Pregnancy Clinical Trial
Official title:
Pharmacokinetic and Pharmacogenomic Approach to Indomethacin Therapy in Pregnancy
Verified date | February 2018 |
Source | The University of Texas Medical Branch, Galveston |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 62 |
Est. completion date | December 31, 2018 |
Est. primary completion date | December 31, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: To be enrolled in the study, patients must meet all of the following criteria: 1. Age at least 18 years 2. Singleton gestation 3. 12 0/7 to 32 0/7 weeks gestation (see Gestational Age Determination section 3.2.1.1) 4. Patient receiving indomethacin for any of the following diagnoses: 1. Preterm labor: regular uterine contractions with documented cervical change or dilatation = 2 cm and 80% effacement 2. Cervical shortening (< 2.5 cm documented on transvaginal ultrasound) with or without funneling membranes 3. Planned cervical cerclage or emergent cerclage 4. Other condition whereby Indomethacin is indicated 5. Maternal and fetal condition allows anticipated delay of delivery for more than 24 hours - Exclusion Criteria: - Exclusion criteria include: 1. Contraindications to indomethacin use (history of maternal bleeding disorder, thrombocytopenia, maternal hepatic, gastrointestinal ulcerative, or renal dysfunction, asthma) 2. Known fetal abnormality, genetic syndrome, or intrauterine fetal demise 3. Anticipated delivery in less than 24 hours, cervical dilatation > 6 cm 4. Preterm premature rupture of membranes 5. Suspected chorioamnionitis 6. Oligohydramnios (DVP < 2 cm) 7. Congenital Uterine anomaly 8. Vaginal bleeding due to suspected placental abruption or placenta previa 9. Planned preterm delivery for maternal/fetal indications 10. Non-reassuring fetal status 11. Planned delivery outside UTMB or participation in another intervention trial which may affect maternal or neonatal outcomes 12. Unsure gestational age due to possibility of intrauterine growth restriction 13. Hematocrit <28% (as determined by most recent result within 1 month of enrollment) 14. Prisoners |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama | Birmingham | Alabama |
United States | Duke University | Durham | North Carolina |
United States | University of Texas Medical Branch, Dept of OB/GYN | Galveston | Texas |
United States | University of Mississippi Medical Center | Jackson | Mississippi |
United States | Columbia University | New York | New York |
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Medical Branch, Galveston | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gestational age at delivery | Gestational age at delivery calculated from the first day of last menstrual period unless "unsure" and then it will be calculated from ultrasound measurements | Enrollment until delivery of the participant | |
Secondary | Maternal outcomes | Diagnosed maternal outcomes including oligohydramnios, chorioamnionitis, preterm premature rupture of membranes, venous thromboembolism, pulmonary edema, postpartum hemorrhage, and maternal death | Enrollment until delivery and maternal discharge | |
Secondary | Neonatal outcomes | Diagnosed neonatal outcomes including birth weight, APGAR scores, neonatal sepsis, respiratory distress syndrome, patent ductus arteriosis, necrotizing enterocolitis, broncopulmonary dysplasia, paraventricular leukomalacia, intraventricular hemorrhage, fetal, or neonatal death | The earlier of neonatal discharge or up to 120 days postnatal | |
Secondary | Neonatal admission to Neonatal intensive care unit (NICU) | Documentation of NICU admission [yes/no] | The earlier of neonatal discharge or up to 120 days postnatal | |
Secondary | Length of stay in the Neonatal intensive care unit (NICU) | If admitted to the NICU, number of days in the NICU | The earlier of neonatal discharge or up to 120 days postnatal |
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