Routine Pregnancy Screening for Women on Opioid Substitution Therapy

NCT03489174 | Terminated

• 1 other identifier: PREG-O
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Substance Use Disorders; Prenatal Care; Pregnancy Outcome

Keywords

Opioid Substitution Therapy; Pregnancy Tests

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Differences in pregnancy disposition

  Through study completion, an average of 1.5 year

• Gestational age at entry into pregnancy-related care

  Through study completion, an average of 1.5 year

• Cost of monthly pregnancy tests

  1.5 year

Study Arms (2)

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.

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.

Other: Usual Care

Interventions

Monthly Pregnancy Screening OTHER

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

Monthly Pregnancy Screening

Usual Care OTHER

Usual care.

Usual Care

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

The Hamilton Clinic

Hamilton, Ontario, L8N 1H3, Canada

Location

Related Publications (6)

• 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.

  PMID: 21036512 BACKGROUND

• 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.

  PMID: 26637081 BACKGROUND

• 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.

  PMID: 10319594 BACKGROUND

• 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.

  PMID: 22673169 BACKGROUND

• 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.

  PMID: 18452623 BACKGROUND

• 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.

  PMID: 21501542 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: April 5, 2018
• Study Start: November 1, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

CA (1)