Nifedipine for Acute Tocolysis of Preterm Labor

The University of Texas System (UT)

Status and phase

Completed

Phase 3

Conditions

Preterm Labor

Treatments

Drug: Nifedipine

Drug: Placebo

Other: Usual care

Study type

Interventional

Funder types

Other

Identifiers

NCT02132533

122013-063

Details and patient eligibility

About

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.

Enrollment

88 patients

Sex

Female

Ages

16 to 44 years old

Volunteers

No Healthy Volunteers

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