Creighton Model Effectiveness, Intentions and Behaviors Assessment (CEIBA)
NCT ID: NCT01012596
Last Updated: 2022-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
624 participants
OBSERVATIONAL
2009-10-31
2013-05-31
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Creighton Model
New and return users of the Creighton Model FertilityCare System, a method of Natural Family Planning.
Creighton Model System of Natural Family Planning
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.
Interventions
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Creighton Model System of Natural Family Planning
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 Names
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Eligibility Criteria
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Inclusion Criteria
* Sexually active or planning to be sexually active within 6 months of the enrollment date (relevant to some engaged couples who learn CrM)
* The woman is between the ages of 18 to 40
* The man is age 18 or older
* The woman has had at least 2 menstrual flows in the past 3 months or at least one menstrual flow since stopping hormonal birth control
* The woman is able to complete questionnaires in English
Exclusion Criteria
* Confirmed pelvic inflammatory disease, surgically confirmed untreated endometriosis, chemotherapy (either man or woman), or radiation to the reproductive tract (either man or woman)
* Hysterectomy, oophorectomy (ovary removed), tubal ligation, fallopian tube surgery, surgery for ectopic pregnancy, removal of a testicle (orchiectomy) or vasectomy
* Depo-Provera injection any time in the past 2 years
* Totally breastfeeding an infant, without any supplements
18 Years
40 Years
ALL
Yes
Sponsors
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Department of Health and Human Services
FED
University of Utah
OTHER
Responsible Party
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Joseph B. Stanford, MD, MSPH
Principal Investigator
Principal Investigators
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Joseph B Stanford, MD, MSPH
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Locations
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Sacramento Diocese FertilityCare Services
Sacramento, California, United States
Northland Family Programs: A FertilityCare Center
Duluth, Minnesota, United States
Twin Cities FertilityCare Center
Saint Paul, Minnesota, United States
FertilityCare Center of Kansas City
Blue Springs, Missouri, United States
St. John's Mercy Medical Center, Department of FertilityCare Services
St Louis, Missouri, United States
FertilityCare Center, Diocese of Lincoln
Lincoln, Nebraska, United States
FertilityCare Center of Omaha
Omaha, Nebraska, United States
FertilityCare Services St. Joseph Hospital
Nashua, New Hampshire, United States
St. Joseph FertilityCare Center
Albuquerque, New Mexico, United States
Caritas FertilityCare Center
Pataskala, Ohio, United States
Center for Women's Health, Spirit FertilityCare Services
Camp Hill, Pennsylvania, United States
FertilityCare Services: Diocese of Charleston, SC
Greer, South Carolina, United States
FertilityCare Center of North Texas
Fort Worth, Texas, United States
Women's FertilityCare Services of Houston
Houston, Texas, United States
Intermountain FertilityCare Center
Salt Lake City, Utah, United States
If you don't find a center near you, contact us for Long Distance Learning
Salt Lake City, Utah, United States
FertilityCare Center of the Upper Ohio Valley
Weirton, West Virginia, United States
Marguerite Bourgeoys FertilityCare Programme
Toronto, Ontario, Canada
Countries
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Related Links
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Other Identifiers
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PA-FPR-08-38
Identifier Type: -
Identifier Source: secondary_id
PA-FPR-001-009858
Identifier Type: -
Identifier Source: secondary_id
CEIBA-93.974
Identifier Type: -
Identifier Source: secondary_id
34487
Identifier Type: -
Identifier Source: org_study_id
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