Phase 3 N=88 Randomized Triple-blind Treatment

Nifedipine for Acute Tocolysis of Preterm Labor

Preterm Labor

Bottom Line

View on ClinicalTrials.gov: NCT02132533 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2020

Primary outcome: Primary: Number of Participants With Preterm Birth — 24; 20 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Nifedipine (Drug); Placebo (Drug); Usual care (Other)
Age: Pediatric, Adult · 16+ yrs
Sex: Female
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Oct 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Preterm Birth	13; 14	—
SECONDARY Number of Participants With Preterm Birth	13; 14	—
SECONDARY Number of Participants With Preterm Birth	13; 14	—
SECONDARY Number of Participants With Preterm Birth	13; 14	—

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.

Eligibility 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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02132533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.