N/A
N=138
Improving Effective Contraceptive Use Among Opioid-maintained Women: Stage II
Contraceptive Usage · Opioid Dependence
Bottom Line
View on ClinicalTrials.gov: NCT02411357 ↗Enrolled (actual)
138
Serious AEs
3.6%
Results posted
Feb 2023
Primary outcome: Primary: Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment — 5; 14; 23 Participants — p=<.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Treatment as usual (Behavioral); WHO contraception protocol (Behavioral); Incentives (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Vermont
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Verified Prescription Contraceptive Use at the 6-month Assessment |
5; 14; 23 | <.001 sig |
Summary
Nearly 9 of every 10 pregnant opioid-dependent women report that the current pregnancy was unintended and the majority of non-pregnant opioid-maintained women do not use contraception or use less effective methods like condoms. This proposal aims to further test a novel contraceptive management program to increase use of more effective contraceptives among opioid-maintained women at risk of unintended pregnancy.
Eligibility Criteria
Inclusion Criteria
- 18-44 years of age
- pre-menopausal and have no history of tubal ligation or hysterectomy
- have had heterosexual vaginal sex in the past 3 months
- have no plans to become pregnant in the next 6 months
- be medically eligible to use prescription contraceptives
- report no prescription contraceptive use (i.e., no use of pill, patch, ring, implants, or IUDs in the past 7 days or injections in the past 3 months)
- be in opioid maintenance treatment
- at least 8 weeks postpartum
- not be facing imminent incarceration
- have no plans to leave the area in the next 12 months
- be English-speaking
Exclusion Criteria
- failure to meet the aforementioned inclusion criteria
- refusal to participate
Data sourced from ClinicalTrials.gov (NCT02411357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.