Nifedipine for Acute Tocolysis of Preterm Labor (Nifedipine)

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.

Study Overview

• Status: Completed
• Conditions: Preterm Labor
• Intervention / Treatment: Drug: Nifedipine; Other: Usual care; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Parkland Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 44 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nifedipine; Women with preterm labor will receive nifedipine.	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.; Other: Usual care; Usual evaluation, monitoring and care for women with preterm labor.
Experimental: Placebo; Women with preterm labor will receive placebo.	Other: Usual care; Usual evaluation, monitoring and care for women with preterm labor.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Preterm Birth	Less than 37 weeks of gestation

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Preterm Birth	Within 48 hours of randomization
Number of Participants With Preterm Birth	At least 2 doses of betamethasone administered prior to delivery
Number of Participants With Preterm Birth	Within 7 days of randomization

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Study Director: Brian M Casey, MD, Department of Alabama Medical Center, Birmingham, AL; Study Director: Donald D McIntire, PhD, University of Texas Southwestern Medical Center; Study Director: Kenneth J Leveno, MD, University of Texas Southwestern Medical Center; Study Director: Chet E Wells, MD, University of Texas Southwestern Medical Center; Principal Investigator: Josiah S Hawkins, MD, Kaiser Medical Center, Oakland, CA

Publications and helpful links

General Publications

• Wilson A, Hodgetts-Morton VA, Marson EJ, Markland AD, Larkai E, Papadopoulou A, Coomarasamy A, Tobias A, Chou D, Oladapo OT, Price MJ, Morris K, Gallos ID. Tocolytics for delaying preterm birth: a network meta-analysis (0924). Cochrane Database Syst Rev. 2022 Aug 10;8(8):CD014978. doi: 10.1002/14651858.CD014978.pub2.
• Hawkins JS, Wells CE, Casey BM, McIntire DD, Leveno KJ. Nifedipine for Acute Tocolysis of Preterm Labor: A Placebo-Controlled Randomized Trial. Obstet Gynecol. 2021 Jul 1;138(1):73-78. doi: 10.1097/AOG.0000000000004436.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2014
• Primary Completion (Actual): October 29, 2018
• Study Completion (Actual): October 29, 2018

Study Registration Dates

• First Submitted: April 30, 2014
• First Submitted That Met QC Criteria: May 6, 2014
• First Posted (Estimate): May 7, 2014

Study Record Updates

• Last Update Posted (Actual): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Premature Birth; Obstetric Labor, Premature; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Membrane Transport Modulators; Calcium-Regulating Hormones and Agents; Reproductive Control Agents; Calcium Channel Blockers; Tocolytic Agents; Nifedipine
• Other Study ID Numbers: 122013-063