Creighton Model Effectiveness, Intentions and Behaviors Assessment (CEIBA)
CEIBA
Effectiveness, Intention, and Behavior in Creighton Model NFP Use
4 other identifiers
observational
624
2 countries
18
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2009
Typical duration for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 2, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFebruary 23, 2022
February 1, 2022
3 years
November 2, 2009
February 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pregnancy rates during perfect and typical use of the Creighton Model FertilityCare System (CrM) to avoid pregnancy in a way directly comparable to the approach used in recent family planning effectiveness studies
1 year
Secondary Outcomes (1)
The intention status of all pregnancies according to standard measures of intended, mistimed and unwanted pregnancy while recognizing the significant limitations of these measures
1 year
Study Arms (1)
Creighton Model
New and return users of the Creighton Model FertilityCare System, a method of Natural Family Planning.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- Being a new or return user of the Creighton Model with the stated intention of avoiding pregnancy
- 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
You may not qualify if:
- History of infertility
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- Department of Health and Human Servicescollaborator
Study Sites (18)
Sacramento Diocese FertilityCare Services
Sacramento, California, 95825, United States
Northland Family Programs: A FertilityCare Center
Duluth, Minnesota, 55102, United States
Twin Cities FertilityCare Center
Saint Paul, Minnesota, 55102, United States
FertilityCare Center of Kansas City
Blue Springs, Missouri, 64014, United States
St. John's Mercy Medical Center, Department of FertilityCare Services
St Louis, Missouri, 63141, United States
FertilityCare Center, Diocese of Lincoln
Lincoln, Nebraska, 68501, United States
FertilityCare Center of Omaha
Omaha, Nebraska, 68106, United States
FertilityCare Services St. Joseph Hospital
Nashua, New Hampshire, 03060, United States
St. Joseph FertilityCare Center
Albuquerque, New Mexico, 87120, United States
Caritas FertilityCare Center
Pataskala, Ohio, 43062, United States
Center for Women's Health, Spirit FertilityCare Services
Camp Hill, Pennsylvania, 17011, United States
FertilityCare Services: Diocese of Charleston, SC
Greer, South Carolina, 29650, United States
FertilityCare Center of North Texas
Fort Worth, Texas, 76137, United States
Women's FertilityCare Services of Houston
Houston, Texas, 88018, United States
Intermountain FertilityCare Center
Salt Lake City, Utah, 84106, United States
If you don't find a center near you, contact us for Long Distance Learning
Salt Lake City, Utah, 84112, United States
FertilityCare Center of the Upper Ohio Valley
Weirton, West Virginia, 26062, United States
Marguerite Bourgeoys FertilityCare Programme
Toronto, Ontario, M4C 3B7, Canada
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph B Stanford, MD, MSPH
University of Utah
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 2, 2009
First Posted
November 13, 2009
Study Start
October 1, 2009
Primary Completion
October 1, 2012
Study Completion
May 1, 2013
Last Updated
February 23, 2022
Record last verified: 2022-02