Nifedipine for Acute Tocolysis of Preterm Labor

NCT02132533 | Completed Phase 3 Results DMC

• 1 other identifier: 122013-063
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Preterm Labor

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Preterm Birth

  Less than 37 weeks of gestation

Secondary Outcomes (3)

• 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

Study Arms (2)

Nifedipine

EXPERIMENTAL

Women with preterm labor will receive nifedipine.

Drug: Nifedipine; Other: Usual care

Placebo

EXPERIMENTAL

Women with preterm labor will receive placebo.

Drug: Placebo; Other: Usual care

Interventions

Nifedipine DRUG

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.

Nifedipine

Placebo DRUG

Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.

Placebo

Usual care OTHER

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

Nifedipine; Placebo

Eligibility Criteria

• Age: 16 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Multifetal gestation
• Less than 28 weeks' gestation
• 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)

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Memorial Hospital

Dallas, Texas, 75390, United States

Location

Related Publications (2)

• 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.

  PMID: 35947046 DERIVED

• 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.

  PMID: 34259466 DERIVED

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Nifedipine

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chet Edward Wells, MD
• Organization: UT Southwestern Medical Center

dawn.wilson@utsouthwestern.edu

214-648-2316

Study Officials

• 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

  STUDY DIRECTOR

• Josiah S Hawkins, MD

  Kaiser Medical Center, Oakland, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2014
• First Posted: May 7, 2014
• Study Start: May 5, 2014
• Primary Completion: October 29, 2018
• Study Completion: October 29, 2018
• Last Updated: December 21, 2020
• Results First Posted: February 21, 2020

Record last verified: 2020-12

Locations

US (1)