Routine Pregnancy Screening for Women on Opioid Substitution Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Women who take opioid substitution therapy have higher rates of unintended pregnancy, more pregnancies, and a higher risk of pregnancy complications than the general population. Current practice is to test for pregnancy only at patient request or if the clinician suspects pregnancy. This study will compare monthly pregnancy testing to current practice in a double blind randomized control trial. As many women of childbearing age as possible will be recruited from the Hamilton Clinic for Opioid Substitutional Therapy. Women assigned to the intervention will have monthly testing at the same time as their monthly urine drug testing at the clinic. The primary objective is to assess if there is a significant difference is early pregnancy detection and the secondary objectives are to assess differences in pregnancy disposition and gestational age at entry to prenatal or abortion care.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes

NCT03923374

Opioid-use Disorder Opioid Use, Unspecified Buprenorphine Dependence

RECRUITING

Pharmacologically-based Strategies for Opioid Substitution Therapy During Pregnancy

NCT03831113

Opiate Addiction Pregnancy

TERMINATED PHASE2

Buprenorphine vs Buprenorphine/Naloxone on the Effects of Maternal Symptomatology

NCT03740243

Opioid-use Disorder

WITHDRAWN PHASE4

Impact of Pregnancy on Buprenorphine Pharmacokinetics and Pharmacodynamics

NCT02863601

Opiate Addiction Pregnancy

COMPLETED

Maternal Buprenorphine-naloxone Treatment and the Infant

NCT03291847

Maternal Opioid Use Disorder Opioid Exposed Infant

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Substance Use Disorders Prenatal Care Pregnancy Outcome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to either standard practice or monthly pregnancy screening.

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Monthly Pregnancy Screening

Patients at the Hamilton Clinic present to the clinic most often on a weekly basis to provide a urine sample for urine drug screening and to meet with their MRP. This same urine sample will be tested for pregnancy in the intervention group once per month. Resulting positive test results will be reported to the patient through their attending physician on the day of testing.

Group Type EXPERIMENTAL

Monthly Pregnancy Screening

Intervention Type OTHER

Pregnancy test will be administered once per month during weekly urine testing for drug levels.

Usual Care

Participants in the control group will not receive study-initiated urine pregnancy testing but will receive usual care, which may include pregnancy testing based on patient request or clinical judgement.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Usual care.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Monthly Pregnancy Screening

Pregnancy test will be administered once per month during weekly urine testing for drug levels.

Intervention Type OTHER

Usual Care

Usual care.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* currently on methadone or buprenorphine maintenance therapy
* have some male sexual partners

Exclusion Criteria

* females who have exclusively female sexual partners
* a previous diagnosis of premature menopause
* hysterectomy, oophorectomy, and/or tubal ligation
* current pregnancy
* current intrauterine device (hormonal or non-hormonal)
* unable to give informed consent in English

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes