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

Contraception Clinical Trial

— Bedsider  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02532946
• Other study ID #: H-31382
• Status: Completed
• Phase: N/A
• First received: March 9, 2015
• Last updated: April 12, 2017
• Start date: August 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2017
• Source: Boston Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake, as measured by questionnaire, of long-acting reversible contraception (LARC) in 18-29 women seeking induced abortion	Decision on contraceptive tool selected: LARC - Yes or No	Up to 10 days
Secondary	Satisfaction with a web based tool as measured by a Likert scale	Short Questionnaire with likeret scale	Up to 10 days

External Links

•   Bedsider site