Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor

Phase 4TerminatedNCT02438371

The University of Texas Health Science Center, Houston49 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Preterm Labor

Interventions

NifedipineDRUG

IndomethacinDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * We will include pregnant women between 22 0/7 to 31 6/7 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 of at least 1 cm or * cervical dilation of 2 cm at the time of initial exam or * positive fetal fibronectin and 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 the past 48 hours * known adverse effect to indomethacin or nifedipine * already receiving nifedipine for chronic hypertension

Locations (1)

Memorial Hermann Hospital Texas Medical Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Number of Maternal Participants Who Achieve 48 Hours of Pregnancy Prolongation

Time frame: 48 hours after administration of tocolytic agent

Secondary Outcomes

Number of Maternal Participants Who Achieve 7 Days of Pregnancy Prolongation

Time frame: 7 days after administration of tocolytic agent

Number of Days From First Dose of Tocolytic Agent to Delivery

Length of time from tocolytic initiation to the time of delivery

Time frame: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)

Neonatal Birthweight

Time frame: at the time of birth

Neonatal Sex

Time frame: at the time of birth

Number of Neonates Who Were Admitted to the Neonatal Intensive Care Unit (NICU)

Time frame: from birth until hospital discharge or day 120 of life (whichever occurs first)

Neonatal Length of Stay in NICU

Time frame: from birth until hospital discharge or day 120 of life (whichever occurs first)

Neonatal Length of Hospital Stay

Time frame: from birth until hospital discharge or day 120 of life (whichever occurs first)

Number of Neonatal Deaths

Time frame: from birth until hospital discharge or day 120 of life (whichever occurs first)

Number of Neonates With Intraventricular Hemorrhage Diagnosed Using Cranial Ultrasonography

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.