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Decreasing Opioid Misuse and Habit-forming Behaviors Following Prescription in Patients Undergoing Cesarean Section
NCT05461196 · View on ClinicalTrials.gov ↗
Study Summary
Background: Cesarean delivery is one of the most common obstetric procedures experienced among women who are pregnant.1 Women with Cesarean deliveries have a higher rate of peripartum opioid prescriptions and persistent opioid use compared to those with vaginal deliveries.2 Since 2002, prescription opioid use and misuse has significantly increased among women, including those who are pregnant, showing over 31% increase in past-month heroin use among women of childbearing age.3 This indicates the importance of focusing on maternal population for prescribed opioid medication management during the immediate postpartum period to prevent long-term persistent opioid misuse. Few evidence-based approaches are available to remotely manage prescription opioid use post-discharge.4 Recent advances in mobile technology have made it possible to monitor behavior and maintain communication in near real-time, long after patients are discharged from their surgical procedures.5-7 Using a virtual platform via use of mobile technology offers potential for sustainable implementation of a behavioral intervention and patient-provider communication even during the COVID-19 pandemic.8 Continuous Precision Medicine (CPM™; Research Triangle Park, NC) has developed a mobile app to overcome these barriers for tracking pain and pain medication use among post-surgery patients and tested the logistical and technological feasibility in postpartum patients at Temple OB/GYN. Collectively, our team brings expertise and collaborations between Temple University Hospital, RTI International, and CPM for the following Specific Aims: Aim 1: To examine the preliminary impact of the CPM mobile app to reduce the use of opioids among women post-Cesarean surgery Hypothesis 1: Patients using the CPM application will use fewer Morphine Milligram Equivalents (MME) compared to the blister package group. Aim 2: To establish correlates of pain medication use among women post-Cesarean surgery to estimate the appropria
Conditions Studied
Interventions
- BEHAVIORAL CPMRx
Study Locations (1)
Pennsylvania
- Temple University — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-05-12 |
| Est. Completion | 2022-08-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05461196
The ClinicalTrials.gov registry entry for NCT05461196 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jessica Morgan, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Opioid Misuse appearing as the primary indexed condition, and to 1 intervention — of which CPMRx is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05461196 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05461196 about?
NCT05461196 is a clinical study titled "Decreasing Opioid Misuse and Habit-forming Behaviors Following Prescription in Patients Undergoing Cesarean Section". Background: Cesarean delivery is one of the most common obstetric procedures experienced among women who are pregnant.1 Women with Cesarean deliveries have a higher rate of peripartum opioid prescriptions and persistent opioid use compared to those with vaginal deliveries.2 Since 2002, prescription ...
What is the current status of trial NCT05461196?
This trial is currently completed. It is a NA study. The enrollment target is 100 participants. The study started on 2021-05-12. Estimated completion is 2022-08-01.
What conditions does trial NCT05461196 study?
This clinical trial studies the following conditions: Opioid Misuse. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05461196?
The interventions under investigation include: CPMRx (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05461196?
This trial is sponsored by Jessica Morgan, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05461196 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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