Nifedipine for Acute Tocolysis of Preterm Labor

• Status: Completed
• Trial end date: 2018-10-29
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Nifedipine

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