Nifedipine for Acute Tocolysis of Preterm Labor

Preterm Labor Clinical Trial

— Nifedipine  

Official title:

Nifedipine for Acute Tocolysis of Preterm Labor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132533
• Other study ID #: 122013-063
• Status: Completed
• Phase: Phase 3
• Start date: May 5, 2014
• Est. completion date: October 29, 2018

Study information

• Verified date: December 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: October 29, 2018
• Est. primary completion date: October 29, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstetric Labor, Premature
• Premature Birth
• Preterm Labor

Intervention

Drug:
• Nifedipine
Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.
• Placebo
Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.

Other:
• Usual care
Usual evaluation, monitoring and care for women with preterm labor.

Locations

Country	Name	City	State
United States	Parkland Memorial Hospital	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Preterm Birth		Less than 37 weeks of gestation
Secondary	Number of Participants With Preterm Birth		Within 48 hours of randomization
Secondary	Number of Participants With Preterm Birth		At least 2 doses of betamethasone administered prior to delivery
Secondary	Number of Participants With Preterm Birth		Within 7 days of randomization