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Trial record 12 of 143 for:    NIFEDIPINE

Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor

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ClinicalTrials.gov Identifier: NCT02438371
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Jerrie Refuerzo, The University of Texas Health Science Center, Houston

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Preterm Labor Drug: Nifedipine Drug: Indomethacin Phase 4

Detailed Description:
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nifedipine Alone or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor: An Open Label, Randomized Comparative Effectiveness Controlled Trial
Study Start Date : May 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Single
They will receive nifedipine for the treatment of preterm labor
Drug: Nifedipine
Nifedipine will be given for the treatment of preterm labor
Other Name: Procardia

Active Comparator: Combination
They will receive nifedipine plus indomethacin
Drug: Nifedipine
Nifedipine will be given for the treatment of preterm labor
Other Name: Procardia

Drug: Indomethacin
Nifedipine and indomethacin will be give for the treatment of pretermlabor
Other Name: Indomethacin and Nifedipine




Primary Outcome Measures :
  1. The percentage of women who remain pregnant [ Time Frame: 48 hours ]

Secondary Outcome Measures :
  1. Length of pregnancy [ Time Frame: up to 9 months ]
    Length of time from tocolytic initiation to the time of delivery



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438371


Contacts
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Contact: Jerrie Refuerzo, M.D. 713-500-6416 jerrie.s.refuerzo@uth.tmc.edu
Contact: Nana Ankumah, M.D. 713-500-6421 nana.ama.e.ankumah@uth.tmc.edu

Locations
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United States, Texas
Memorial Hermann Hospital Texas Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Jerrie S Refuerzo, M.D.    713-500-6416    Jerrie.S.Refuerzo@uth.tmc.edu   
Contact: Maria Hutchinson, M.S    713-500-5850    Maria.S.Keefer@uth.tmc.edu   
Principal Investigator: Jerrie S Refuerzo, M.D.         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Study Director: Maria Hutchinson, M.S. The University of Texas Health Science Center, Houston

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Responsible Party: Jerrie Refuerzo, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02438371     History of Changes
Other Study ID Numbers: HSC-MS-15-0134
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018
Keywords provided by Jerrie Refuerzo, The University of Texas Health Science Center, Houston:
pregnancy
preterm labor
tocolysis
Additional relevant MeSH terms:
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Nifedipine
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Indomethacin
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors