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

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: Terminated
• Conditions: Substance Use Disorders; Pregnancy Outcome; Prenatal Care
• Intervention / Treatment: Other: Monthly Pregnancy Screening; Other: Usual 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 Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	1.5 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	1.5 year

Collaborators and Investigators

• Sponsor: McMaster University

Publications and helpful links

General 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.
• Armstrong 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.
• Black 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.
• Sabourin 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.
• Heaman 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.
• Wong 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): October 31, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: April 3, 2018
• First Posted (Actual): April 5, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Opioid Substitution Therapy; Pregnancy Tests
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID 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