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Preoperative Genotyping for Cesarean Section Complications (PPAP C-Section Trial)

N/A

Recruiting

Led By Senthilkumar Sadhasivam, MD, MPH

Research Sponsored by Senthilkumar Sadhasivam

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adult women (>18 yr) of all races with American Society of Anesthesiologists Classification (ASA) physical status: 1 to 3 undergoing elective Cesarean section who are willing to receive in-patient opioids.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-operative up to 1-year

Awards & highlights

PPAP C-Section Trial Summary

This trial will develop a new platform to improve pain relief and reduce negative outcomes from opioids in breastfeeding mothers and their infants.

Who is the study for?

This trial is for adult women over 18, of any race, with a physical status suitable for elective Cesarean section (ASA 1-3), who plan to use opioids post-surgery and intend to breastfeed. It excludes those with severe preoperative pain or opioid misuse, allergies to oxycodone, liver disease, renal issues, multiple gestations, expected non-viable births or serious neonatal conditions.Check my eligibility

What is being tested?

The study aims to develop a Personalized Perioperative Analgesia Platform (PPAP) that could improve pain management and reduce the adverse effects of opioids in new mothers and their babies after C-sections by using preoperative genotyping.See study design

What are the potential side effects?

While specific side effects are not listed for this genetic approach itself, standard opioid-related risks may include nausea, constipation, drowsiness or respiratory depression. The platform's goal is actually to minimize such side effects.

PPAP C-Section Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult woman planning a C-section and open to using opioids for pain.

PPAP C-Section Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-operative up to 1-year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-operative up to 1-year

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative up to 1-year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Look at genetic factors predisposing patients to immediate postoperative opioid-adverse effects Respiratory Depression (RD) and Postoperative Nausea and Vomiting (PONV)

Look at genetic factors predisposing patients to inadequate surgical pain relief with oxycodone

Secondary outcome measures

Look at the impact of CYP2D6 variants on oxycodone's clinical dosing in patients to see if specific variants correlate with a need for lower or higher doses of analgesic.

Other outcome measures

Look at OPRM1 epigenetics and OPRM1, FAAH, GCH1, DRD2 variants to find correlations with chronic persistent surgical pain (CPSP) up to 1-year post-surgery

Look at OPRM1 epigenetics and OPRM1, FAAH, GCH1, DRD2 variants to find correlations with opioid dependence (OD) up to 1-year post-surgery

PPAP C-Section Trial Design

2Treatment groups

Experimental Treatment

Group I: Mother undergoing planned Cesarean sectionExperimental Treatment1 Intervention

Mother subject will have genotyping blood draw performed at the time of controlled delivery (CD). Blood samples and breast milk samples will also be taken during the oxycodone dosing schedule.

Group II: InfantExperimental Treatment1 Intervention

Infant subject will have genotyping blood draw performed only at the time of controlled delivery (CD)

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Senthilkumar SadhasivamLead Sponsor

4 Previous Clinical Trials

2,300 Total Patients Enrolled

Senthil SadhasivamLead Sponsor

4 Previous Clinical Trials

2,300 Total Patients Enrolled

National Center for Advancing Translational Sciences (NCATS)NIH

320 Previous Clinical Trials

401,130 Total Patients Enrolled

Media Library

Personalized Perioperative Analgesia Platform (PPAP) (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05380531 — N/A

Cesarean Section Complications Research Study Groups: Mother undergoing planned Cesarean section, Infant

Cesarean Section Complications Clinical Trial 2023: Personalized Perioperative Analgesia Platform (PPAP) Highlights & Side Effects. Trial Name: NCT05380531 — N/A

Personalized Perioperative Analgesia Platform (PPAP) (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05380531 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies available for this clinical trial?

"Indeed, the records found on clinicaltrials.gov state that this trial is currently enrolling participants; it was first uploaded to the website on November 16th and last refreshed with new information then as well. In total 600 patients are needed from two different medical facilities."

Answered by AI

Who meets the eligibility requirements to participate in this experiment?

"This investigation is recruiting 600 women between 18-65 years of age who use opioids and are willing to breastfeed for the duration of their study. Moreover, they must meet American Society of Anesthesiologists Classification(ASA) criteria from 1 to 3 in order to qualify."

Answered by AI

Are participants aged 35 or older eligible for this research trial?

"The requirements for this medical trial state that individuals must be aged 18 to 65, with 17 studies available for minors and 129 experiments suitable for the elderly."

Answered by AI

What is the scope of participation for this clinical experiment?

"Indeed, clinicaltrials.gov shows that this research trial is currently recruiting patients; it was initially made public on November 16th 2022 and has been updated since then. 600 people from two sites are needed to participate in the study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section

Senthil Sadhasivam 2022. "Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05380531.