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Nifedipine for Acute Tocolysis of Preterm Labor (Nifedipine)

Primary Purpose

Preterm Labor

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nifedipine
Placebo
Usual care
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Preterm Labor

Eligibility Criteria

16 Years - 44 Years (Child, Adult)FemaleDoes not accept 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

Sites / Locations

  • Parkland Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Nifedipine

Placebo

Arm Description

Women with preterm labor will receive nifedipine.

Women with preterm labor will receive placebo.

Outcomes

Primary Outcome Measures

Number of Participants With Preterm Birth

Secondary Outcome Measures

Number of Participants With Preterm Birth
Number of Participants With Preterm Birth
Number of Participants With Preterm Birth

Full Information

First Posted
April 30, 2014
Last Updated
December 17, 2020
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02132533
Brief Title
Nifedipine for Acute Tocolysis of Preterm Labor
Acronym
Nifedipine
Official Title
Nifedipine for Acute Tocolysis of Preterm Labor
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 5, 2014 (Actual)
Primary Completion Date
October 29, 2018 (Actual)
Study Completion Date
October 29, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Labor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nifedipine
Arm Type
Experimental
Arm Description
Women with preterm labor will receive nifedipine.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Women with preterm labor will receive placebo.
Intervention Type
Drug
Intervention Name(s)
Nifedipine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual evaluation, monitoring and care for women with preterm labor.
Primary Outcome Measure Information:
Title
Number of Participants With Preterm Birth
Time Frame
Less than 37 weeks of gestation
Secondary Outcome Measure Information:
Title
Number of Participants With Preterm Birth
Time Frame
Within 48 hours of randomization
Title
Number of Participants With Preterm Birth
Time Frame
At least 2 doses of betamethasone administered prior to delivery
Title
Number of Participants With Preterm Birth
Time Frame
Within 7 days of randomization

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian M Casey, MD
Organizational Affiliation
Department of Alabama Medical Center, Birmingham, AL
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Donald D McIntire, PhD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kenneth J Leveno, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chet E Wells, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Josiah S Hawkins, MD
Organizational Affiliation
Kaiser Medical Center, Oakland, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35947046
Citation
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.
Results Reference
derived
PubMed Identifier
34259466
Citation
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.
Results Reference
derived

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Nifedipine for Acute Tocolysis of Preterm Labor

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