Routine Pregnancy Screening for Women on Opioid Substitution Therapy
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pregnancy Outcome
- Prenatal Care
- Substance Use Disorders
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Participants will be randomly assigned to either standard practice or monthly pregnancy screening.Masking: Double (Participant, Investigator)Masking Description: Participants will not know if they are assigned to the intervention or control group. Their weekly urine test that is collected by the opioid substitution therapy clinic will be tested monthly for pregnancy. Pregnancy will then be reported to the patient's attending physician on the day of testing, who would then communicate the result to the patient. The physician will continue with standard pregnancy care. The investigators will remain blind throughout data analysis and will not know if the pregnancy was discovered via monthly testing or standard practice.Primary Purpose: Screening
Participation Requirements
- Age
- Between 18 years and 40 years
- Gender
- Only males
Description
The Routine Pregnancy Screening in Women on Opioid Substitutional Therapy study involves screening women from the The Hamilton Clinic for OST regularly for pregnancy to determine if this results in earlier prenatal care and improved pregnancy disposition. All eligible women at the Hamilton clinic wi...
The Routine Pregnancy Screening in Women on Opioid Substitutional Therapy study involves screening women from the The Hamilton Clinic for OST regularly for pregnancy to determine if this results in earlier prenatal care and improved pregnancy disposition. All eligible women at the Hamilton clinic will be approached for recruitment. The study phase last for 18 months. The investigators will assess for any significant difference in the rates of early pregnancy diagnosis, pregnancy disposition, and associated outcome measurements. Study results could inform best practices in the care of child-bearing women on OST and will provide baseline information and feasibility data to inform design of a larger RCT to assess the effect on pregnancy and birth outcomes. This pilot study will serve to demonstrate whether routine pregnancy screening is effective for earlier pregnancy diagnosis and whether it has any impact on pregnancy disposition and entry into pregnancy-related care for women on OST. In addition, the investigators will also be seeking to address whether routine pregnancy testing is logistically and financially feasible for patients receiving OST at a primary care-run addiction setting. If this intervention is found to be both effective and feasible, it would be possible to apply this study methodology to larger-scale RCTs across multiple clinical sites with the power to assess maternal and fetal outcomes.
Tracking Information
- NCT #
- NCT03489174
- Collaborators
- Not Provided
- Investigators
- Not Provided
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