PregnancyCEIBANCT01012596
Creighton Model Effectiveness, Intentions and Behaviors Assessment (CEIBA)
An observational study of Pregnancy and Fertility, run by University of Utah at 18 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- What is being tested?
- Creighton Model System of Natural Family Planning
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 624 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Oct 2009to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States17 sites
St. Joseph FertilityCare Center
Albuquerque, New Mexico, 87120
FertilityCare Center of Kansas City
Blue Springs, Missouri, 64014
Center for Women's Health, Spirit FertilityCare Services
Camp Hill, Pennsylvania, 17011
Northland Family Programs: A FertilityCare Center
Duluth, Minnesota, 55102
FertilityCare Center of North Texas
Fort Worth, Texas, 76137
FertilityCare Services: Diocese of Charleston, SC
Greer, South Carolina, 29650
Women's FertilityCare Services of Houston
Houston, Texas, 88018
FertilityCare Center, Diocese of Lincoln
Lincoln, Nebraska, 68501
FertilityCare Services St. Joseph Hospital
Nashua, New Hampshire, 03060
FertilityCare Center of Omaha
Omaha, Nebraska, 68106
Caritas FertilityCare Center
Pataskala, Ohio, 43062
Sacramento Diocese FertilityCare Services
Sacramento, California, 95825
Twin Cities FertilityCare Center
Saint Paul, Minnesota, 55102
Intermountain FertilityCare Center
Salt Lake City, Utah, 84106
If you don't find a center near you, contact us for Long Distance Learning
Salt Lake City, Utah, 84112
St. John's Mercy Medical Center, Department of FertilityCare Services
St Louis, Missouri, 63141
FertilityCare Center of the Upper Ohio Valley
Weirton, West Virginia, 26062
Canada1 site
Marguerite Bourgeoys FertilityCare Programme
Toronto, Ontario, M4C 3B7
About this study
Official title: Effectiveness, Intention, and Behavior in Creighton Model NFP Use
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).
Read the 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.
- Being tested
- Creighton Model System of Natural Family Planning
- Keywords
- Natural Family Planning Methods, Ovulation Detection, Cervix Mucus, Intention, Behavior, Birth Control, Contraception, Pregnancy, Fertility
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creighton Model System of Natural Family PlanningBehavioural
Also called Natural Family Planning, Ovulation Method, Fertility Awareness
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.
| Study group | Role | What they receive |
|---|---|---|
| Creighton Model | New and return users of the Creighton Model FertilityCare System, a method of Natural Family Planning. Receives: Behavioral: Creighton Model System of Natural Family Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 624 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Principal investigator, Joseph B. Stanford, MD, MSPH, University of Utah
- Investigators
- Joseph B Stanford, MD, MSPH, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01012596
- Sponsor's protocol ID
- 34487
- Other IDs
- PA-FPR-08-38, PA-FPR-001-009858, CEIBA-93.974
- Acronym
- CEIBA
- Status last verified
- Feb 2022
- First submitted
- 2 Nov 2009
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness, Intention, and Behavior in Creighton Model NFP Use
- ClinicalTrials.gov ID
- NCT01012596
- Acronym / sponsor ID
- CEIBA / 34487
- Keywords
- Natural Family Planning Methods, Ovulation Detection, Cervix Mucus, Intention, Behavior, Birth Control, Contraception, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 624 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- Oct 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 13 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Creighton Model | – | Behavioral: Creighton Model System of Natural Family PlanningNew and return users of the Creighton Model FertilityCare System, a method of Natural Family Planning. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creighton Model System of Natural Family PlanningAlso: Natural Family Planning, Ovulation Method, Fertility AwarenessParticipants 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. | Behavioural | Creighton Model |
Primary outcome
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
Time frame: 1 year
1 secondary outcome
The intention status of all pregnancies according to standard measures of intended, mistimed and unwanted pregnancy while recognizing the significant limitations of these measures
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Study WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph B Stanford, MD, MSPH principal investigator
University of Utah
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Fertility, run by University of Utah at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.