Cesarean Section ComplicationsPRECISE-CDNCT05280743
Precision Opioid Care After Cesarean Delivery (PRECISE-CD)
An observational study of Cesarean Section Complications and Opioid Use, run by Grace Lim, MD, MS at 1 site in United States.
Trial summary
The purpose of this research is to study serious clinical problems from surgical pain and the use of oxycodone or other opioids in women having a Cesarean Delivery to improve the safety and efficacy of surgical pain relief. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Section Complications, Opioid Use
- What is being tested?
- Oxycodone
- How many people
- 341 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- Adult, Older adult
Study population: Participants who have Cesarean Delivery and who plan to breast feed their infants
Who may be able to join
- Pregnant Adult women (>18 y) and their infants
- All races
- ASA physical status 2 to 3
- Cesarean delivery at UPMC Magee
- Planned breast feeding mothers and their infants
Who cannot join
- Serious illnesses or condition of either mother or infant precluding ability to participate in study procedures
- Multiple gestation pregnancies
- Preoperative severe pain and opioid use/misuse
- Allergy to oxycodone
- Women with opioid use disorder
- Any known condition that anticipates neonatal observation in NICU immediately after birth
Show all 12Show fewer
- General anesthesia anticipated or converted intraoperatively
- Expected non-viable current gestation or serious neonatal health comorbidities anticipated prior to delivery
- Severe neurological disorder: any known untreated or uncontrolled seizure disorder, pre-eclampsia with severe features, pre-eclampsia requiring magnesium, elevated ICP other than benign intracranial hypertension condition, or conditions at the discretion of PI
- Liver disease: any known abnormal live function tests, or conditions at the discretion of PI
- Renal diseases: any chronic or acute renal insufficiency, or pre-eclampsia diagnosis with abnormal renal function i.e.: severe features, or conditions at the discretion of PI.
- Contraindications to neuraxial anesthesia, neuraxial morphine, acetaminophen, or NSAIDs which are standard parts of post-cesarean multimodal analgesia
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Avoiding Adverse Opioid Outcomes With Proactive Precision Care Following Cesarean Delivery
The purpose of this research is to study serious clinical problems from surgical pain and the use of oxycodone or other opioids in women having a Cesarean Delivery to improve the safety and efficacy of surgical pain relief. This research will ultimately improve the safety and efficacy of surgical pain relief with opioids by preoperative risk predictions and personalized care with the right dose of the right analgesic for each patient.
Read the detailed description
The overall objective is to determine the impact of risk factors on oxycodone and other opioid's adverse postoperative outcomes and to personalize dosing in women having a Cesarean Delivery. For the purpose of this study, immediate adverse postoperative outcomes are characterized as Respiratory Depression (RD), Postoperative Nausea and Vomiting (PONV), and inadequate surgical pain relief. Long-term adverse postoperative outcomes are characterized as Chronic Persistent Surgical Pain (CPSP) and Opioid Dependence (OD).
The central hypothesis is that specific genetic factors in pain-opioid pathways significantly impact oxycodone and opioid dosing, analgesia, immediate adverse effects (RD and PONV), and long-term adverse outcomes (CPSP and OD).
The aims of this project are to validate genetic variants and to develop a test for preoperative risk prediction in lactating mothers and breastfed babies following cesarean delivery (CD). There is an urgent and unmet critical need for reliable technology to improve safety and effectiveness of opioid use in special populations.
Aim 1. Validate and identify genetic risk factors associated with postoperative opioid adverse effects, PONV and RD in adult nursing mothers following CD.
Investigators hypothesize that with standardized and genotype-blinded perioperative care, specific variants will identify nursing mothers at risk for opioid-induced RD and PONV (primary outcome), OD and severe pain following CD. In addition, genetic variants will identify risk for opioid-induced sedation and adverse effects in breastfed infants. In addition to clinical outcomes, the investigators will collect post-CD cost of care including length of stay.
Aim 2. Develop a laboratory-developed test (LDT) at University of Pittsburgh Genome Center (UGC) for preoperative genetic risk prediction and decision support for surgical patients to prevent adverse opioid outcomes. Investigators will develop a minimum viable product (MVP) (CPT code: 81227), a refined multi-gene panel in UGC's CLIA certified laboratory with a robust combinatorial pharmacogenetic decision support to personalize surgical analgesia with precise opioid use in children and adults, and to prevent RD, PONV, CPSP and OD.
- Conditions
- Cesarean Section Complications, Opioid Use
- Being tested
- Oxycodone
- Keywords
- Personalized Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxycodoneDrug
Also called Opioid Exposure
exposure to opioids after Cesarean Section
| Study group | Role | What they receive |
|---|---|---|
| MATERNAL cohort | Nursing mothers who underwent Cesarean Delivery and who are receiving oxycodone to treat post-operative pain Receives: Drug: Oxycodone | |
| NEONATE-INFANT cohort | Neonate" encompasses a newborn from the age of birth until <28 days of life. "Infant" refers to the period of 28 days of life until 1 year of life. Receives: Drug: Oxycodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid-Induced Adverse Effects-PROPORTION of maternal participants with RD
Respiratory depression (RD) measured as Yes or No in occurrence.
Measured: From time of surgery to time of discharge up to 3 days post-surgery
Opioid-Induced Adverse Effects-PROPORTION of maternal participants with PONV
Postoperative Nausea and Vomiting (PONV) Intensity Scale. Participants will be categorized as Clinically relevant (Yes) or Not clinically relevant (No) Nausea and Vomiting from the PONV scale. Clinically important PONV is defined as a total score >50 at any time throughout the study period.
Measured: From time of surgery to time of discharge up to 3 days post-surgery
Secondary outcomes (9)
Maternal Post-operative Pain Scores
Numerical Rating Scale (NRS). The pain scale is from 0 to 10, 0 being "no pain" and 10 being "the worst pain imaginable"
Measured: From time of delivery to 12-month post-surgery
Total Maternal Inpatient Opioid Use
measured in milligrams of Morphine Equivalents
Measured: From time of surgery to discharge-- up to 3 days post-surgery
Extended Hospital Length of Stay-Maternal
Yes/No Proportion of Women discharged beyond 72-hours post-surgery
Measured: From surgery to 72 hours postoperation
Length of prescribed opioid use (For Mothers; in days)
Number of days patients take opioids post-surgery.
Measured: From day of surgery to 12-month post-surgery
Neonatal Sedation-- PROPORTION of infants with Sedation
Defined as YES (any sleeping > 4 hours in hospital or first week of life) or NO (sleeping) less than 4 hours at a time.
Measured: From birth to 7-days post-birth
Neonatal Respiratory Depression--PROPORTION of neonates diagnosed with RD
Yes/No Yes: Defined as respiratory rate 8 or fewer breaths per minute
Measured: From birth to time of discharge (up to 3 days post-birth)
Extended Hospital Length of Stay-Neonate
Yes/No Proportion of neonates staying in hospital longer than 72-hours (Yes)
Measured: From time of delivery to 72-hours post-delivery
Neonatal Limpness (reporting limpness > 0, or not limp =0)
Proportion of Infants with Limpness reported
Measured: From birth to 72-hours post-delivery
Proportion of Neonates Exhibiting opioid withdrawal
SOWSS Sophia Observation Withdrawal Symptoms-Scale; Yes (withdrawal symptoms (scores >4)/No (withdrawal symptoms < 4)
Measured: Birth to 3-days postpartum (or discharge from hospital)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start28 Mar 2022
- Primary completion24 Sep 2023
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies 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
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grace Lim, MD, MS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Grace Lim, MD, MS, University of Pittsburgh
- Investigators
- Grace Lim, MD MSc, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05280743
- Sponsor's protocol ID
- STUDY21070164
- Acronym
- PRECISE-CD
- Status last verified
- Jul 2024
- First submitted
- 6 Mar 2022
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avoiding Adverse Opioid Outcomes With Proactive Precision Care Following Cesarean Delivery
- ClinicalTrials.gov ID
- NCT05280743
- Acronym / sponsor ID
- PRECISE-CD / STUDY21070164
- Conditions
- Cesarean Section Complications, Opioid Use
- Keywords
- Personalized Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Grace Lim, MD, MSUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 24 Sep 2023 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to study serious clinical problems from surgical pain and the use of oxycodone or other opioids in women having a Cesarean Delivery to improve the safety and efficacy of surgical pain relief. This research will ultimately improve the safety and efficacy of surgical pain relief with opioids by preoperative risk predictions and personalized care with the right dose of the right analgesic for each patient.
Detailed description
The overall objective is to determine the impact of risk factors on oxycodone and other opioid's adverse postoperative outcomes and to personalize dosing in women having a Cesarean Delivery. For the purpose of this study, immediate adverse postoperative outcomes are characterized as Respiratory Depression (RD), Postoperative Nausea and Vomiting (PONV), and inadequate surgical pain relief. Long-term adverse postoperative outcomes are characterized as Chronic Persistent Surgical Pain (CPSP) and Opioid Dependence (OD).
The central hypothesis is that specific genetic factors in pain-opioid pathways significantly impact oxycodone and opioid dosing, analgesia, immediate adverse effects (RD and PONV), and long-term adverse outcomes (CPSP and OD).
The aims of this project are to validate genetic variants and to develop a test for preoperative risk prediction in lactating mothers and breastfed babies following cesarean delivery (CD). There is an urgent and unmet critical need for reliable technology to improve safety and effectiveness of opioid use in special populations.
Aim 1. Validate and identify genetic risk factors associated with postoperative opioid adverse effects, PONV and RD in adult nursing mothers following CD.
Investigators hypothesize that with standardized and genotype-blinded perioperative care, specific variants will identify nursing mothers at risk for opioid-induced RD and PONV (primary outcome), OD and severe pain following CD. In addition, genetic variants will identify risk for opioid-induced sedation and adverse effects in breastfed infants. In addition to clinical outcomes, the investigators will collect post-CD cost of care including length of stay.
Aim 2. Develop a laboratory-developed test (LDT) at University of Pittsburgh Genome Center (UGC) for preoperative genetic risk prediction and decision support for surgical patients to prevent adverse opioid outcomes. Investigators will develop a minimum viable product (MVP) (CPT code: 81227), a refined multi-gene panel in UGC's CLIA certified laboratory with a robust combinatorial pharmacogenetic decision support to personalize surgical analgesia with precise opioid use in children and adults, and to prevent RD, PONV, CPSP and OD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MATERNAL cohort | – | Drug: OxycodoneNursing mothers who underwent Cesarean Delivery and who are receiving oxycodone to treat post-operative pain |
| NEONATE-INFANT cohort | – | Drug: OxycodoneNeonate" encompasses a newborn from the age of birth until <28 days of life. "Infant" refers to the period of 28 days of life until 1 year of life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Participants who have Cesarean Delivery and who plan to breast feed their infants
Key inclusion criteria (5 listed)
- Pregnant Adult women (>18 y) and their infants
- All races
- ASA physical status 2 to 3
- Cesarean delivery at UPMC Magee
- Planned breast feeding mothers and their infants
Key exclusion criteria (12 listed)
- Serious illnesses or condition of either mother or infant precluding ability to participate in study procedures
- Multiple gestation pregnancies
- Preoperative severe pain and opioid use/misuse
- Allergy to oxycodone
- Women with opioid use disorder
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 |
|---|---|---|
| OxycodoneAlso: Opioid Exposureexposure to opioids after Cesarean Section | Drug | MATERNAL cohort, NEONATE-INFANT cohort |
Primary outcome
Opioid-Induced Adverse Effects-PROPORTION of maternal participants with RD
Time frame: From time of surgery to time of discharge up to 3 days post-surgery
Respiratory depression (RD) measured as Yes or No in occurrence.
Opioid-Induced Adverse Effects-PROPORTION of maternal participants with PONV
Time frame: From time of surgery to time of discharge up to 3 days post-surgery
Postoperative Nausea and Vomiting (PONV) Intensity Scale. Participants will be categorized as Clinically relevant (Yes) or Not clinically relevant (No) Nausea and Vomiting from the PONV scale. Clinically important PONV is defined as a total score >50 at any time throughout the study period.
9 secondary outcomes
Maternal Post-operative Pain Scores
Time frame: From time of delivery to 12-month post-surgery
Total Maternal Inpatient Opioid Use
Time frame: From time of surgery to discharge-- up to 3 days post-surgery
Extended Hospital Length of Stay-Maternal
Time frame: From surgery to 72 hours postoperation
Length of prescribed opioid use (For Mothers; in days)
Time frame: From day of surgery to 12-month post-surgery
Neonatal Sedation-- PROPORTION of infants with Sedation
Time frame: From birth to 7-days post-birth
Neonatal Respiratory Depression--PROPORTION of neonates diagnosed with RD
Time frame: From birth to time of discharge (up to 3 days post-birth)
Extended Hospital Length of Stay-Neonate
Time frame: From time of delivery to 72-hours post-delivery
Neonatal Limpness (reporting limpness > 0, or not limp =0)
Time frame: From birth to 72-hours post-delivery
Proportion of Neonates Exhibiting opioid withdrawal
Time frame: Birth to 3-days postpartum (or discharge from hospital)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
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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.
Grace Lim, MD MSc principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section Complications and Opioid Use, run by Grace Lim, MD, MS at 1 site 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 12 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 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Opioid-Induced Adverse Effects-PROPORTION of maternal participants with RD (time frame: From time of surgery to time of discharge up to 3 days post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2024; AzTrials last refreshed its copy on 30 Oct 2026.