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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 birth

At 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

Page last updated: August 23, 2015

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