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Completed

NCT Number: NCT02532946

Bedsider.Org in Post-abortion Contraceptive Counseling: A Mixed Methods Study

This is a mixed methods study, incorporating a randomized controlled trial and a qualitative provider focus group, to evaluate contraceptive counseling aided by www.Bedsider.org in patients seeking first-trimester abortion. The primary outcome is the uptake of long-acting reversible contraception in women seeking induced abortion.

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Key information

Conditions

Age range

18 year–29 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

Nearly half of pregnancies among American women are unintended, and about 4 in 10 of these are terminated by abortion. Unmet need for family planning is the cause for induced abortion, and those women seeking induced abortion are a high risk for repeat abortion. Family planning services are of paramount importance to this population, and evidence shows that high-quality family planning counseling and provision of methods prior to discharge from a care facility improve uptake and continuation of methods. In a recent study, oral contraceptive pills, a transdermal patch, or a vaginal ring had a risk of contraceptive failure that was 20 times as high as the risk among those using long-acting reversible contraception (IUD or implant).

We plan to randomize preoperative clinic days to either provider counseling aided by Bedsider.org or routine provider counseling, and compare the types of contraceptive methods that are chosen in each group, with the primary outcome being uptake of long-acting reversible contraception (intrauterine device or implant). The secondary outcome is satisfaction with contraceptive counseling in both groups.

We also plan to conduct a qualitative focus group study of provider perspectives of this counseling tool after completion of the randomized trial. Materials related to the qualitative portion of the study will be submitted in a separate amendment. No Follow-up is needed.

EXPECTED OUTCOMES AND DISSEMINATION OF FINDINGS The goal of the study is to assess the feasibility and effectiveness of using a web-based contraception tool in a unique family planning clinic serving high-risk patients with expert family planning providers. After assessing feasibility, utility, and effectiveness in our practice setting, we hope to spread the use of bedsider.org to the entirety of the outpatient clinic, which includes general obstetrics and gynecology patients and providers.

After completion of the study, we plan to submit our findings for presentation at a national meeting, and submit a manuscript for publication in a peer-reviewed journal.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • English speaking
  • Seeking medical or surgical pregnancy termination
  • 12 weeks gestation or less

Exclusion criteria

  • Early pregnancy failure
  • Medical contraindications to any contraceptive methods as based on CDC Medical Eligibility Criteria

Treatment and study plan

Bedsider.org counseling

Behavioral

Contraceptive counseling was done while women kept the computer/tablet throughout their visit to facilitate discussion of website information with their providers.

Primary outcomes

  1. Uptake, as measured by questionnaire, of long-acting reversible contraception (LARC) in 18-29 women seeking induced abortion

    Time frame: Up to 10 days

    Decision on contraceptive tool selected: LARC - Yes or No

Secondary outcomes

  1. Satisfaction with a web based tool as measured by a Likert scale

    Time frame: Up to 10 days

    Short Questionnaire with likeret scale

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Acronym: Bedsider

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 26, 2015
Registry last updated
Apr 13, 2017

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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