Clinical trial NCT02100124: MyNewOptions: An Online Study of Reproductive Life Planning and Contraceptive Action Planning
Official title: Reducing Unintended Pregnancies Through Reproductive Life Planning and Contraceptive Action Planning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraceptive Use
Unintended Pregnancy
Keywords: reproductive life planning
action planning
contraceptive use
unintended pregnancy
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-03-31
Enrollment: 987
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Contraceptive Use
timeFrame: 24 months
Secondary outcomes:
measure: Effectiveness of Contraceptive Method
timeFrame: 24 months
measure: Contraceptive Method Satisfaction
timeFrame: 24 months
measure: Contraceptive Adherence
timeFrame: 24 months
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State College of Medicine
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Cynthia H Chuang, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zheng A, Nelson HN, McCall-Hosenfeld JS, Lehman EB, Chuang CH. Recent Intimate Partner Violence and Oral Contraceptive Pill Adherence in a Cohort of Reproductive-Aged Women. J Womens Health (Larchmt). 2022 Dec;31(12):1703-1709. doi: 10.1089/jwh.2021.0622. Epub 2022 Sep 20.
citation: Lauring JR, Lehman EB, Deimling TA, Legro RS, Chuang CH. Combined hormonal contraception use in reproductive-age women with contraindications to estrogen use. Am J Obstet Gynecol. 2016 Sep;215(3):330.e1-7. doi: 10.1016/j.ajog.2016.03.047. Epub 2016 Apr 5.
citation: Chuang CH, Velott DL, Weisman CS, Sciamanna CN, Legro RS, Chinchilli VM, Moos MK, Francis EB, Confer LN, Lehman EB, Armitage CJ. Reducing Unintended Pregnancies Through Web-Based Reproductive Life Planning and Contraceptive Action Planning among Privately Insured Women: Study Protocol for the MyNewOptions Randomized, Controlled Trial. Womens Health Issues. 2015 Nov-Dec;25(6):641-8. doi: 10.1016/j.whi.2015.06.010. Epub 2015 Aug 22.
citation: Weisman CS, Lehman EB, Legro RS, Velott DL, Chuang CH. How do pregnancy intentions affect contraceptive choices when cost is not a factor? A study of privately insured women. Contraception. 2015 Nov;92(5):501-7. doi: 10.1016/j.contraception.2015.05.007. Epub 2015 May 19.