Routine Pregnancy Screening for Women on Opioid Substitution Therapy (PREG-O)

April 12, 2022 updated by: McMaster University

Routine Pregnancy Screening for Women on Opioid Substitution Therapy: A Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 1H3
        • The Hamilton Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Other: Monthly Pregnancy Screening
Pregnancy test will be administered once per month during weekly urine testing for drug levels.
Active Comparator: 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.
Other: Usual Care
Usual care.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Early Pregnancy Detection
Time Frame: 1.5 year
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 can be tested for pregnancy in the intervention group once per month. Positive pregnancy test rates will be recorded for the intervention and control groups over the 1 year study period.
1.5 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Differences in pregnancy disposition
Time Frame: Through study completion, an average of 1.5 year
Pregnancy disposition will be measured by the woman's choice to either continue with the pregnancy and enter care or enter into induced abortion care. Participants will either give the researchers access to their medical records and outcomes will be recorded from that information or participants can complete a self-report on pregnancy outcomes.
Through study completion, an average of 1.5 year
Gestational age at entry into pregnancy-related care
Time Frame: Through study completion, an average of 1.5 year
Gestational age at entry into pregnancy related care will be obtained from ultrasounds and/or dates estimated from last menstrual period if access is granted to medical records. Otherwise researchers will depend on self-report. Pregnancy related care includes prenatal care or induced abortion services.
Through study completion, an average of 1.5 year
Cost of monthly pregnancy tests
Time Frame: 1.5 year
The cost of additional pregnancy testing will be recorded by The Hamilton Clinic for OST for the length of the trial.
1.5 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PREG-O

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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