PregnancyPhase 3NCT00843336
Comparison of Two Internet Supported Natural Family Planning Methods
A Phase 3 study testing Electronic hormonal fertility monitoring and Self-monitoring in people with Pregnancy, run by Marquette University at 2 sites in United States.
Trial summary
The purpose of this research study is to compare the effectiveness of two natural family planning (NFP) methods that are provided over the internet by the Marquette University Institute for Natural Family Planning. One of the NFP methods is the use of a hand held electronic hormonal fertility monitor. Read more about this study
- Who is it for?
- Ages 18 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Electronic hormonal fertility monitoring and Self-monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 358 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2009to Dec 2013
- Phase
- Phase 3
- 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 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- be between the age of 18 and 42
- be in a sexually active committed relationship with a man
- have a menstrual cycle range of 21-42 days
- be between the ages of 18 and 50
- be in a sexually active committed relationship with his lone woman partner.
Who cannot join
- have not used Depo (injectable) contraception for the past 6 months
- have not used oral or patch hormonal contraception for the past 3 months
- have not breast-fed baby for at least three months
- have no known fertility problems
- not be using medications that interfere with fertility
- not smoke cigarettes; and
Show all 9Show fewer
- not be pregnant.
- For Male Participants
- have no known fertility problems
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Marquette University College of Nursing
Milwaukee, Wisconsin, 53201-1881
Marquette University
Milwaukee, Wisconsin, 53201-1881
About this study
Official title: Randomized Comparison of Two Internet Supported Natural Family Planning Methods
The purpose of this research study is to compare the effectiveness of two natural family planning (NFP) methods that are provided over the internet by the Marquette University Institute for Natural Family Planning. One of the NFP methods is the use of a hand held electronic hormonal fertility monitor. The other method involves the self-observation of cervical mucus to track fertility. Both of the methods will involve placing information about fertility into an online charting system that automatically displays the days of fertility and infertility. The investigators are also interested in the influence of mutual motivation by the woman and her partner in using these methods to avoid pregnancy. The investigators hypothesize that there will be lower unintended pregnancy rates among those couples who use the electronic hormonal fertility monitor and among those couples who have a strong motivation to avoid pregnancy.
Read the detailed description
The Office of Population Affairs (OPA) of the Department of Human Development recently submitted a call for proposals for research on methods of natural family planning (NFP). The department chairs of OPA have recognized that relatively few women in the United States use natural methods of family planning, especially in the Title X Family Planning programs and clinics. They wanted researchers to develop studies to help increase the use and the efficacy of these methods, and, furthermore, wanted to understand why the methods are not used more. Reasons why only about 0.2% of US women use natural methods of birth control are they are often difficult to use, they are relatively ineffective, and there is a lack of access to properly trained NFP teachers. At Marquette University we have developed simple methods of NFP that utilize an electronic fertility monitor that measures female reproductive hormones, self cervical mucus monitoring that estimates the fertile window, and a simple fertility formula to help estimate the beginning and end of the fertile window. We also have developed a Web site that offers easy access to information on NFP, electronic charting, and professional nurses with specialization in teaching NFP.
The specific purpose of our study is to determine the efficacy, satisfaction, ease of use, and motivation in using an internet based NFP method that utilizes an electronic hormonal fertility monitor plus a simple fertility formula (i.e., EHFM-NFP) within an online professional-nurse supported system. Since there are few studies that compare methods of NFP, another aim of this study is to compare an internet based EFHM-NFP method with an internet based traditional cervical mucus monitoring (CMM) NFP method - both methods were developed at Marquette University. Please note that we have 3 published efficacy studies of the Marquette Method.
The specific research questions that will be asked are:
- What are the 3, 6, and 12-month unintended pregnancy rates of an internet-provided EHFM-aided NFP method?
- What are the 3, 6, and 12-month unintended pregnancy rates of an internet-provided CMM-only NFP method?
- What is the satisfaction, ease of use, and mutual motivation of an internet-based NFP method (either EFHM or CMM) over a 12-month time period, i.e., after 1, 3, 6, and 12 months of use?
- Conditions
- Pregnancy
- Being tested
- Electronic hormonal fertility monitoring, Self-monitoring
- Keywords
- fertility monitoring, contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic hormonal fertility monitoringBehavioural
Also called ClearBlue Easy Fertility Monitor (Unipath, LTD).
Use of an electronic hormonal fertility monitor that provides three levels of fertility; low, high, and peak. Monitor is based upon urinary levels of E3G (estrogen) and LH. Monitor readings are placed in an electronic charting system on the Internet.
Self-monitoringBehavioural
Also called Ovulation method
Self-monitoring of externally observed cervical mucus to determine level of fertility.
| Study group | Role | What they receive |
|---|---|---|
| Electronic hormonal fertility monitoring | Experimental | Use of an electronic hormonal fertility monitor that measures urinary estrogen and LH and provides users with low, high, or peak fertility readings. Receives: Behavioral: Electronic hormonal fertility monitoring |
| Cervical mucus monitoring | Active comparator | Self-monitoring of externally observed cervical mucus to determine level of fertility. Receives: Behavioral: Self-monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unintended Pregnancies
Survival analysis of based on unintended pregnancies and correct use menstrual cycles (for perfect use analysis) and typical use (based on total number of menstrual cycles) -- to be calculated at 1, 3, 6, and 12 months of use. A Kaplan-Meier survival curve over that time period will be displayed to show change.
Measured: 1, 3, 6, and 12 months
Secondary outcomes (1)
user satisfaction, ease of use, mutual motivation
To determine if there is significant change from baseline (at 1 month) to 3, 6 and 12 months in the outcome measure of "satisfaction and ease of use" - repeated measure analysis (ANOVA) will be used. Change in motivation to avoid pregnancy from baseline (i.e., before charting the first menstrual cycle) through 12 months of use will also be analyzed for changes by repeated measure analysis. We will also use repeated measure analysis to determine differences in the outcome measures between the two study groups.
Measured: 1, 3, 6 and 12 months; mutual motivation monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 358 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard J. Fehring, Marquette University
- Investigators
- Richard J Fehring, PhD, Principal investigator, Marquette University College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00843336
- Sponsor's protocol ID
- FPR200801363
- Status last verified
- Sep 2015
- First submitted
- 12 Feb 2009
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Fehring RJ, Schneider M, Barron ML. Efficacy of the Marquette Method of natural family planning. MCN Am J Matern Child Nurs. 2008 Nov-Dec;33(6):348-54. doi: 10.1097/01.NMC.0000341254.80426.32.
PubMed 18997569Fehring RJ, Schneider M, Raviele K, Barron ML. Efficacy of cervical mucus observations plus electronic hormonal fertility monitoring as a method of natural family planning. J Obstet Gynecol Neonatal Nurs. 2007 Mar-Apr;36(2):152-60. doi: 10.1111/j.1552-6909.2007.000129.x.
PubMed 17371516Fehring RJ, Schneider M, Barron ML, Raviele K. Cohort comparison of two fertility awareness methods of family planning. J Reprod Med. 2009 Mar;54(3):165-70.
PubMed 19370902Fehring RJ, Schneider M, Raviele K, Rodriguez D, Pruszynski J. Randomized comparison of two Internet-supported fertility-awareness-based methods of family planning. Contraception. 2013 Jul;88(1):24-30. doi: 10.1016/j.contraception.2012.10.010. Epub 2012 Nov 12.
PubMed 23153900
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Two Internet Supported Natural Family Planning Methods
- ClinicalTrials.gov ID
- NCT00843336
- Acronym / sponsor ID
- FPR200801363
- Conditions
- Pregnancy
- Keywords
- fertility monitoring, contraception
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 358 participants (actual)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 13 Feb 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 purpose of this research study is to compare the effectiveness of two natural family planning (NFP) methods that are provided over the internet by the Marquette University Institute for Natural Family Planning. One of the NFP methods is the use of a hand held electronic hormonal fertility monitor. The other method involves the self-observation of cervical mucus to track fertility. Both of the methods will involve placing information about fertility into an online charting system that automatically displays the days of fertility and infertility. The investigators are also interested in the influence of mutual motivation by the woman and her partner in using these methods to avoid pregnancy. The investigators hypothesize that there will be lower unintended pregnancy rates among those couples who use the electronic hormonal fertility monitor and among those couples who have a strong motivation to avoid pregnancy.
Detailed description
The Office of Population Affairs (OPA) of the Department of Human Development recently submitted a call for proposals for research on methods of natural family planning (NFP). The department chairs of OPA have recognized that relatively few women in the United States use natural methods of family planning, especially in the Title X Family Planning programs and clinics. They wanted researchers to develop studies to help increase the use and the efficacy of these methods, and, furthermore, wanted to understand why the methods are not used more. Reasons why only about 0.2% of US women use natural methods of birth control are they are often difficult to use, they are relatively ineffective, and there is a lack of access to properly trained NFP teachers. At Marquette University we have developed simple methods of NFP that utilize an electronic fertility monitor that measures female reproductive hormones, self cervical mucus monitoring that estimates the fertile window, and a simple fertility formula to help estimate the beginning and end of the fertile window. We also have developed a Web site that offers easy access to information on NFP, electronic charting, and professional nurses with specialization in teaching NFP.
The specific purpose of our study is to determine the efficacy, satisfaction, ease of use, and motivation in using an internet based NFP method that utilizes an electronic hormonal fertility monitor plus a simple fertility formula (i.e., EHFM-NFP) within an online professional-nurse supported system. Since there are few studies that compare methods of NFP, another aim of this study is to compare an internet based EFHM-NFP method with an internet based traditional cervical mucus monitoring (CMM) NFP method - both methods were developed at Marquette University. Please note that we have 3 published efficacy studies of the Marquette Method.
The specific research questions that will be asked are:
- What are the 3, 6, and 12-month unintended pregnancy rates of an internet-provided EHFM-aided NFP method?
- What are the 3, 6, and 12-month unintended pregnancy rates of an internet-provided CMM-only NFP method?
- What is the satisfaction, ease of use, and mutual motivation of an internet-based NFP method (either EFHM or CMM) over a 12-month time period, i.e., after 1, 3, 6, and 12 months of use?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic hormonal fertility monitoring | Experimental | Behavioral: Electronic hormonal fertility monitoringUse of an electronic hormonal fertility monitor that measures urinary estrogen and LH and provides users with low, high, or peak fertility readings. |
| Cervical mucus monitoring | Active comparator | Behavioral: Self-monitoringSelf-monitoring of externally observed cervical mucus to determine level of fertility. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- be between the age of 18 and 42
- be in a sexually active committed relationship with a man
- have a menstrual cycle range of 21-42 days
- be between the ages of 18 and 50
- be in a sexually active committed relationship with his lone woman partner.
Key exclusion criteria (9 listed)
- have not used Depo (injectable) contraception for the past 6 months
- have not used oral or patch hormonal contraception for the past 3 months
- have not breast-fed baby for at least three months
- have no known fertility problems
- not be using medications that interfere with fertility
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 |
|---|---|---|
| Electronic hormonal fertility monitoringAlso: ClearBlue Easy Fertility Monitor (Unipath, LTD).Use of an electronic hormonal fertility monitor that provides three levels of fertility; low, high, and peak. Monitor is based upon urinary levels of E3G (estrogen) and LH. Monitor readings are placed in an electronic charting system on the Internet. | Behavioural | Electronic hormonal fertility monitoring |
| Self-monitoringAlso: Ovulation methodSelf-monitoring of externally observed cervical mucus to determine level of fertility. | Behavioural | Cervical mucus monitoring |
Primary outcome
Unintended Pregnancies
Time frame: 1, 3, 6, and 12 months
Survival analysis of based on unintended pregnancies and correct use menstrual cycles (for perfect use analysis) and typical use (based on total number of menstrual cycles) -- to be calculated at 1, 3, 6, and 12 months of use. A Kaplan-Meier survival curve over that time period will be displayed to show change.
1 secondary outcome
user satisfaction, ease of use, mutual motivation
Time frame: 1, 3, 6 and 12 months; mutual motivation monthly
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 24 Sep 2015.
- Background: PubMed 18997569Fehring RJ, Schneider M, Barron ML. Efficacy of the Marquette Method of natural family planning. MCN Am J Matern Child Nurs. 2008 Nov-Dec;33(6):348-54. doi: 10.1097/01.NMC.0000341254.80426.32.
- Background: PubMed 17371516Fehring RJ, Schneider M, Raviele K, Barron ML. Efficacy of cervical mucus observations plus electronic hormonal fertility monitoring as a method of natural family planning. J Obstet Gynecol Neonatal Nurs. 2007 Mar-Apr;36(2):152-60. doi: 10.1111/j.1552-6909.2007.000129.x.
- Background: PubMed 19370902Fehring RJ, Schneider M, Barron ML, Raviele K. Cohort comparison of two fertility awareness methods of family planning. J Reprod Med. 2009 Mar;54(3):165-70.
- Derived from this study: PubMed 23153900Fehring RJ, Schneider M, Raviele K, Rodriguez D, Pruszynski J. Randomized comparison of two Internet-supported fertility-awareness-based methods of family planning. Contraception. 2013 Jul;88(1):24-30. doi: 10.1016/j.contraception.2012.10.010. Epub 2012 Nov 12.
- Marquette NFP Institute Research Web pageLink 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.
Richard J Fehring, PhD principal investigator
Marquette University College of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Electronic hormonal fertility monitoring and Self-monitoring in people with Pregnancy, run by Marquette University at 2 sites in United States.
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 5 inclusion and 9 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 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Unintended Pregnancies (time frame: 1, 3, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00843336, which also lists 4 linked publications.
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 24 Sep 2015.