Nifedipine for Acute Tocolysis of Preterm Labor

Phase 3

Completed

• Conditions: Preterm Labor
• Interventions: Drug: Placebo; Drug: Nifedipine; Other: Usual care

• Registration Number: NCT02132533
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-30
• Study Start: 2014-05-05
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-07
• Primary Completion: 2018-10-29
• Study Completion: 2018-10-29
• Results First Submitted: 2020-02-07
• Results First Submitted QC: 2020-02-07
• Results First Posted: 2020-02-21
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nifedipine	Usual care	Women with preterm labor will receive nifedipine.
Placebo	Placebo	Women with preterm labor will receive placebo.
Placebo	Usual care	Women with preterm labor will receive placebo.
Nifedipine	Nifedipine	Women with preterm labor will receive nifedipine.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Preterm Birth	Less than 37 weeks of gestation

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Preterm Birth	Within 7 days of randomization

Trial Locations

Locations (1)

Parkland Memorial Hospital; 🇺🇸 Dallas, Texas, United States