Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
88 participants
INTERVENTIONAL
2014-05-05
2018-10-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Nifedipine
Women with preterm labor will receive nifedipine.
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.
Usual care
Usual evaluation, monitoring and care for women with preterm labor.
Placebo
Women with preterm labor will receive placebo.
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.
Usual care
Usual evaluation, monitoring and care for women with preterm labor.
Interventions
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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.
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.
Usual care
Usual evaluation, monitoring and care for women with preterm labor.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
44 Years
FEMALE
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Principal Investigators
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Brian M Casey, MD
Role: STUDY_DIRECTOR
Department of Alabama Medical Center, Birmingham, AL
Donald D McIntire, PhD
Role: STUDY_DIRECTOR
University of Texas Southwestern Medical Center
Kenneth J Leveno, MD
Role: STUDY_DIRECTOR
University of Texas Southwestern Medical Center
Chet E Wells, MD
Role: STUDY_DIRECTOR
University of Texas Southwestern Medical Center
Josiah S Hawkins, MD
Role: PRINCIPAL_INVESTIGATOR
Kaiser Medical Center, Oakland, CA
Locations
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Parkland Memorial Hospital
Dallas, Texas, United States
Countries
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References
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Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
Hawkins JS, Wells CE, Casey BM, McIntire DD, Leveno KJ. Nifedipine for Acute Tocolysis of Preterm Labor: A Placebo-Controlled Randomized Trial. Obstet Gynecol. 2021 Jul 1;138(1):73-78. doi: 10.1097/AOG.0000000000004436.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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122013-063
Identifier Type: -
Identifier Source: org_study_id