Pregnancy Related Clinical Trial
Official title:
NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs): a Pragmatic Randomized Trial Comparing Extended-release and Daily Buprenorphine Formulations: Conceptual Model Assessments (CMA) Sub-study
This is a sub-study of NIDA CTN Protocol 0080: Medication Treatment for Opioid Use Disorder in Expectant Mothers (MOMs; Unique protocol ID: 2019-0429-1). Participants in MOMs will be offered the opportunity to enroll in this sub-study, which is designed to evaluate conceptual models of the mechanisms by which extended-release buprenorphine (BUP-XR), may improve mother-infant outcomes, compared to sublingual buprenorphine (BUP-SL). The additional data collected in this sub-study will be combined with data from the main MOMs trial. It is hypothesized that: (1) the buprenorphine blood levels will vary, depending on which formulation of buprenorphine was received, (2) the variation in buprenorphine blood levels will be associated with fetal behavior (including fetal heart rate variability) (3) the variation in buprenorphine blood levels will be associated with differences in mother outcomes (including medication adherence and illicit opioid use) (4) the variation in buprenorphine blood levels and in fetal behavior will be associated with infant outcomes (including neonatal opioid withdrawal syndrome and infant development).
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05017974 -
Research on Improving Sleep During Pregnancy
|
N/A | |
| Completed |
NCT03284515 -
Vaccination In Pregnancy Gene Signature: VIP Signature Study
|
||
| Recruiting |
NCT05969795 -
Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
|
Phase 1 | |
| Recruiting |
NCT06051201 -
Innovation for Small-scale Experiments: ReceptIVFity Test
|
N/A | |
| Recruiting |
NCT04828382 -
Prospective Study of Pregnancy in Women With Cystic Fibrosis
|
||
| Enrolling by invitation |
NCT04527926 -
STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy
|
N/A | |
| Recruiting |
NCT04278651 -
Early Antenatal Support for Iron Deficiency Anemia
|
Phase 4 | |
| Recruiting |
NCT04405700 -
Measuring Adverse Pregnancy and Newborn Congenital Outcomes
|
||
| Recruiting |
NCT06258902 -
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
|
||
| Completed |
NCT05487196 -
Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
|
Phase 2 | |
| Completed |
NCT03750968 -
Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
|
Phase 2 | |
| Enrolling by invitation |
NCT06127277 -
Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care
|
N/A | |
| Completed |
NCT05897697 -
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
|
||
| Recruiting |
NCT05899101 -
The Impact of Opioid and Cannabis Exposure on Fetal Growth
|
||
| Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
| Completed |
NCT04296396 -
Opioid Prescription After Cesarean Trial
|
Phase 3 | |
| Not yet recruiting |
NCT06069869 -
Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial
|
Phase 3 | |
| Not yet recruiting |
NCT06069856 -
Multiple Micronutrient Supplementation (MMS) IFA- Iron Dose Acceptability Crossover Trial
|
Phase 3 | |
| Not yet recruiting |
NCT06163651 -
Evaluating a One-Year Version of the Parent-Child Assistance Program
|
N/A | |
| Not yet recruiting |
NCT06079918 -
Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania
|
Phase 3 |