Creighton Model Effectiveness, Intentions and Behaviors Assessment (CEIBA)

Completed

Conditions studied: Pregnancy, Fertility

In brief

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).

Key facts

Study ID

NCT01012596

Run by

University of Utah

People needed

624

Starts

2009-10-01

Expected to finish

2013-05-01

Last updated by the study team

2022-02-23

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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