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Nifedipine for Acute Tocolysis of Preterm Labor (Nifedipine)

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ClinicalTrials.gov Identifier: NCT02132533
Recruitment Status : Completed
First Posted : May 7, 2014
Results First Posted : February 21, 2020
Last Update Posted : December 21, 2020
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Study Description
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Brief Summary:
The purpose of this study is to determine if nifedipine treatment of women in preterm labor receiving corticosteroids results in postponement of delivery when compared to placebo.

Condition or disease Intervention/treatment Phase
Preterm Labor Drug: Nifedipine Drug: Placebo Other: Usual care Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Nifedipine for Acute Tocolysis of Preterm Labor
Actual Study Start Date : May 5, 2014
Actual Primary Completion Date : October 29, 2018
Actual Study Completion Date : October 29, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Nifedipine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Nifedipine
Women with preterm labor will receive nifedipine.
 Drug: Nifedipine
Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.

Other: Usual care
Usual evaluation, monitoring and care for women with preterm labor.
Experimental: Placebo
Women with preterm labor will receive placebo.
 Drug: Placebo
Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.

Other: Usual care
Usual evaluation, monitoring and care for women with preterm labor.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Preterm Birth [ Time Frame: Less than 37 weeks of gestation ]

Secondary Outcome Measures :
  1. Number of Participants With Preterm Birth [ Time Frame: Within 48 hours of randomization ]
  2. Number of Participants With Preterm Birth [ Time Frame: At least 2 doses of betamethasone administered prior to delivery ]
  3. Number of Participants With Preterm Birth [ Time Frame: Within 7 days of randomization ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 44 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between 16 and 44 years of age inclusive
  • Singleton pregnancy
  • Intact membranes
  • Between 28-0/7 weeks and 33-6/7 weeks' gestation inclusive
  • Reported or documented uterine activity
  • Cervical dilation between 2 cm and 4 cm inclusive

Exclusion Criteria:

  • Multifetal gestation
  • Less than 28 weeks' gestation
  • 34 or more weeks' gestation
  • Ruptured membranes
  • More than 4 cm dilated
  • Previously received a course of corticosteroids for fetal lung maturation
  • Oligohydramnios
  • Fetal growth restriction
  • Chorioamnionitis or temperature of at least 38.0 degrees Celsius
  • Fetal death
  • Preeclampsia
  • Suspected placental abruption or placenta previa
  • Lethal fetal malformation or amniotic fluid index at least 35
  • Systolic BP < 90 mmHg or diastolic BP < 50 mmHg
  • Baseline tachycardia (pulse >120 after 2 consecutive measurements 30 minutes apart)
  • Chronic hypertension treated with antihypertensives in pregnancy
  • Seizure disorder or HIV
  • Maternal allergy to nifedipine
  • Known maternal cardiac disease
  • Women who have received progesterone therapy in the second or third trimester for prevention of preterm birth
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): NCT02132533


Locations
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United States, Texas
Parkland Memorial Hospital
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Study Director: Brian M Casey, MD Department of Alabama Medical Center, Birmingham, AL
Study Director: Donald D McIntire, PhD University of Texas Southwestern Medical Center
Study Director: Kenneth J Leveno, MD University of Texas Southwestern Medical Center
Study Director: Chet E Wells, MD University of Texas Southwestern Medical Center
Principal Investigator: Josiah S Hawkins, MD Kaiser Medical Center, Oakland, CA
  Study Documents (Full-Text)

Documents provided by University of Texas Southwestern Medical Center:
Study Protocol and Statistical Analysis Plan  [PDF] March 22, 2018

More Information
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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02132533    
Other Study ID Numbers: 122013-063
First Posted: May 7, 2014    Key Record Dates
Results First Posted: February 21, 2020
Last Update Posted: December 21, 2020
Last Verified: December 2020
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
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