Clinical trial NCT03489174: Routine Pregnancy Screening for Women on Opioid Substitution Therapy
Official title: Routine Pregnancy Screening for Women on Opioid Substitution Therapy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Substance Use Disorders
Prenatal Care
Pregnancy Outcome
Keywords: Opioid Substitution Therapy
Pregnancy Tests
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 11
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either standard practice or monthly pregnancy screening.
Primary purpose: SCREENING

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Early Pregnancy Detection
timeFrame: 1.5 year
Secondary outcomes:
measure: Differences in pregnancy disposition
timeFrame: Through study completion, an average of 1.5 year
measure: Gestational age at entry into pregnancy-related care
timeFrame: Through study completion, an average of 1.5 year
measure: Cost of monthly pregnancy tests
timeFrame: 1.5 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: The Hamilton Clinic
state: Ontario
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.