Houston, Texas 77030


Purpose:

Tocolytic agents are used for the treatment of preterm labor. It is unclear whether combination treatments of two tocolytic agents are more effective in stopping preterm labor compared to one. Therefore, the investigators propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor


Study summary:

The investigators current treatment for preterm labor has not been shown to be effective in prolonging pregnancy sufficiently to improve neonatal outcomes and other treatment strategies are needed. Multiple examples demonstrate that multi-agent treatments are routine clinical practice in other fields of medicine including chemotherapeutics for cancer, multi-therapeutics for myocardial infarction and broad spectrum antibiotics for pneumonia. At this time, it is unclear if a combination of tocolytic medications for preterm labor is more advantageous for women. If pregnancy is prolonged with combined tocolytic therapy, this could directly influence the treatment of preterm labor and potentially improve neonatal outcomes. There currently are no trials of combination regimens using widely used tocolytic agents, such as nifedipine and indomethacin. Thus, we propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor


Criteria:

Inclusion Criteria: - We will include pregnant women between 220/7 to 316/7 weeks gestation who present with regular uterine contractions defined as at least one contraction every 10 minutes for 30 minutes with at least one of the following: - cervical change or - 2 cm dilated or - positive fetal fibronectin or - transvaginal cervical length <2.5 cm Exclusion Criteria: - We will exclude pregnant women with any contraindication to tocolysis: - clinical chorioamnionitis (defined as a temperature of >100.4 F and any of the following: fundal tenderness, maternal tachycardia, fetal tachycardia or purulent vaginal discharge) - non reassuring fetal heart tones - suspected placental abruption - preterm premature rupture of membranes - prior tocolytic treatment during their pregnancy - known adverse effect to indomethacin or nifedipine


NCT ID:

NCT02438371


Primary Contact:

Study Director
Maria Hutchinson, M.S.
The University of Texas Health Science Center, Houston

Jerrie Refuerzo, M.D.
Phone: 713-500-6416
Email: jerrie.s.refuerzo@uth.tmc.edu


Backup Contact:

Email: nana.ama.e.ankumah@uth.tmc.edu
Nana Ankumah, M.D.
Phone: 713-500-6421


Location Contact:

Houston, Texas 77030
United States

Jerrie S Refuerzo, M.D.
Phone: 713-500-6416
Email: Jerrie.S.Refuerzo@uth.tmc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 22, 2017

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