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Completed

NCT Number: NCT02100124

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Penn State College of Medicine

Hershey, Pennsylvania, 17033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Reproductive Life Planning (RLP)

Behavioral

Contraceptive Action Planning

Behavioral

Contraception information

Behavioral

Primary outcomes

  1. Contraceptive Use

    Time frame: 24 months

    Percentage of surveys with any contraceptive use

Secondary outcomes

  1. Effectiveness of Contraceptive Method

    Time frame: 24 months

    Percentage of surveys where most effective contraceptive method used

  2. Contraceptive Method Satisfaction

    Time frame: 24 months

    percentage of surveys where very satisfied with contraceptive method

  3. Contraceptive Adherence

    Time frame: 24 months

    Percentage of surveys where contraceptive adherence was high

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Reducing Unintended Pregnancies Through Reproductive Life Planning and Contraceptive Action Planning

Acronym: MyNewOptions

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 31, 2014
Registry last updated
Jul 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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