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临床试验/NCT02100124
NCT02100124已完成不适用

Reducing Unintended Pregnancies Through Reproductive Life Planning and Contraceptive Action Planning

Milton S. Hershey Medical Center2 个研究点 分布在 1 个国家目标入组 987 人开始时间: 2014年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
987
试验地点
2
主要终点
Contraceptive Use

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • tubal sterilization
  • hysterectomy
  • partner with vasectomy

研究组 & 干预措施

Reproductive Life Planning (RLP)

Experimental

RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception.

干预措施: Contraception information (Behavioral)

Reproductive Life Planning (RLP)

Experimental

RLP is an online adaptation of the Centers for Disease Control and Prevention (CDC) reproductive life planning toll that guides women to identify their reproductive goals and individual requirements for contraception.

干预措施: Reproductive Life Planning (RLP) (Behavioral)

Reproductive Life Planning Plus (RLP+)

Experimental

RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence.

干预措施: Reproductive Life Planning (RLP) (Behavioral)

Reproductive Life Planning Plus (RLP+)

Experimental

RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence.

干预措施: Contraceptive Action Planning (Behavioral)

Reproductive Life Planning Plus (RLP+)

Experimental

RLP+ additionally includes contraceptive action planning, aimed at helping women select solutions for potential problems they may encounter with contraceptive adherence.

干预措施: Contraception information (Behavioral)

Information-only control

Active Comparator

The information-only control will deliver on-line information about their contraceptive benefits coverage and information about all FDA-approved contraceptive methods.

干预措施: Contraception information (Behavioral)

结局指标

主要结局

Contraceptive Use

时间窗: 24 months

Percentage of surveys with any contraceptive use

次要结局

  • Effectiveness of Contraceptive Method(24 months)
  • Contraceptive Adherence(24 months)
  • Contraceptive Method Satisfaction(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cynthia Chuang

Associate Professor of Medicine and Public Health Sciences

Milton S. Hershey Medical Center

研究点 (2)

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