Opioid-Related DisordersMORENCT04251208

MOms in REcovery (MORE) Study: Defining Optimal Care

An observational study of Opioid-Related Disorders and NAS, run by Trustees of Dartmouth College at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 to 50 years, women only
Conditions the study is for: Opioid-Related Disorders, NAS, Substance Use Disorders
What is being tested?: Observational Study
How many people: 2,510 participants
Where: 10 sitesUnited States
Study dates: 30 Jul 2019to 31 Jan 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 16 to 50 years
Women only
No healthy volunteers
Child, Adult

Study population: Aim 1. Retrospective records from eligible women who delivered in specified time period in one of our 26 partner practices will be reviewed for specified clinical outcomes. Aim 2. Participants will be recruited from our 26 partner maternity care practices located throughout our northeastern New England region: New Hampshire, Maine, and Vermont.

Who may be able to join

Age 16 year and older,
Identified opioid use disorder,
Receiving prenatal care for current pregnancy at partner practice,
Clinic-recorded diagnosis of opioid use disorder,
Willing and able to provide informed consent.

Who cannot join

Ward of the State

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Maine General Hospital
Augusta, Maine, 04330
Eastern Maine Medical Center/Northern Light
Bangor, Maine, 04401
Southwestern Vermont Medical Center OB-GYN
Bennington, Vermont, 05201
Central Vermont Medical Center
Berlin Corners, Vermont, 05602
Brattleboro Memorial Hospital OB-GYN
Brattleboro, Vermont, 05301
Dartmouth Hitchcock Keene/Cheshire Medical Center OB-GYN
Keene, New Hampshire, 03431
Dartmouth-Hitchcock Medical Center-OB/GYN
Lebanon, New Hampshire, 03756
Dartmouth Hitchcock Addiction Treatment, Moms in Recovery
Lebanon, New Hampshire, 03766
Dartmouth Hitchcock Bedford/Manchester
Manchester, New Hampshire, 03101
Dartmouth Hitchcock Nashua OB-GYN
Nashua, New Hampshire, 03060

Other trials in United States

About this study

Official title: MOms in REcovery (MORE): Defining Optimal Care for Pregnant Women and Infants

Northern New England has among the highest rates of opioid dependence in the U.S. This region also has among the highest rates of opioid-related deaths in the U.S., with a disproportionate high rate among pregnant women with opioid use disorder. Newborns impacted by OUD have increased risk of poor outcomes, including preterm birth and long hospitalization for neonatal withdrawal and other newborn complications. For pregnant women with OUD, medication treatment (MOUD) significantly reduces these risks. Many maternity care providers have begun to prescribe MOUD in their practices. Other practices have maintained the longstanding evidence-based standard of care, referral of patients with OUD to specialty treatment programs. Most pregnant women with OUD have other psychosocial needs, ranging from lack of housing and untreated mental health conditions, to need for parenting education and support. There is variability among practices in terms of types of other services provided to patients. Although pregnancy is a time when women are highly motivated to start MOUD, many women are also likely to discontinue MOUD postpartum due to loss of insurance coverage, difficulty transitioning to another provider, loss of motivation for treatment, or competing demands on time and resources as a new parent.

The challenge for patients, providers, and other stakeholders is to understand the relative advantage of the two MOUD models (receiving MOUD as part of maternity care or at a specialty program) for improving key outcomes for baby \& mother. A second challenge is to understand the relative contributions of onsite services such as mental health care, care coordination and parenting education to improved outcomes. Addressing these challenges is particularly important in rural areas where obstetric practices \& specialty care services are limited. Patients, providers \& other stakeholders need guidance in choosing the optimal models for building programs to provide maternity care for women with OUD.

Read the detailed description

Northern New England has among the highest rates of opioid dependence in the U.S, with prevalence highest and growing among those aged 18-35 years. Regional rates of perinatal opioid use disorders (OUD) reflect this public health crisis; Northern New England region has the highest incidence of opioid-related births in the nation. Perinatal opioid use disorders impact 5-8% of pregnancies in Maine, New Hampshire, and Vermont, three states that have been severely impacted by the current opioid epidemic. Consequences of inadequately treated OUD include premature delivery and other perinatal complications, prolonged newborn hospitalization for neonatal abstinence (NAS), and maternal morbidity and mortality from infectious disease and overdose. In 2013, costs associated with NAS treatment in the U.S. reached $1.5 billion. The epidemic has grown multifold since 2013.

Medication assisted treatment (MAT) with either methadone or buprenorphine is the recommended standard of care during pregnancy. Professionals, including the American College of Obstetricians and Gynecologists (ACOG), the American Academy of Pediatrics, the Society for Maternal-Fetal Medicine, and the American Society for Addiction Medicine, have called to adopt care models that promote early identification and treatment for pregnant women with OUD. Referral to specialty programs for MAT has been the accepted standard of care, with demonstrated safety for women and their infants. However, in response to the escalating opioid crisis, the ACOG began offering buprenorphine training programs to its members. Consequently, a number of maternity care practices throughout Northern New England now provide integrated MAT services. But even where such integrated programs exist, questions persist on the optimal care model for providing MAT to pregnant women with OUD.

There are patient- and provider- factors associated with variability in effectiveness of what MAT model works best for whom. For women, advantages of buprenorphine over methadone include a lower risk of overdose, fewer drug interactions, the accessibility of office-based treatment delivery in the context of maternity care and demonstrated shorter NAS course. The disadvantages of buprenorphine relative to methadone include potential hepatic dysfunction, lack of long-term data on consequences of fetal exposure for infants, potential limited efficacy in patients with high addiction severity, requirement of moderate withdrawal symptoms prior to initiation to avoid iatrogenic withdrawal, and an increased risk of diversion (i.e., sharing or sale). Despite buprenorphine's demonstrated neonatal advantages, it is not effective for all women. The structure of methadone treatment (daily meeting) may also better align with support needs for some women. For providers, the choice of what medication-assisted approach to offer to patients is often restricted by availability and access to specialty care services.

There is limited literature comparing the effectiveness of integrated versus referral MAT care models for postpartum retention in treatment and women's experiences in these two models. In particular, women with high levels of addiction severity or co-occurring mental health conditions may have prenatal care needs from women with less complex behavioral health concerns. Studies have also not assessed the impact of maternal opioid addiction severity on newborn outcomes and maternal long-term recovery. The best neonatal outcomes will be achieved by providing the most appropriate and effective treatment for mothers.

The challenge for patients, providers, and other stakeholders is determining the optimal approach for delivering MAT during pregnancy and after delivery to improve outcomes. Currently, regional obstetrical practices provide either: (1) Integrated care, in which MAT and associated psychosocial services are delivered on site with obstetrical care, and (2) Referral-based care, in which women receive MAT and obstetrical care in separate, specialized locations. Both models have different potential advantages and disadvantages for mothers with OUD and their babies regarding access, availability, acceptability and quality of MAT, obstetrics and other needed services, and long term follow up and treatment after delivery. While pregnancy motivates women to initiate MAT, relapse to use of opioids and cessation of MAT frequently occur during the first postpartum year, placing both mother and infant at significant risk. Payers and policymakers are also seeking answers about where to invest healthcare resources to increase access to treatment for pregnant women, especially in the current opioid crisis. A disproportionate number of women with OUD are insured through the Medicaid system; Medicaid policy affects women's access to a wide range of services, from reimbursement for same-day services or care coordination, to whether a woman continues to be eligible for benefits after delivery.

Study Aims: The primary aims of this study seek to answer these important patient, provider, and policy questions by comparing the real-world effectiveness of two models of MAT delivery currently in clinical use in Maine, New Hampshire, and Vermont with respect to patient experience of care and perinatal, neonatal, and longer-term substance use treatment outcomes. The following main Comparative Effectiveness Research (CER) Patient-Centered Outcomes Research Institute (PCORI) priority questions will be addressed:

(1) Do clinical and patient-reported outcomes for pregnant and parenting women differ between integrated and referral-based MAT practice models?

To answer this question, the following Primary Specific Aims will be addressed:

Aim 1 (Clinical Outcomes Retrospective). To use clinical record data to evaluate the comparative effectiveness of Integrated and Referral-Based MAT care models on maternal and neonatal outcomes.

Aim 2 (Patient-reported Outcomes Prospective). To use patient reported data to evaluate the comparative effectiveness of Integrated and Referral -Based care models on patient-centered outcomes.

Study Description: This study will collaboratively engage 26 practices providing maternity care across Northern New England, with examples of both integrated care and referral-based models. The study population is pregnant women who receive prenatal care from any of these practices and who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for an opioid use disorder. A cluster-based observational mixed-methods design will be used to compare outcomes for pregnant women with opioid use disorder receiving prenatal care in obstetric practices that offer MAT through one of two delivery models: Integrated or Referral-based. Retrospective clinical records data (n=2000) from pregnant women with OUD receiving prenatal care at a partner practice will be used to examine Aim 1. Aim 2 will be addressed with a patient-report subsample cohort (n=532) recruited in the 3rd trimester of care and followed to 6 months postpartum via self-report online surveys. The analytic strategy will account for clustering and patient baseline differences to compare outcomes across arms.

Conditions: Opioid-Related Disorders, NAS, Substance Use Disorders, Mental Health
Being tested: Observational Study
Keywords: Pregnancy, Infant, Newborn, Buprenorphine, Methadone, Opiate Substitution Treatment, Comparative Effectiveness, Integrated Care, Referral-based Care, Postpartum, Mental health
Medical subject headings: Opioid-Related Disorders, Substance-Related Disorders, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Observational StudyOther
No intervention will be administered.

Study groups in NCT04251208
Study group	Role	What they receive
Integrated Care		This is an observational study and no intervention will be administered. The Integrated Cohort consists of pregnant women with identified opioid use disorder who are receiving prenatal care in a maternity setting that provides medication assisted treatment for opioid use. Receives: Other: Observational Study
Referral-Based Care		This is an observational study and no intervention will be administered. The Referral-Based Cohort consists of pregnant women with identified opioid use disorder who are receiving prenatal care in a maternity setting and are referred to substance use treatment at a specialty care setting. Receives: Other: Observational Study

What is being measured

The primary outcome is the main question the study is designed to answer.

Self Report of Medication Treatment for Opioid Use Disorder at 6 Months Postpartum (Yes)
Portion of participants who self reported receiving MOUD (yes) at 6 months postpartum.
Measured: measured 3rd trimester, 3 months postpartum, 6 months postpartum (reported 6 months postpartum)
Number of Participants With High Self Reported Depression Symptoms (Moderate to Severe) From Baseline to 6 Months Postpartum
- Full unabbreviated scale name: Edinburgh Postnatal Depression Scale
- Maximum and minimum scores: 0-30, higher indicates more severe symptoms
- Scoring and interpretation of values: Binary variable (0/1) was created based on established cutoffs: <=14 = 0 low symptoms/>14=1 moderate to high symptoms
Measured: assessed at 3rd trimester, 3 months postpartum and 6 months postpartum (reported 6 months postpartum)
Change in Number of Participants That Self Reported Anxiety: Moderate to Severe From Baseline to 6 Months Postpartum
- Full unabbreviated scale name: Generalized Anxiety Disorders Scale- 7
- Maximum and minimum scores: 0-21, higher indicates more severe symptoms
- Scoring and interpretation of values: 7-item scale with each item scored from 0 (not at all) to 3 (nearly every day), results are summed to calculate overall score. Score >=10 is considered clinically significant anxiety symptomatology: https://www.mdcalc.com/gad-7-general-anxiety-disorder-7 Binary variables were created for analyses: < =9 = 0 Low; >9 = 1 High
Measured: Assessed at 3rd trimester, 3 months postpartum and 6 months postpartum (reported 6 months postpartum).
Self Reported Prenatal Care Experience
Instrument: Experience of Care module of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Clinician and Groups Survey, 28 items measured on 1-5 Likert, high scores indicative of more positive perceptions. A total score was created by averaging the items on the 5-point response scale, with high scores indicative of more positive patient-centered care perceptions. (range: 1-5).
Measured: 3rd Trimester
Medication Treatment for Opioid Use Disorder Yes at Delivery
Retrospective Cohort: Medical record indication of medication for opioid use disorder as noted in medication list or notes at delivery
Measured: Single Point - Delivery
Non-prescribed Opioid Use at Delivery (Yes)
Retrospective: Indicator of non-prescribed opioid use at delivery as indicated by positive drug screen at delivery or problem notes.
Measured: Single Timepoint: Delivery
Perinatal Complications (Yes)
Indications of perinatal complications as indicated by any of the following in the antenatal period: pre-eclampsia, fetal growth <10% intrauterine growth restriction. miscarriage, fetal demise, bleeding, placental abruption, deep vein thrombosis
Measured: Single Point, at Delivery

Secondary outcomes (8)

Change in Self Reported Physical Quality of Life From 3rd Trimester to 6 Months Postpartum
Quality of Life was assessed with the 28-item WHOQOL Bref, a well-established and frequently used instrument in health services research, including with substance use affected populations.33,34 Items reflect 4 domains: Physical (7 items), Psychological (6 items), Social (3 items), Environment (8 items). Individual QOL domain scores were created per the scoring protocol (range: 0-100), with higher scores indicating greater perceived quality of life in that area.
Measured: Assessed 3rd trimester, 3 months postpartum, 6 months postpartum (6 months postpartum reported)
Change in Self Report Psychological Quality of Life From 3rd Trimester to 6 Months Postpartum
Quality of Life was assessed with the 28-item WHOQOL Bref, a well-established and frequently used instrument in health services research, including with substance use affected populations. Items reflect 4 domains: Physical (7 items), Psychological (6 items), Social (3 items), Environment (8 items). Individual QOL domain scores were created per the scoring protocol (range: 0-100), with higher scores indicating greater perceived quality of life in that area.
Measured: Assessed 3rd trimester, 3 months postpartum, 6 months postpartum (6 months postpartum reported)
Change in Self Reported Social Quality of Life From 3rd Trimester to 6 Months Postpartum
Quality of Life was assessed with the 28-item WHOQOL Bref, a well-established and frequently used instrument in health services research, including with substance use affected populations.33,34 Items reflect 4 domains: Physical (7 items), Psychological (6 items), Social (3 items), Environment (8 items). Individual QOL domain scores were created per the scoring protocol (range: 0-100), with higher scores indicating greater perceived quality of life in that area.
Measured: 3rd trimester, 3 months postpartum, 6 months postpartum (6 months reported)
Self-reported Retention of Child Custody Retention - Yes Responses
Self-reported Retention of Child Custody (yes/no) at 6 months postpartum
Measured: at 6 months postpartum
Self-report Recommended Pediatric Visits Yes at 6 Months
Self-report Recommended Pediatric Visits at 6 months (Yes)
Measured: at 6 months postpartum
Substance Use Other Than Opioid Use at Delivery(Yes)
Indication of use by positive drug screen at delivery of any of the following at delivery:
Measured: Single timepoint, delivery
Neonatal Complications (Yes)
Indication of any neonatal complications as identified in record by birth weight <=2500 gm, Apgar<7 at 5 mins, Apgar <7 at 10 mins, complications not related to neonatal opioid withdrawal syndrome (NOWS), or other noted medical problems in record.
Measured: Single point measured at delivery
Receipt of Treatment for Neonatal Opioid Withdrawal Syndrome After Delivery (Yes)
Indication of newborn treated with pharmacological agent due to withdrawal symptoms at indicated in record.
Measured: single time, within 2 weeks of delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 201931 Jan 2024

First posted31 Jan 2020
Study start30 Jul 2019
Primary completion31 Jan 2024
Study completion31 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (81)Papers the sponsor has linked to this study.
Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 2,510 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04251208
Sponsor's protocol ID: 00031444
Acronym: MORE
Status last verified: Jul 2026
First submitted: 30 Nov 2018
Last updated: 23 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ko JY, Patrick SW, Tong VT, Patel R, Lind JN, Barfield WD. Incidence of Neonatal Abstinence Syndrome - 28 States, 1999-2013. MMWR Morb Mortal Wkly Rep. 2016 Aug 12;65(31):799-802. doi: 10.15585/mmwr.mm6531a2.
PubMed 27513154
Patrick SW, Schiff DM; COMMITTEE ON SUBSTANCE USE AND PREVENTION. A Public Health Response to Opioid Use in Pregnancy. Pediatrics. 2017 Mar;139(3):e20164070. doi: 10.1542/peds.2016-4070. Epub 2017 Feb 20.
PubMed 28219965
Jones HE. Treating opioid use disorders during pregnancy: historical, current, and future directions. Subst Abus. 2013;34(2):89-91. doi: 10.1080/08897077.2012.752779.
PubMed 23577898
Jones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG, Arria AM, O'Grady KE, Selby P, Martin PR, Fischer G. Neonatal abstinence syndrome after methadone or buprenorphine exposure. N Engl J Med. 2010 Dec 9;363(24):2320-31. doi: 10.1056/NEJMoa1005359.
PubMed 21142534
Reddy UM, Davis JM, Ren Z, Greene MF; Opioid Use in Pregnancy, Neonatal Abstinence Syndrome, and Childhood Outcomes Workshop Invited Speakers. Opioid Use in Pregnancy, Neonatal Abstinence Syndrome, and Childhood Outcomes: Executive Summary of a Joint Workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, American College of Obstetricians and Gynecologists, American Academy of Pediatrics, Society for Maternal-Fetal Medicine, Centers for Disease Control and Prevention, and the March of Dimes Foundation. Obstet Gynecol. 2017 Jul;130(1):10-28. doi: 10.1097/AOG.0000000000002054.
PubMed 28594753
Jones CM, Campopiano M, Baldwin G, McCance-Katz E. National and State Treatment Need and Capacity for Opioid Agonist Medication-Assisted Treatment. Am J Public Health. 2015 Aug;105(8):e55-63. doi: 10.2105/AJPH.2015.302664. Epub 2015 Jun 11.
PubMed 26066931
Milligan K, Niccols A, Sword W, Thabane L, Henderson J, Smith A, Liu J. Maternal substance use and integrated treatment programs for women with substance abuse issues and their children: a meta-analysis. Subst Abuse Treat Prev Policy. 2010 Sep 1;5:21. doi: 10.1186/1747-597X-5-21.
PubMed 20809957
Wilder C, Lewis D, Winhusen T. Medication assisted treatment discontinuation in pregnant and postpartum women with opioid use disorder. Drug Alcohol Depend. 2015 Apr 1;149:225-31. doi: 10.1016/j.drugalcdep.2015.02.012. Epub 2015 Feb 19.
PubMed 25735465
Flavin J. (2002) A Glass Half Full? Harm reduction amongpregnant women who use cocaine. Journal of Drug Issues, 32(3):973-998. https://journals.sagepub.com/doi/10.1177/002204260203200315
Roberts SC, Nuru-Jeter A. Women's perspectives on screening for alcohol and drug use in prenatal care. Womens Health Issues. 2010 May-Jun;20(3):193-200. doi: 10.1016/j.whi.2010.02.003.
PubMed 20457407
Wright TE, Schuetter R, Fombonne E, Stephenson J, Haning WF 3rd. Implementation and evaluation of a harm-reduction model for clinical care of substance using pregnant women. Harm Reduct J. 2012 Jan 19;9:5. doi: 10.1186/1477-7517-9-5.
PubMed 22260315
Jones HE, Heil SH, Baewert A, Arria AM, Kaltenbach K, Martin PR, Coyle MG, Selby P, Stine SM, Fischer G. Buprenorphine treatment of opioid-dependent pregnant women: a comprehensive review. Addiction. 2012 Nov;107 Suppl 1(0 1):5-27. doi: 10.1111/j.1360-0443.2012.04035.x.
PubMed 23106923
Roberts SC, Pies C. Complex calculations: how drug use during pregnancy becomes a barrier to prenatal care. Matern Child Health J. 2011 Apr;15(3):333-41. doi: 10.1007/s10995-010-0594-7.
PubMed 20232126
Terplan M, Kennedy-Hendricks A, Chisolm MS. Prenatal Substance Use: Exploring Assumptions of Maternal Unfitness. Subst Abuse. 2015 Sep 20;9(Suppl 2):1-4. doi: 10.4137/SART.S23328. eCollection 2015.
PubMed 26448685
Thomas CP, Fullerton CA, Kim M, Montejano L, Lyman DR, Dougherty RH, Daniels AS, Ghose SS, Delphin-Rittmon ME. Medication-assisted treatment with buprenorphine: assessing the evidence. Psychiatr Serv. 2014 Feb 1;65(2):158-70. doi: 10.1176/appi.ps.201300256.
PubMed 24247147

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MOms in REcovery (MORE): Defining Optimal Care for Pregnant Women and Infants
ClinicalTrials.gov ID: NCT04251208
Acronym / sponsor ID: MORE / 00031444
Conditions: Opioid-Related Disorders, NAS, Substance Use Disorders, Mental Health
Keywords: Pregnancy, Infant, Newborn, Buprenorphine, Methadone, Opiate Substitution Treatment, Comparative Effectiveness, Integrated Care, Referral-based Care
Study type: Observational
Recruitment status: Completed
Enrolment: 2,510 participants (actual)
Lead sponsor: Trustees of Dartmouth CollegeUniversity, hospital or other
Collaborators: Patient-Centered Outcomes Research Institute
Study start: 30 Jul 2019 (actual)
Primary completion: 31 Jan 2024 (actual)
Study completion: 31 Jan 2024 (actual)
First posted: 31 Jan 2020 (actual)
Results: Posted 23 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

(1) Do clinical and patient-reported outcomes for pregnant and parenting women differ between integrated and referral-based MAT practice models?

To answer this question, the following Primary Specific Aims will be addressed:

Aim 1 (Clinical Outcomes Retrospective). To use clinical record data to evaluate the comparative effectiveness of Integrated and Referral-Based MAT care models on maternal and neonatal outcomes.

Aim 2 (Patient-reported Outcomes Prospective). To use patient reported data to evaluate the comparative effectiveness of Integrated and Referral -Based care models on patient-centered outcomes.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Integrated Care	–	Other: Observational StudyThis is an observational study and no intervention will be administered. The Integrated Cohort consists of pregnant women with identified opioid use disorder who are receiving prenatal care in a maternity setting that provides medication assisted treatment for opioid use.
Referral-Based Care	–	Other: Observational StudyThis is an observational study and no intervention will be administered. The Referral-Based Cohort consists of pregnant women with identified opioid use disorder who are receiving prenatal care in a maternity setting and are referred to substance use treatment at a specialty care setting.

Who may qualify

Ages: 16 to 50 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult
Study population: Aim 1. Retrospective records from eligible women who delivered in specified time period in one of our 26 partner practices will be reviewed for specified clinical outcomes. Aim 2. Participants will be recruited from our 26 partner maternity care practices located throughout our northeastern New England region: New Hampshire, Maine, and Vermont.

Key inclusion criteria (5 listed)

Age 16 year and older,
Identified opioid use disorder,
Receiving prenatal care for current pregnancy at partner practice,
Clinic-recorded diagnosis of opioid use disorder,
Willing and able to provide informed consent.

Key exclusion criteria (1 listed)

Ward of the State

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
Observational StudyNo intervention will be administered.	Other	Integrated Care, Referral-Based Care

Primary outcome

Self Report of Medication Treatment for Opioid Use Disorder at 6 Months Postpartum (Yes)
Time frame: measured 3rd trimester, 3 months postpartum, 6 months postpartum (reported 6 months postpartum)
Portion of participants who self reported receiving MOUD (yes) at 6 months postpartum.
Number of Participants With High Self Reported Depression Symptoms (Moderate to Severe) From Baseline to 6 Months Postpartum
Time frame: assessed at 3rd trimester, 3 months postpartum and 6 months postpartum (reported 6 months postpartum)
* Full unabbreviated scale name: Edinburgh Postnatal Depression Scale * Maximum and minimum scores: 0-30, higher indicates more severe symptoms * Scoring and interpretation of values: Binary variable (0/1) was created based on established cutoffs: <=14 = 0 low symptoms/>14=1 moderate to high symptoms
Change in Number of Participants That Self Reported Anxiety: Moderate to Severe From Baseline to 6 Months Postpartum
Time frame: Assessed at 3rd trimester, 3 months postpartum and 6 months postpartum (reported 6 months postpartum).
* Full unabbreviated scale name: Generalized Anxiety Disorders Scale- 7 * Maximum and minimum scores: 0-21, higher indicates more severe symptoms * Scoring and interpretation of values: 7-item scale with each item scored from 0 (not at all) to 3 (nearly every day), results are summed to calculate overall score. Score >=10 is considered clinically significant anxiety symptomatology: https://www.mdcalc.com/gad-7-general-anxiety-disorder-7 Binary variables were created for analyses: < =9 = 0 Low; >9 = 1 High
Self Reported Prenatal Care Experience
Time frame: 3rd Trimester
Instrument: Experience of Care module of the Consumer Assessment of Healthcare Providers and Systems (CAHPS) Clinician and Groups Survey, 28 items measured on 1-5 Likert, high scores indicative of more positive perceptions. A total score was created by averaging the items on the 5-point response scale, with high scores indicative of more positive patient-centered care perceptions. (range: 1-5).
Medication Treatment for Opioid Use Disorder Yes at Delivery
Time frame: Single Point - Delivery
Retrospective Cohort: Medical record indication of medication for opioid use disorder as noted in medication list or notes at delivery
Non-prescribed Opioid Use at Delivery (Yes)
Time frame: Single Timepoint: Delivery
Retrospective: Indicator of non-prescribed opioid use at delivery as indicated by positive drug screen at delivery or problem notes.
Perinatal Complications (Yes)
Time frame: Single Point, at Delivery
Indications of perinatal complications as indicated by any of the following in the antenatal period: pre-eclampsia, fetal growth <10% intrauterine growth restriction. miscarriage, fetal demise, bleeding, placental abruption, deep vein thrombosis

8 secondary outcomes

Change in Self Reported Physical Quality of Life From 3rd Trimester to 6 Months Postpartum
Time frame: Assessed 3rd trimester, 3 months postpartum, 6 months postpartum (6 months postpartum reported)
Change in Self Report Psychological Quality of Life From 3rd Trimester to 6 Months Postpartum
Time frame: Assessed 3rd trimester, 3 months postpartum, 6 months postpartum (6 months postpartum reported)
Change in Self Reported Social Quality of Life From 3rd Trimester to 6 Months Postpartum
Time frame: 3rd trimester, 3 months postpartum, 6 months postpartum (6 months reported)
Self-reported Retention of Child Custody Retention - Yes Responses
Time frame: at 6 months postpartum
Self-report Recommended Pediatric Visits Yes at 6 Months
Time frame: at 6 months postpartum
Substance Use Other Than Opioid Use at Delivery(Yes)
Time frame: Single timepoint, delivery
Neonatal Complications (Yes)
Time frame: Single point measured at delivery
Receipt of Treatment for Neonatal Opioid Withdrawal Syndrome After Delivery (Yes)
Time frame: single time, within 2 weeks of delivery

Results and safety

Results posted to the registry on 23 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Integrated Care	254	183
Referral-Based Care	186	150

Primary outcome: Self Report of Medication Treatment for Opioid Use Disorder at 6 Months Postpartum (Yes)

Time frame: measured 3rd trimester, 3 months postpartum, 6 months postpartum (reported 6 months postpartum). Count of participants. Unit: Participants

Measure	Integrated Care n = 164	Referral-Based Care n = 147
Value	122	122

Integrated Care vs Referral-Based Care: Odds Ratio (OR): .73 (95% CI .55 to .97), p = .03, generalized estimating equations (GEE)

Population analysed: analysis sample lower than baseline due to missing information and attrition over time.

Primary outcome: Number of Participants With High Self Reported Depression Symptoms (Moderate to Severe) From Baseline to 6 Months Postpartum

Time frame: assessed at 3rd trimester, 3 months postpartum and 6 months postpartum (reported 6 months postpartum). Count of participants. Unit: Participants

Measure	Integrated Care n = 164	Referral-Based Care n = 133
Value	65	58

Integrated Care vs Referral-Based Care: Odds Ratio (OR): .82 (95% CI .55 to 1.22), p = .33, Mixed Models Analysis

Population analysed: Analyses conducted with available complete data.

Primary outcome: Change in Number of Participants That Self Reported Anxiety: Moderate to Severe From Baseline to 6 Months Postpartum

Time frame: Assessed at 3rd trimester, 3 months postpartum and 6 months postpartum (reported 6 months postpartum).. Count of participants. Unit: Participants

Measure	Integrated Care n = 147	Referral-Based Care n = 124
Value	49	41

Integrated Care vs Referral-Based Care: Odds Ratio (OR): .65 (95% CI .43 to .97), p = .04, Mixed Models Analysis

Population analysed: analyses conducted on available complete data.

Primary outcome: Self Reported Prenatal Care Experience

Time frame: 3rd Trimester. Mean (Standard Deviation). Unit: score on a scale

Measure	Integrated Care n = 206	Referral-Based Care n = 156
Value	3.64 (.57)	3.61 (.56)

Integrated Care vs Referral-Based Care: Mean Difference (Final Values): -.09 (95% CI -.21 to .03), p = .14, Mixed Models Analysis

Population analysed: Analysis on available data.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Three years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Integrated Care	0 of 254 (0%)	0 of 254 (0%)	0 of 254
Referral-Based Care	0 of 186 (0%)	0 of 186 (0%)	0 of 186
Retrospective: Integrated	0 of 0	0 of 0	0
Retrospective: Referral	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): This study launched as the COVID pandemic shutdown took place resulting in considerable challenges with recruitment that required passion, creativity and flexibility to expand recruitment strategies in effort to meet recruitment and power goals.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27513154Ko JY, Patrick SW, Tong VT, Patel R, Lind JN, Barfield WD. Incidence of Neonatal Abstinence Syndrome - 28 States, 1999-2013. MMWR Morb Mortal Wkly Rep. 2016 Aug 12;65(31):799-802. doi: 10.15585/mmwr.mm6531a2.
Background: PubMed 28219965Patrick SW, Schiff DM; COMMITTEE ON SUBSTANCE USE AND PREVENTION. A Public Health Response to Opioid Use in Pregnancy. Pediatrics. 2017 Mar;139(3):e20164070. doi: 10.1542/peds.2016-4070. Epub 2017 Feb 20.
Background: PubMed 23577898Jones HE. Treating opioid use disorders during pregnancy: historical, current, and future directions. Subst Abus. 2013;34(2):89-91. doi: 10.1080/08897077.2012.752779.
Background: PubMed 21142534Jones HE, Kaltenbach K, Heil SH, Stine SM, Coyle MG, Arria AM, O'Grady KE, Selby P, Martin PR, Fischer G. Neonatal abstinence syndrome after methadone or buprenorphine exposure. N Engl J Med. 2010 Dec 9;363(24):2320-31. doi: 10.1056/NEJMoa1005359.
Background: PubMed 28594753Reddy UM, Davis JM, Ren Z, Greene MF; Opioid Use in Pregnancy, Neonatal Abstinence Syndrome, and Childhood Outcomes Workshop Invited Speakers. Opioid Use in Pregnancy, Neonatal Abstinence Syndrome, and Childhood Outcomes: Executive Summary of a Joint Workshop by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, American College of Obstetricians and Gynecologists, American Academy of Pediatrics, Society for Maternal-Fetal Medicine, Centers for Disease Control and Prevention, and the March of Dimes Foundation. Obstet Gynecol. 2017 Jul;130(1):10-28. doi: 10.1097/AOG.0000000000002054.
Background: PubMed 26066931Jones CM, Campopiano M, Baldwin G, McCance-Katz E. National and State Treatment Need and Capacity for Opioid Agonist Medication-Assisted Treatment. Am J Public Health. 2015 Aug;105(8):e55-63. doi: 10.2105/AJPH.2015.302664. Epub 2015 Jun 11.
Background: PubMed 20809957Milligan K, Niccols A, Sword W, Thabane L, Henderson J, Smith A, Liu J. Maternal substance use and integrated treatment programs for women with substance abuse issues and their children: a meta-analysis. Subst Abuse Treat Prev Policy. 2010 Sep 1;5:21. doi: 10.1186/1747-597X-5-21.
Background: PubMed 25735465Wilder C, Lewis D, Winhusen T. Medication assisted treatment discontinuation in pregnant and postpartum women with opioid use disorder. Drug Alcohol Depend. 2015 Apr 1;149:225-31. doi: 10.1016/j.drugalcdep.2015.02.012. Epub 2015 Feb 19.
BackgroundFlavin J. (2002) A Glass Half Full? Harm reduction amongpregnant women who use cocaine. Journal of Drug Issues, 32(3):973-998. https://journals.sagepub.com/doi/10.1177/002204260203200315
Background: PubMed 20457407Roberts SC, Nuru-Jeter A. Women's perspectives on screening for alcohol and drug use in prenatal care. Womens Health Issues. 2010 May-Jun;20(3):193-200. doi: 10.1016/j.whi.2010.02.003.
Background: PubMed 22260315Wright TE, Schuetter R, Fombonne E, Stephenson J, Haning WF 3rd. Implementation and evaluation of a harm-reduction model for clinical care of substance using pregnant women. Harm Reduct J. 2012 Jan 19;9:5. doi: 10.1186/1477-7517-9-5.
Background: PubMed 23106923Jones HE, Heil SH, Baewert A, Arria AM, Kaltenbach K, Martin PR, Coyle MG, Selby P, Stine SM, Fischer G. Buprenorphine treatment of opioid-dependent pregnant women: a comprehensive review. Addiction. 2012 Nov;107 Suppl 1(0 1):5-27. doi: 10.1111/j.1360-0443.2012.04035.x.
Maine Department of Health and Human Services (DHHS): DHHS to announce the expansion of Medication Assisted Treatment services statewideLink provided by the sponsor.
American College of Obstetricians and Gynecologists. Medical Education: Responding to a national crisis: Opioid Trainings and Clinical GuidanceLink provided by the sponsor.
Norris L. Maine and Affordable Care Act's (ACA) Medicaid Expansion. 2017Link provided by the sponsor.
The Henry J. Kaiser Family Foundation. Delivery System Reform Incentive Payment Program (DSRIP) Waivers in Place. 2017Link provided by the sponsor.
Substance Use and Mental Health Services Administration. Behavioral Health Barometer: United States, 2015. Rockville, Maryland: Substance Abuse and Mental Health Services Administration, 2015Link provided by the sponsor.
Vandonsel A, Livingston, S., Searle, J. Opioids in Vermont: Prevalence, use, and impact. Vermont Department of Health, 2016Link provided by the sponsor.
Individual participant dataSharing planned: No

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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.

Sarah E Lord, PhD principal investigator

Dartmouth College

Daisy Goodman, DNP, MPH principal investigator

Dartmouth-Hitchcock Medical Center

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Opioid-Related Disorders and NAS, run by Trustees of Dartmouth College at 10 sites in United States.

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 5 inclusion and 1 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: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. 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?

Yes. Results are posted in the registry (first posted 23 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Self Report of Medication Treatment for Opioid Use Disorder at 6 Months Postpartum (Yes) (time frame: measured 3rd trimester, 3 months postpartum, 6 months postpartum (reported 6 months postpartum)). The study lists 7 primary outcomes in all. 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 NCT04251208, which also lists 81 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 23 Oct 2026.