MyNewOptions: An Online Study of Reproductive Life Planning and Contraceptive Action Planning

Unintended Pregnancy Clinical Trial

— MyNewOptions  

Official title:

Reducing Unintended Pregnancies Through Reproductive Life Planning and Contraceptive Action Planning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02100124
• Other study ID #: CD-1304-6117
• Secondary ID: CD-1304-6117
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: September 2016

Study information

• Verified date: September 2017
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this web-based study is to determine whether reproductive life planning (RLP), with or without contraceptive action planning (RLP+), will result in reduced risk of unintended pregnancy when compared to an information-only control group.

Description:

Most US families want 2 children, resulting in the average woman spending 3 decades of her life trying to avoid pregnancy. However, most women have at least one unintended pregnancy, resulting in 1.5 million abortions and 1.7 million unintended births annually. Women and couples try to avoid unintended pregnancy for a range of personal, social, and economic reasons, but also due to the increased physical and mental health effects for children that result from unintended pregnancy. Healthcare reform now requires that private health insurance companies cover all FDA-approved contraceptive methods with no copays or deductibles to the patient, creating a great opportunity for women with health insurance to get contraceptive methods they previously could not afford. In this study, women with health insurance will be randomly assigned to one of three groups: (1) Reproductive Life Planning (RLP)—women will complete a reproductive life plan that guides them to think about if and when they would want any future pregnancies, and to determine what contraceptive method(s) are best suited to them; (2) Reproductive Life Planning Plus (RLP+) which additionally includes "if-then planning," where women determine what they will do when they encounter difficult situations that make it difficult to use their contraceptive method perfectly; or (3) an information-only control group. The online format of the study allows for the potential of wide dissemination. The RLP and RLP+ interventions are expected to result in greater likelihood of contraceptive use, continuity of contraceptive use, and contraceptive adherence, and thus reduce overall risk of unintended pregnancy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 987
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• not currently pregnant

• sexually active with a male partner in the past 6 months OR anticipate being sexually active with a male partner in the next 6 months

• does not intend pregnancy in the next 12 months

• has Internet access and email address

Exclusion Criteria:

• tubal sterilization

• hysterectomy

• partner with vasectomy

Related Conditions & MeSH terms

• Contraceptive Use
• Unintended Pregnancy

Intervention

Behavioral:
• Reproductive Life Planning (RLP)

• Contraceptive Action Planning

• Contraception information

Locations

Country	Name	City	State
United States	Penn State College of Medicine	Hershey	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contraceptive Use	Percentage of surveys with any contraceptive use	24 months
Secondary	Effectiveness of Contraceptive Method	Percentage of surveys where most effective contraceptive method used	24 months
Secondary	Contraceptive Method Satisfaction	percentage of surveys where very satisfied with contraceptive method	24 months
Secondary	Contraceptive Adherence	Percentage of surveys where contraceptive adherence was high	24 months