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Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02438371
Recruitment Status : Terminated (Study halted due to slow recruitment)
First Posted : May 8, 2015
Results First Posted : November 24, 2021
Last Update Posted : November 24, 2021
Sponsor:
Information provided by (Responsible Party):
Jerrie Refuerzo, The University of Texas Health Science Center, Houston

Study Description
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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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 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
Actual Study Start Date : May 2015
Actual Primary Completion Date : October 10, 2019
Actual Study Completion Date : October 10, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Nifedipine
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours for a total of 48 hours.
 Drug: Nifedipine
Other Name: Procardia
Active Comparator: Nifedipine plus Indomethacin
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours for a total of 48 hours.
 Drug: Nifedipine
Other Name: Procardia

Drug: Indomethacin


Outcome Measures
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Primary Outcome Measures :
  1. Number of Maternal Participants Who Achieve 48 Hours of Pregnancy Prolongation [ Time Frame: 48 hours after administration of tocolytic agent ]

Secondary Outcome Measures :
  1. Number of Maternal Participants Who Achieve 7 Days of Pregnancy Prolongation [ Time Frame: 7 days after administration of tocolytic agent ]
  2. Number of Days From First Dose of Tocolytic Agent to Delivery [ Time Frame: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months) ]
    Length of time from tocolytic initiation to the time of delivery

  3. Neonatal Birthweight [ Time Frame: at the time of birth ]
  4. Neonatal Sex [ Time Frame: at the time of birth ]
  5. 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) ]
  6. Neonatal Length of Stay in NICU [ Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first) ]
  7. Neonatal Length of Hospital Stay [ Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first) ]
  8. Number of Neonatal Deaths [ Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first) ]
  9. Number of Neonates With Intraventricular Hemorrhage Diagnosed Using Cranial Ultrasonography [ Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first) ]
  10. Number of Neonates With Necrotizing Enterocolitis [ Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first) ]
  11. Number of Neonates With Culture-positive Sepsis [ Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first) ]
  12. Number of Neonates With Seizures [ Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first) ]
  13. Number of Neonates Who Needed Mechanical Ventilation [ Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first) ]
  14. Neonatal Duration of Ventilator Use [ Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first) ]
  15. Number of Neonates Who Received Continuous Positive Airway Pressure (CPAP) [ Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first) ]
  16. Number of Maternal Participants Who Delivered by Cesarean Delivery [ Time Frame: at the the time of birth ]
  17. Number of Maternal Participants Who Had Clinical Chorioamnionitis [ Time Frame: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months) ]
  18. Number of Maternal Participants Who Had Preterm Premature Rupture of Membranes (PPROM) [ Time Frame: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months) ]
  19. Number of Maternal Participants Who Had Preeclampsia [ Time Frame: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months) ]
  20. Number of Maternal Participants Who Needed Blood Transfusion [ Time Frame: from time of birth to time of discharge from hospital (about 2-3 days) ]
  21. Number of Maternal Participants With Headache [ Time Frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months) ]
  22. Number of Maternal Participants With Nausea [ Time Frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months) ]
  23. Number of Maternal Participants With Vomiting [ Time Frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months) ]
  24. Number of Maternal Participants With Acid Reflux [ Time Frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months) ]
  25. Number of Maternal Participants With Hypotension [ Time Frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months) ]
  26. Number of Maternal Participants With Tachycardia [ Time Frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months) ]
  27. Number of Maternal Participants With Syncope [ Time Frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months) ]

Eligibility Criteria
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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 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
Contacts and Locations
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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


Locations
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United States, Texas
Memorial Hermann Hospital Texas Medical Center
Houston, Texas, United States, 77030
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
  Study Documents (Full-Text)

Documents provided by Jerrie Refuerzo, The University of Texas Health Science Center, Houston:
Study Protocol and Statistical Analysis Plan  [PDF] May 2, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jerrie Refuerzo, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02438371    
Other Study ID Numbers: HSC-MS-15-0134
First Posted: May 8, 2015    Key Record Dates
Results First Posted: November 24, 2021
Last Update Posted: November 24, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
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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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Indomethacin
Nifedipine
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