years of method use. This reflects the failure of the Standard Days Method, plus the failure of the additional method. Considering all pregnancies, including those that occurred in cycles in which the woman had unprotected intercourse on day 8 through 19 (that is, both correct and incorrect use of the method), the 1-year pregnancy rate was 11.9 pregnancies per 100 woman years of method use. This reflects that when women have unprotected intercourse during days 8 through 19, they are very likely to become pregnant. All these rates were calculated using single decrement life table analysis, with multiple exclusion. Results of the study were published in the May 2002 issue of the medical journal "Contraception". Slide 16 If these rates are compared with the failure rates of other methods that also rely on the user, we can see that the Standard Days Method has a similar effectiveness as a number of other methods (for example, condoms) and that it is more effective than some methods currently available in family planning programs (such as spermicides). The studies on which these rates are based are not necessarily comparable with each other, because of differences in their design and the methodology for data analysis. However, this gives us a general idea how the effectiveness of different methods compare. Slide 17 During the efficacy study and in subsequent pilot projects in many countries, several valuable lessons have been learned. We have learned or confirmed several important things about the Standard Days Method: * There are many women and men interested in using it -- in sites with high prevalence of use of other methods, as well as in sites with very low prevalence. * It is effective -- more than 95% effective when used correctly. * It is easy to teach, learn and use. Most women can learn the method in a single 15-20 minute counseling session, and all levels of providers -- from clinicians to community volunteers -- can teach the method once they have been trained. * Clients can learn to use it correctly; CycleBeads are an excellent tool -- for learning and using the method. * Method use improves rapidly with practice. * Men support and collaborate with method use. * Involving the man is key to the successful use of the method, whether he is actively involved in using CycleBeads or just accepts the need to change behavior on fertile days. * Many couples prefer to use a condom during the fertile days, while others prefer to abstain. * It is necessary to educate health personnel at all levels to provide and support the method Slide 18 Although the Standard Days Method is appropriate for most women, there are several requirements that a woman interested in using the method should meet to achieve successful use: * The majority of her cycles should be between 26 and 32 days. If a woman does not know the approximate length of her menstrual cycles, this can be determined by a few simple questions. If her cycles usually last between 26 and 32 days, the woman will have approximately 95% protection from pregnancy if she uses the method correctly. While she is using the method, CycleBeads will help her know if her cycles are within this range. If she has 2 cycles outside this range during a year, her probability of pregnancy will be more than 5%, and she should be encouraged to use another method. * She and her partner should be able to use the method together. The collaboration of the man is extremely important for the successful use of the method. He needs to understand and accept that on days 8 through 19 of each cycle, they will need to use a condom or not have intercourse. If the man (or the woman) insists on having unprotected intercourse during the fertile days, they should be encouraged to use another method. * She should not be at risk of sexually transmitted infections. If either member of the couple is exposed to the risk of sexually transmitted infections, the Standard Days Method is not appropriate for them. Condoms are the only method that provide protection from these infections. Slide 19 What does the service provider do to offer the Standard Days Method to a potential user? * Determine that the client is interested in using the method * Ascertain whether the method is appropriate for her: that she has cycles between 26 and 32 days, that she can avoid unprotected intercourse on days 8 through 19 of each cycle, and that she is not exposed to the risk of sexually transmitted infections. * Explain the method to her. Demonstrate how to use CycleBeads to know which cycle day she is on, to see whether that is a day when she should avoid unprotected intercourse, and to determine whether her cycles are between 26 and 32 days long. * Have the client demonstrate how to use CycleBeads. * Verify that she understands that she should avoid unprotected intercourse on days 8 through 19 of each cycle. * Provide her with CycleBeads and any other materials to help her use the method. Slide 20 Public and private sector programs in countries around the world are offering the Standard Days Method. The Institute for Reproductive Health can provide technical assistance to programs that want to incorporate the Standard Days Method into their services. The Institute can help with: * A feasibility assessment and a plan for incorporating the Standard Days Method into existing services * Training of trainers * Technical assistance to ensure quality services * Support materials to assist with other activities related to service delivery Slide 21 The Institute has developed a number of materials to help programs incorporate the Standard Days Method and to support quality services to clients. Among these materials are: * A manual to train service providers. It can be adapted to a number of different circumstances. * A Service Delivery Guide (which is appropriate for staff with, and without, previous training in reproductive health). This document consists of two parts. The Selection Guide helps providers determine whether the method is appropriate for each potential user, and the Counseling Guide assists with teaching the method to clients. * A memory aide for selection and counseling is also helpful. * Client instructions for using the method are very important. * Visual materials to support Information, Education and Communication activities also help with outreach. Slide 22 In summary: * The Standard Days Method is a very simple natural method of family planning, and it can fill an existing gap in family planning services. * It is based on probabilities of becoming pregnant during the menstrual cycle and provides a high level of protection from unplanned pregnancy -- 95% with correct use. * Clients use a string of beads to track their cycle and identify days 8 through 19 as days to not engage in unprotected sex. Slide 23 Women have different needs for family planning, and their needs change during their lives. Offering a wide variety of methods -- including a natural method that is easy to teach, learn, and use -- helps meet these changing needs. For more information, please contact the following organizations: * The Institute for Reproductive Health can help programs that want to incorporate the method into their services in the United States and abroad. * The JHPIEGO Corporation can help integrate the method into preservice education and inservice training programs in developing countries.