Substance Use DisordersPREG-ONCT03489174
Routine Pregnancy Screening for Women on Opioid Substitution Therapy
A study testing Monthly Pregnancy Screening in people with Substance Use Disorders and Prenatal Care, run by McMaster University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Substance Use Disorders, Prenatal Care, Pregnancy Outcome
- What is being tested?
- Monthly Pregnancy Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- 1 Nov 2019to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- currently on methadone or buprenorphine maintenance therapy
- have some male sexual partners
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Substance Use Disorders, Prenatal Care, Pregnancy Outcome
- Being tested
- Monthly Pregnancy Screening, Usual Care
- Keywords
- Opioid Substitution Therapy, Pregnancy Tests
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monthly Pregnancy ScreeningOther
Pregnancy test will be administered once per month during weekly urine testing for drug levels.
Usual CareOther
Usual care.
| Study group | Role | What they receive |
|---|---|---|
| Monthly Pregnancy Screening | Experimental | 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. Receives: Other: Monthly Pregnancy Screening |
| Usual Care | Active comparator | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Pregnancy Detection
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.
Measured: 1.5 year
Secondary outcomes (3)
Differences in pregnancy disposition
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.
Measured: Through study completion, an average of 1.5 year
Gestational age at entry into pregnancy-related care
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.
Measured: Through study completion, an average of 1.5 year
Cost of monthly pregnancy tests
The cost of additional pregnancy testing will be recorded by The Hamilton Clinic for OST for the length of the trial.
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2018
- Study start1 Nov 2019
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Why it stopped: Unable to recruit sufficient participants to complete study intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either standard practice or monthly pregnancy screening.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489174
- Sponsor's protocol ID
- PREG-O
- Acronym
- PREG-O
- Status last verified
- Apr 2022
- First submitted
- 5 Mar 2018
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heil SH, Jones HE, Arria A, Kaltenbach K, Coyle M, Fischer G, Stine S, Selby P, Martin PR. Unintended pregnancy in opioid-abusing women. J Subst Abuse Treat. 2011 Mar;40(2):199-202. doi: 10.1016/j.jsat.2010.08.011. Epub 2010 Oct 30.
PubMed 21036512Black AY, Guilbert E, Hassan F, Chatziheofilou I, Lowin J, Jeddi M, Filonenko A, Trussell J. The Cost of Unintended Pregnancies in Canada: Estimating Direct Cost, Role of Imperfect Adherence, and the Potential Impact of Increased Use of Long-Acting Reversible Contraceptives. J Obstet Gynaecol Can. 2015 Dec;37(12):1086-97. doi: 10.1016/s1701-2163(16)30074-3.
PubMed 26637081Armstrong KA, Kennedy MG, Kline A, Tunstall C. Reproductive health needs: comparing women at high, drug-related risk of HIV with a national sample. J Am Med Womens Assoc (1972). 1999 Spring;54(2):65-70, 78.
PubMed 10319594Sabourin JN, Burnett M. A review of therapeutic abortions and related areas of concern in Canada. J Obstet Gynaecol Can. 2012 Jun;34(6):532-542. doi: 10.1016/S1701-2163(16)35269-0.
PubMed 22673169Heaman MI, Newburn-Cook CV, Green CG, Elliott LJ, Helewa ME. Inadequate prenatal care and its association with adverse pregnancy outcomes: a comparison of indices. BMC Pregnancy Childbirth. 2008 May 1;8:15. doi: 10.1186/1471-2393-8-15.
PubMed 18452623Wong S, Ordean A, Kahan M; MATERNAL FETAL MEDICINE COMMITTEE; FAMILY PHYSICIANS ADVISORY COMMITTEE; MEDICO-LEGAL COMMITTEE; AD HOC REVIEWERS; SPECIAL CONTRIBUTORS. Substance use in pregnancy. J Obstet Gynaecol Can. 2011 Apr;33(4):367-384. doi: 10.1016/S1701-2163(16)34855-1.
PubMed 21501542
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Pregnancy Screening for Women on Opioid Substitution Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03489174
- Acronym / sponsor ID
- PREG-O / PREG-O
- Conditions
- Substance Use Disorders, Prenatal Care, Pregnancy Outcome
- Keywords
- Opioid Substitution Therapy, Pregnancy Tests
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit sufficient participants to complete study intervention
- Enrolment
- 11 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 5 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either standard practice or monthly pregnancy screening.
| Arm | Type | Receives |
|---|---|---|
| Monthly Pregnancy Screening | Experimental | Other: Monthly Pregnancy ScreeningPatients 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. |
| Usual Care | Active comparator | Other: Usual CareParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- currently on methadone or buprenorphine maintenance therapy
- have some male sexual partners
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monthly Pregnancy ScreeningPregnancy test will be administered once per month during weekly urine testing for drug levels. | Other | Monthly Pregnancy Screening |
| Usual CareUsual care. | Other | Usual Care |
Primary outcome
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.
3 secondary outcomes
Differences in pregnancy disposition
Time frame: 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
Cost of monthly pregnancy tests
Time frame: 1.5 year
Results and safety
The study was stopped early (reason given: Unable to recruit sufficient participants to complete study intervention). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Background: PubMed 21036512Heil SH, Jones HE, Arria A, Kaltenbach K, Coyle M, Fischer G, Stine S, Selby P, Martin PR. Unintended pregnancy in opioid-abusing women. J Subst Abuse Treat. 2011 Mar;40(2):199-202. doi: 10.1016/j.jsat.2010.08.011. Epub 2010 Oct 30.
- Background: PubMed 26637081Black AY, Guilbert E, Hassan F, Chatziheofilou I, Lowin J, Jeddi M, Filonenko A, Trussell J. The Cost of Unintended Pregnancies in Canada: Estimating Direct Cost, Role of Imperfect Adherence, and the Potential Impact of Increased Use of Long-Acting Reversible Contraceptives. J Obstet Gynaecol Can. 2015 Dec;37(12):1086-97. doi: 10.1016/s1701-2163(16)30074-3.
- Background: PubMed 10319594Armstrong KA, Kennedy MG, Kline A, Tunstall C. Reproductive health needs: comparing women at high, drug-related risk of HIV with a national sample. J Am Med Womens Assoc (1972). 1999 Spring;54(2):65-70, 78.
- Background: PubMed 22673169Sabourin JN, Burnett M. A review of therapeutic abortions and related areas of concern in Canada. J Obstet Gynaecol Can. 2012 Jun;34(6):532-542. doi: 10.1016/S1701-2163(16)35269-0.
- Background: PubMed 18452623Heaman MI, Newburn-Cook CV, Green CG, Elliott LJ, Helewa ME. Inadequate prenatal care and its association with adverse pregnancy outcomes: a comparison of indices. BMC Pregnancy Childbirth. 2008 May 1;8:15. doi: 10.1186/1471-2393-8-15.
- Background: PubMed 21501542Wong S, Ordean A, Kahan M; MATERNAL FETAL MEDICINE COMMITTEE; FAMILY PHYSICIANS ADVISORY COMMITTEE; MEDICO-LEGAL COMMITTEE; AD HOC REVIEWERS; SPECIAL CONTRIBUTORS. Substance use in pregnancy. J Obstet Gynaecol Can. 2011 Apr;33(4):367-384. doi: 10.1016/S1701-2163(16)34855-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monthly Pregnancy Screening in people with Substance Use Disorders and Prenatal Care, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit sufficient participants to complete study intervention). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Pregnancy Detection (time frame: 1.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03489174, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.