Indomethacin PK and PD Therapy in Pregnancy
Completed
Conditions studied: Premature Labor, Pregnancy, Premature Birth
In brief
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.
Key facts
- Study ID
- NCT02451228
- Run by
- The University of Texas Medical Branch, Galveston
- People needed
- 62
- Starts
- 2015-05-01
- Expected to finish
- 2018-12-31
- Last updated by the study team
- 2019-06-11
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- To be enrolled in the study, patients must meet all of the following criteria:
- Age at least 18 years
- Singleton gestation
- 12 0/7 to 32 0/7 weeks gestation (see Gestational Age Determination section 3.2.1.1)
- Patient receiving indomethacin for any of the following diagnoses:
- Preterm labor: regular uterine contractions with documented cervical change or dilatation ≥ 2 cm and 80% effacement
- Cervical shortening (< 2.5 cm documented on transvaginal ultrasound) with or without funneling membranes
- Planned cervical cerclage or emergent cerclage
- Other condition whereby Indomethacin is indicated
- Maternal and fetal condition allows anticipated delay of delivery for more than 24 hours -
You may not qualify if…
- Exclusion criteria include:
- Contraindications to indomethacin use (history of maternal bleeding disorder, thrombocytopenia, maternal hepatic, gastrointestinal ulcerative, or renal dysfunction, asthma)
- Known fetal abnormality, genetic syndrome, or intrauterine fetal demise
- Anticipated delivery in less than 24 hours, cervical dilatation > 6 cm
- Preterm premature rupture of membranes
- Suspected chorioamnionitis
- Oligohydramnios (DVP < 2 cm)
- Congenital Uterine anomaly
- Vaginal bleeding due to suspected placental abruption or placenta previa
- Planned preterm delivery for maternal/fetal indications
- Non-reassuring fetal status
- Planned delivery outside UTMB or participation in another intervention trial which may affect maternal or neonatal outcomes
- Unsure gestational age due to possibility of intrauterine growth restriction
- Hematocrit <28% (as determined by most recent result within 1 month of enrollment)
- Prisoners
Where it is running
- University of Alabama — Birmingham, Alabama, United States
- University of Mississippi Medical Center — Jackson, Mississippi, United States
- Columbia University — New York, New York, United States
- Duke University — Durham, North Carolina, United States
- University of Texas Medical Branch, Dept of OB/GYN — Galveston, Texas, United States
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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