Creighton Model Effectiveness, Intentions and Behaviors Assessment (CEIBA)
Condition: Pregnancy; Fertility
Study type: Observational

Summary: 
      The Creighton Model (CrM) FertilityCare System is a natural family planning method that
      teaches couples to recognize and chart the signs of fertility and infertility in the woman's
      cycle and to use that knowledge to either achieve or avoid a pregnancy. The method is
      natural, safe and effective, and it helps the couple understand their fertility. Trained
      practitioners at FertilityCare Centers teach the Creighton Model across the country,
      internationally and long distance.

      Several FertilityCare Centers and the University of Utah are conducting a study to evaluate
      the effectiveness of the Creighton Model (CrM) for new and return users wanting to avoid
      pregnancy. While past studies have shown that the Creighton Model is a highly effective
      method, this study will use new ways to measure how well it works. This is important because
      the knowledge gained will improve comparisons between the Creighton Model and other family
      planning methods. The study will also explore intentions and behaviors of couples to avoid or
      achieve a pregnancy.

      The investigators hypothesize that for the CrM the pregnancy rate during perfect use to avoid
      pregnancy will be about 1% and the behaviorally determined avoiding-related pregnancy rate
      for the CrM will be about 6%. The investigators will also evaluate the pregnancy rate during
      "typical use" without a previously stated intention to conceive (in CrM terms, a mixture of
      avoiding and achieving-related behavior).
    

Detailed description: 
      There are a variety of natural family planning (NFP) methods available today that differ in
      algorithm and biomarkers used to identify women's fertile window. This study will directly
      evaluate the NFP system known as the Creighton Model FertilityCare System (CrM). The
      Creighton Model System is a well-established educational system about fertility which
      involves no devices. The CrM teaches women a standardized way of observing and describing
      their vaginal discharge each day during routine use of the bathroom, and interpreting the
      changes in vaginal discharge to determine whether they are likely to be fertile that day or
      not. Vaginal discharge changes as tracked by the CrM are an accurate indicator of the changes
      in secretions from the uterine cervix that relate to the approach of ovulation.

      This study will also examine the relationship between a couple's stated intentions to achieve
      or avoid a pregnancy during each menstrual cycle with their sexual behavior during the same
      cycle. There is growing consensus among researchers that current measures of pregnancy
      intention are simplistic at best, and at worst can be very misleading. One of the purposes of
      the study is to explore the multiple dimensions of pregnancy motivations, intentions, and
      behaviors by newer detailed measures.

      This study will enroll couples who are new or returning CrM users and who are trying to avoid
      a pregnancy at the time they begin use of the CrM. The participants will be recruited from
      CrM FertilityCare Centers. The design is a prospective cohort study, which is the optimal
      study design to assess different measures of effectiveness and intendedness simultaneously in
      a group of NFP users. Several of the key measures of intention and behavior required for this
      study must be assessed prior to the outcome of actual use of CrM over time and the outcome of
      pregnancy, to avoid recall bias. Outcomes for this study require relatively precise
      assessment of the timing of both intentions and behaviors, which is simply unavailable from
      recall. We plan to enroll at least 300 and up to 400 couples in the study. This represents
      60% (300/497) of the estimated available and eligible couples learning the CrM for use to
      avoid pregnancy in one year at the participating FertilityCare Centers.
    

Intervention name(s): Creighton Model System of Natural Family Planning
Intervention type(s): Behavioral
Intervention description(s): Participants will learn the Creighton Model, a standardized method of natural family planning, from FertilityCare Practitioners from established FertilityCare Centers. The learning can be done in-person or long distance.
Other intervention name(s): Natural Family Planning; Ovulation Method; Fertility Awareness
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study will enroll couples who are new or return Creighton Model (CrM) users and who
        are trying to avoid a pregnancy at the time they begin use of the CrM. The participants
        will be recruited from several CrM FertilityCare Centers across the United States and
        Canada. Participants who do not live near a center will be offered long distance teaching.
      
Keywords: Natural Family Planning Methods; Ovulation Detection; Cervix Mucus; Intention; Behavior; Birth Control; Contraception; Pregnancy; Fertility