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"My Decision" Tool for Tubal Ligation Decisions

N/A
Waitlist Available
Led By Sonya Borrero, MD MS
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fluently speak English or Spanish
Fluently read English or Spanish
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three months postpartum (time 3)
Awards & highlights

Study Summary

This trial is testing a web tool to help low-income women make decisions about sterilization that fit their preferences, values, and goals. The goal is to see if it lowers decisional conflict and increases satisfaction with contraception.

Who is the study for?
This trial is for low-income women aged 21-45 who are pregnant, fluent in English or Spanish, considering tubal sterilization, less than 24 weeks into their pregnancy, continuing with the pregnancy and using Medicaid. Women unable to consent or interact with web content are excluded.Check my eligibility
What is being tested?
The study tests a web-based tool designed to help make informed decisions about tubal sterilization versus usual care alone. Participants will be randomly divided into two groups: one receiving the decision aid plus usual care and the other receiving only usual care.See study design
What are the potential side effects?
Since this trial involves an informational decision support tool rather than a medical intervention, there are no direct physical side effects associated with its use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fluent in English or Spanish.
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I can fluently read English or Spanish.
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I am between 21 and 45 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three months postpartum (time 3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and three months postpartum (time 3) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Participant Satisfaction with Decision Making
Other outcome measures
Tubal sterilization
Contraceptive Method Selected
Contraceptive Method(s) Used
+7 more

Side effects data

From 2016 Phase 3 trial • 300 Patients • NCT02008565
38%
Constipation
10%
Urinary tract infection
8%
Abdominal pain
8%
Fall
7%
Abdominal distension
7%
Diarrhoea
6%
Nausea
6%
Headache
6%
Back pain
3%
Upper respiratory tract infection
2%
Osteoarthritis
1%
Pulmonary embolism
1%
Anaemia
1%
Haemorrhoids
1%
Ventricular tachycardia
1%
Ankle fracture
1%
Vascular pseudoaneurysm
1%
Hyperglycaemia
1%
Transient ischaemic attack
1%
Chronic obstructive pulmonary disease
1%
Pancreatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo - Education Only
Loperamide - Education Only
Loperamide - Exercise Plus Biofeedback
Placebo - Exercise Plus Biofeedback

Trial Design

2Treatment groups
Experimental Treatment
Group I: Usual Care ArmExperimental Treatment1 Intervention
Participants will receive usual medical care.
Group II: Decision Aid ArmExperimental Treatment2 Interventions
Participants will use the web-based decision aid plus usual medical care.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoOTHER
2,493 Previous Clinical Trials
11,931,448 Total Patients Enrolled
University of PittsburghLead Sponsor
1,712 Previous Clinical Trials
16,346,061 Total Patients Enrolled
University of TennesseeOTHER
188 Previous Clinical Trials
141,291 Total Patients Enrolled

Media Library

"My Decision" tubal sterilization decision aid Clinical Trial Eligibility Overview. Trial Name: NCT04097717 — N/A
Tubal Ligation Research Study Groups: Usual Care Arm, Decision Aid Arm
Tubal Ligation Clinical Trial 2023: "My Decision" tubal sterilization decision aid Highlights & Side Effects. Trial Name: NCT04097717 — N/A
"My Decision" tubal sterilization decision aid 2023 Treatment Timeline for Medical Study. Trial Name: NCT04097717 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research program accessible to seniors as well?

"The requirements for eligibility in this trial specify that applicants must be aged 21-45. For those younger than 18 and older than 65, 27 trials are being conducted respectively."

Answered by AI

What qualifications are necessary to participate in this research?

"This medical trial is looking for 350 individuals aged 21-45, who have started a pregnancy and use Medicaid insurance. Furthermore, they must be considering tubal sterilization and the current gestation period should not exceed 24 weeks."

Answered by AI

Is there still opportunity to participate in the research project?

"Affirmative, the trial is still actively recruiting participants. Clinicaltrials.gov has a record of its posting on February 24th 2020 and subsequent update from November 9th 2022."

Answered by AI

What is the participant capacity for this experiment?

"Affirmative. As per information accessible via clinicaltrials.gov, patient recruitment is currently in progress for this medical trial which originally commenced on February 24th 2020 and was last updated November 9th 2022. 350 participants are being sought from two different sites."

Answered by AI

Who else is applying?

What site did they apply to?
University of Tennessee
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I struggle with finding a contraceptive with little side effects.
PatientReceived no prior treatments
~69 spots leftby Mar 2025