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Indomethacin PK and PD Therapy in Pregnancy

NCT02451228 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2019-06-11

No results posted yet for this study

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.

Conditions

  • Premature Labor
  • Pregnancy
  • Premature Birth

Interventions

OTHER

Serial blood collection

Serial blood collection from IV for pharmacokinetic and pharmacodynamic analysis. No drug, device, or biologic intervention. Opportunistic.

Sponsors & Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Principal Investigators

  • Gary Hankins, MD · University of Texas

  • Erik Rytting, PhD · University of Texas

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2018-12-31
Completion
2018-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02451228 on ClinicalTrials.gov