Comparison of Two Internet Supported Natural Family Planning Methods

Pregnancy Clinical Trial

Official title:

Randomized Comparison of Two Internet Supported Natural Family Planning Methods

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00843336
• Other study ID #: FPR200801363
• Status: Completed
• Phase: Phase 3
• First received: February 12, 2009
• Last updated: September 22, 2015
• Start date: February 2009
• Est. completion date: December 2013

Study information

• Verified date: September 2015
• Source: Marquette University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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:

1. What are the 3, 6, and 12-month unintended pregnancy rates of an internet-provided EHFM-aided NFP method?

2. What are the 3, 6, and 12-month unintended pregnancy rates of an internet-provided CMM-only NFP method?

3. 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: December 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 42 Years

Eligibility

For Female participants

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Inclusion criteria:

• be between the ages of 18 and 50

• be in a sexually active committed relationship with his lone woman partner.

Exclusion criteria:

• have no known fertility problems

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnancy

Intervention

Behavioral:
• Electronic hormonal fertility monitoring
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
Self-monitoring of externally observed cervical mucus to determine level of fertility.

Locations

Country	Name	City	State
United States	Marquette University	Milwaukee	Wisconsin
United States	Marquette University College of Nursing	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Marquette University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Fehring 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. — View Citation

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. — View Citation

Fehring 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	1, 3, 6 and 12 months; mutual motivation monthly	No

External Links

•   Marquette NFP Institute Research Web page
•   The NFP Study Web site