Comparison of Two Internet Supported Natural Family Planning Methods
Randomized Comparison of Two Internet Supported Natural Family Planning Methods
1 other identifier
interventional
358
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 pregnancy
Started Feb 2009
Typical duration for phase_3 pregnancy
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 12, 2009
CompletedFirst Posted
Study publicly available on registry
February 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedSeptember 24, 2015
September 1, 2015
3.8 years
February 12, 2009
September 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1, 3, 6, and 12 months
Secondary Outcomes (1)
user satisfaction, ease of use, mutual motivation
1, 3, 6 and 12 months; mutual motivation monthly
Study Arms (2)
Electronic hormonal fertility monitoring
EXPERIMENTALUse 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 COMPARATORSelf-monitoring of externally observed cervical mucus to determine level of fertility.
Interventions
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-monitoring of externally observed cervical mucus to determine level of fertility.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- not be pregnant.
- For Male Participants
- be between the ages of 18 and 50
- be in a sexually active committed relationship with his lone woman partner.
- have no known fertility problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Marquette University College of Nursing
Milwaukee, Wisconsin, 53201-1881, United States
Marquette University
Milwaukee, Wisconsin, 53201-1881, United States
Related Publications (4)
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.
PMID: 18997569BACKGROUNDFehring 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.
PMID: 17371516BACKGROUNDFehring 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.
PMID: 19370902BACKGROUNDFehring 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.
PMID: 23153900DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard J Fehring, PhD
Marquette University College of Nursing
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 12, 2009
First Posted
February 13, 2009
Study Start
February 1, 2009
Primary Completion
December 1, 2012
Study Completion
December 1, 2013
Last Updated
September 24, 2015
Record last verified: 2015-09