Clinical Trials Logo
  1. Home
  2. Pregnancy
  3. NCT02451228

Indomethacin PK and PD Therapy in Pregnancy

Pregnancy Clinical Trial

Official title:
Pharmacokinetic and Pharmacogenomic Approach to Indomethacin Therapy in Pregnancy

Clinical Trial Summary

This study will follow pregnant women who are taking indomethacin as Standard of Care (SOC) for the indications of preterm labor (PTL), short cervix, or other indications, to evaluate the pharmacokinetics (PK), what the body does to the drug, and pharmacodynamics (PD), effectiveness of the drug in treating the specific intended disease process of this medication. This will help us develop more information for medication dosing specific to pregnant women experiencing preterm labor.

Indomethacin is often prescribed to pregnant women presenting with preterm labor or shortened cervix, which places them at risk for preterm labor and delivery. Indomethacin has been used since the 1970s to prolong pregnancy by decreasing uterine contractions. However, despite the widespread use of indomethacin in pregnancy, there is limited information available to help physicians determine how much indomethacin to prescribe and how often to prescribe it.

Clinical Trial Description

Opportunistic study of indomethacin prescribed to patients per standard of care. Determine the pharmacokinetics, pharmacodynamics and pharmacogenomics of Indomethacin in pregnant patients with the hypothesis that that estradiol levels during pregnancy (12-32 weeks of gestation) and CYP2C9 polymorphisms affect the PK of indomethacin, and subsequently, the response to indomethacin therapy in patients at risk of Preterm birth (PTB). This hypothesis will be tested with the following specific aims: (1) Determine the PK of indomethacin in pregnant women at risk of PTB and its PD effects on reducing the rate of PTB before 34 weeks of gestation, as well as any associations between the PK and secondary maternal/neonatal clinical outcomes; (2) Determine the effects of maternal levels of estradiol in mid-pregnancy and CYP2C9 polymorphisms on indomethacin biotransformation to O-desmethylindomethacin in pregnant patients; (3) Construct a population PK/PD model of indomethacin in patients at risk of PTB (12-32 weeks of gestation) in order to optimize the dose and the dosing frequency for indomethacin prescribed to each individual based on covariates such as race/ethnicity, CYP2C9 genotype, gestational age, estradiol levels, smoking status, and body mass index (BMI). The investigators will enroll 300 subjects with spontaneous preterm labor (sPTL) or shortened cervix in a prospective opportunistic PK study designed to correlate the PK of indomethacin, patient genotype, and clinical outcomes. The investigators will merge dosing, sampling, demographic, and clinical information with the drug concentration data and use population PK methodologies to analyze the data using nonlinear mixed effect modeling. Quantification of the differences within and between individuals allows for identification of covariates (e.g., CYP2C9 genotype, estradiol levels, BMI, etc.) that can explain variability and affect drug exposure. These covariates, if significant, can then be used in the future to optimize dosing in individual patients at risk for PTB. Achieving this goal of individualized indomethacin therapy could have a significant impact on clinical practice and improve maternal and neonatal outcomes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02451228
Study type Observational
Source The University of Texas Medical Branch, Galveston
Contact
Status Completed
Phase
Start date May 2015
Completion date December 31, 2018
View Details
See also
  Status Clinical Trial Phase
Completed NCT03442582 - Afluria Pregnancy Registry
Terminated NCT02161861 - Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study N/A
Not yet recruiting NCT05934318 - L-ArGinine to pRevent advErse prEgnancy Outcomes (AGREE) N/A
Enrolling by invitation NCT05415371 - Persistent Poverty Counties Pregnant Women With Medicaid N/A
Completed NCT04548102 - Effects of Fetal Movement Counting on Maternal and Fetal Outcome Among High Risk Pregnant Woman N/A
Completed NCT03218956 - Protein Requirement During Lactation N/A
Completed NCT02191605 - Computer-delivered Screening & Brief Intervention for Marijuana Use in Pregnancy N/A
Completed NCT02223637 - Meningococcal Quadrivalent CRM-197 Conjugate Vaccine Pregnancy Registry
Recruiting NCT06049953 - Maternal And Infant Antipsychotic Study
Completed NCT02577536 - PregSource: Crowdsourcing to Understand Pregnancy
Not yet recruiting NCT06336434 - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy Phase 1/Phase 2
Not yet recruiting NCT04786587 - Alcohol Self-reporting During Pregnancy. AUTOQUEST Study.
Not yet recruiting NCT05412238 - Formulation and Evaluation of the Efficacy of Macro- and Micronutrient Sachets on Pregnant Mothers and Children Aged 6-60 Months N/A
Not yet recruiting NCT05028387 - Telemedicine Medical Abortion Service Using the "No-test" Protocol in Ukraine and Uzbekistan.
Completed NCT02783170 - Safety and Immunogenicity of Simultaneous Tdap and IIV in Pregnant Women Phase 4
Completed NCT02683005 - Study of Hepatitis C Treatment During Pregnancy Phase 1
Recruiting NCT02507180 - Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
Recruiting NCT02564250 - Maternal Metabolism and Pregnancy Outcomes in Obese Pregnant Women N/A
Recruiting NCT02619188 - Nutritional Markers in Normal and Hyperemesis Pregnancies N/A
Completed NCT02379728 - Ghana PrenaBelt Trial: A Positional Therapy Device to Reduce Still-Birth N/A