Nifedipine for Acute Tocolysis of Preterm Labor
Information source: University of Texas Southwestern Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Preterm Labor
Intervention: Nifedipine (Drug); Placebo (Drug); Usual care (Other)
Phase: Phase 3
Status: Recruiting
Sponsored by: University of Texas Southwestern Medical Center Official(s) and/or principal investigator(s): Josiah S Hawkins, MD, Principal Investigator, Affiliation: University of Texas Southwestern Medical Center Brian M Casey, MD, Study Director, Affiliation: University of Texas Southwestern Medical Center Donald D McIntire, PhD, Study Director, Affiliation: University of Texas Southwestern Medical Center Kenneth J Leveno, MD, Study Director, Affiliation: University of Texas Southwestern Medical Center
Overall contact: Josiah S Hawkins, MD, Phone: 214-648-4746, Email: josiah.hawkins@utsouthwestern.edu
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.
Clinical Details
Official title: Nifedipine for Acute Tocolysis of Preterm Labor
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Preterm birth
Secondary outcome: Preterm birthAt least 2 doses of betamethasone administered Preterm birth
Eligibility
Minimum age: 16 Years.
Maximum age: 44 Years.
Gender(s): Female.
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
- Corticosteroids contraindicated per Parkland Hospital protocol
- 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
- 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
Locations and Contacts
Josiah S Hawkins, MD, Phone: 214-648-4746, Email: josiah.hawkins@utsouthwestern.edu
Parkland Memorial Hospital, Dallas, Texas 75390, United States; Recruiting Josiah S Hawkins, MD, Principal Investigator Brian M Casey, MD, Sub-Investigator Kenneth J Leveno, MD, Sub-Investigator
Additional Information
Starting date: May 2014
Last updated: December 12, 2014
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