Efficacy of the Standard Days Method of Family Planning
Condition: Women's Health
Study type: Interventional

Summary: 
      The Standard Days Method® is a fertility awareness-based method of family planning in which
      users avoid unprotected intercourse during cycle day 8 through 19. The method is most
      appropriate for women with cycles that usually range 26-32 days. The clinical trial tested
      the contraceptive efficacy of the Standard Days Method. A total of 478 women, age 18-39
      years, in Bolivia, Peru, and the Philippines, with self-reported cycles of 26-32 days,
      desiring to delay pregnancy at least one year were admitted to the study and followed for up
      to 13 cycles of method use.
    

Detailed description: 
      The Standard Days Method® is a fertility awareness-based method of family planning. Users
      avoid unprotected intercourse during cycle day 8 through cycle day 19. The method is most
      effective for women with cycles that usually range 26-32 days. It was developed by applying
      various formulae (i.e. various numbers of days and various sets of days) to over 7500
      menstrual cycles in an existing data set from the World Health Organization, to determine
      which formula would provide the optimal balance between he length of the identified fertile
      period and the efficacy in avoiding unplanned pregnancy.

      The purpose of the clinical trial was to test the efficacy of the method in preventing
      pregnancy.

      Participants were from five sites in Bolivia, Peru, and the Philippines. In all sites, the
      Institute for Reproductive Health trained 5-10 health workers (service providers) in teaching
      the Standard Days Method to study subjects and in study procedures. Method provision involved
      a counseling session in which the woman (or the couple, if her partner was available) was
      instructed in the use of the method, and counseled on the importance of following the method
      recommendations to avoid pregnancy.

      To assist women in monitoring their cycles, the provider gave them CycleBeads® a mnemonic
      device, a string of 32 beads in which each beads represents a day of the menstrual cycle. The
      first bead is red, representing the first day of menses; the next 6 beads are brown,
      representing the additional non-fertile days preceding the fertile window; the next 12 beads
      are white, representing days that should be considered fertile (8-19); and the remaining 13
      beads are brown, again representing non-fertile days. It also has a moveable, tight-fitting
      rubber ring that is used to mark the current day of the cycle. Women were instructed to place
      the ring on the red bead on the day their menses began, and move the ring one bead per day
      until their menses returned. They also were told that to avoid pregnancy they should not have
      unprotected intercourse on the days the ring was on a white bead. If they had menstrual
      bleeding before day 27 of the cycle (i.e., a cycle shorter than 26 days), or if their menses
      had not occurred by the day after they completed all 32 beads (i.e., a cycle longer than 32
      days), they were instructed to contact their provider for further assessment and advice.
      Women who had two cycles outside the 26 through 32 day range during the study period were
      advised to use another method, and were withdrawn from the study.

      A total of 478 women wishing to use the Standard Days Method and meeting the eligibility
      criteria were admitted to the study after signing an informed consent form and interviewed
      monthly until they either completed 13 cycles of method use or left the study for other
      reasons. The first level of data collection was administered by the clients themselves. Each
      woman was asked to keep a daily diary to record menstrual bleeding, intercourse, and use of
      any other contraceptive method. The information on the diary card was reviewed by the clients
      and the service provider during each of the monthly follow-up contacts. In addition,
      follow-up forms were administered, which included questions concerning method use,
      satisfaction, and willingness to continue in the study.

      Women who had not had their menses by day 42 of their cycle were tested for pregnancy. If
      results were negative, they were followed until they tested positive or their menses
      returned. Loss to follow-up was minimized by interviewing study participants in their homes
      and actively seeking out each participant, with a minimum of three attempts per cycle.

      Single-decrement multi-censoring life tables were used to calculate pregnancy rates.
    

Intervention name(s): Standard Days Method
Intervention type(s): Behavioral
Intervention description(s): The Standard Days Method is a fertility awareness-based method of family planning. Users avoid unprotected intercourse during cycle days 8 to 19. Study participants were for up to 13 cycles of method use.
Other intervention name(s): CycleBeads
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: fertility awareness-based method; family planning; Standard Days Method; Institute for Reproductive Health; Efficacy; CycleBeads