Elsevier

Contraception

Volume 69, Issue 3, March 2004, Pages 201-206
Contraception

Original research article
The importance of screening and monitoring: the Standard Days Method and cycle regularity

https://doi.org/10.1016/j.contraception.2003.11.007Get rights and content

Abstract

The Standard Days Method™ is a simple fertility awareness-based method of family planning with a correct-use pregnancy rate of 4.8 at 1 year and a typical-use pregnancy rate of 12. The protocol for providing the method includes guidelines for screening potential users for cycle regularity. There also are guidelines for monitoring users to determine continued method eligibility. This article explores the importance of these screening and monitoring procedures. A large existing dataset from a World Health Organization study of the Ovulation Method was used to estimate the theoretical probability of pregnancy using the Standard Days Method, with and without screening and monitoring. We used data from the efficacy study of the Standard Days Method to examine the effectiveness of current screening and monitoring procedures. Results suggest that current screening and monitoring procedures are useful in identifying women for whom the Standard Days Method is less effective. Strict adherence to these procedures is ideal, but even women who do not meet the cycle-regularity guidelines would have a relatively low probability of pregnancy.

Introduction

When potential users contact a family-planning service provider, they often have a specific method in mind. Receiving that method is a good predictor of continued use [1]. Ideally, the method the woman selects would be appropriate for her. However, not all family-planning methods are suitable for all potential users. Some family-planning methods are more appropriate than others for individual women. It is important that the woman gets a method that she can use correctly, and that would not harm her health. Other requirements for correct method use also need to be considered, particularly for user-dependent methods.

Initial screening is essential to help providers and women choose suitable methods. Screening guidelines should strike a balance between being sufficiently selective and as inclusive as possible, to allow the greatest number of clients to access the method. For most methods, a degree of ongoing monitoring is desirable to assess whether the method continues to be appropriate for the woman [2], [3]. Specific guidelines have been developed for each method to assist clients and providers in making appropriate decisions on which method to offer [4], [5]. This article examines initial screening and monitoring for the Standard Days Method™—a fertility awareness-based method of family planning focusing on cycle regularity.

The Standard Days Method was developed by the Institute for Reproductive Health, Georgetown University (IRH), to help fill the need for simple, effective, fertility awareness-based methods of family planning. A significant number of women worldwide use periodic abstinence as their method of family planning [6]. Research indicates that many of these women do not know how to correctly determine when they are fertile, which accounts for many unplanned pregnancies. For women who desire to use fertility awareness-based methods of family planning, one of the barriers to achieving their family-planning goals is the relative complexity of established effective methods, such as the Ovulation Method and the Symptothermal Method, which require a substantial investment of time in teaching and follow-up. In many developing countries, therefore, there is a high demand for an effective fertility awareness-based method, such as the Standard Days Method, that is easy for providers to teach and for users to learn and use. One of the main attributes of the Standard Days Method is its inherent simplicity.

The Standard Days Method requires simply that women whose cycles usually range from 26 to 32 days long should avoid unprotected intercourse on days 8–19 (inclusive) of their cycle if they do not want to become pregnant. The method can be offered with CycleBeads™, a string of color-coded beads, to help users keep track of which cycle day they are on and monitor their cycle lengths. An analysis of the theoretical effectiveness of the Standard Days Method showed that the method would be extremely effective for women with cycles of 26–32 days, and would substantially reduce the probability of pregnancy for women who occasionally have a cycle that is shorter or longer [7]. Therefore, the current protocol for Standard Days Method use recommends that users who have a second out-of-range cycle in a year switch to another method.

An efficacy trial of the Standard Days Method, following 478 women for up to 13 cycles of method use in five sites in Bolivia, Peru and the Philippines, resulted in a 4.8 1-year pregnancy rate with self-reported correct use of the method. A 1-year pregnancy rate of 12 was calculated when taking into account all cycles and all pregnancies, including pregnancies that occurred in cycles in which users had unprotected intercourse on days identified as fertile [8].

Since the method works best for women whose cycles usually range from 26 to 32 days, study participants were screened for habitual cycle length prior to admission, and were monitored for cycle length throughout the study. But is this screening and monitoring necessary? If so, is it sufficient? This article addresses these questions, which have important programmatic implications.

Section snippets

Data and methodology

We compare patterns of cycle length of participants in two studies—the efficacy study of the Standard Days Method, in which women were screened for cycle regularity and monitored for cycle length, and a study of Ovulation Method users conducted by the World Health Organization (WHO), where screening was less stringent and there was no monitoring for continued cycle regularity. We use the WHO data also to examine the impact of not screening and monitoring on the theoretical effectiveness of the

Are screening and monitoring necessary?

The ideal methodology for studying the benefit of screening for cycle regularity of potential Standard Days Method users is to examine the number of pregnancies among women who were screened or not screened, and compare the number of pregnancies for women who had a cycle out of range to those who did not. However, our data do not allow us to do so because there were too few pregnancies during the efficacy trial of the Standard Days Method. Only 43 of the 478 women became pregnant during their

Discussion

Our results clearly indicate the importance and effectiveness of screening and monitoring, and suggest that the screening and monitoring mechanisms used during the efficacy study significantly reduce the probability of Standard Days Method users having cycles out of the 26–32-day range. But is this sufficient?

Acknowledgements

Support for the analysis and preparation of this article was provided by the Institute for Reproductive Health, Department of Obstetrics and Gynecology at Georgetown University, Washington, DC, which is funded under a cooperative agreement HRN-A-00-97-00011-00 with the United States Agency for International Development. The views expressed by the authors do not necessarily reflect the views or policies of USAID or Georgetown University.

References (13)

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  • New Approaches to Fertility Awareness-Based Methods: Incorporating the Standard Days and TwoDay Methods into Practice

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    CycleBeads help women monitor their cycle lengths. The Standard Days Method is not as effective for women with cycles outside the 26 to 32 day range.18 Therefore, women who have more than one cycle longer than 32 days or shorter than 26 days in a 12-month period should return to their provider to consider another method.

  • Variability in the phases of the menstrual cycle

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