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Completed

NCT Number: NCT02132533

Nifedipine for Acute Tocolysis of Preterm Labor

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.

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Key information

Conditions

Preterm Labor Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Age range

16 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Parkland Memorial Hospital

Dallas, Texas, 75390, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Usual Care

Other

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

Primary outcomes

  1. Number of Participants With Preterm Birth

    Time frame: Less than 37 weeks of gestation

Secondary outcomes

  1. Number of Participants With Preterm Birth

    Time frame: Within 48 hours of randomization

  2. Number of Participants With Preterm Birth

    Time frame: At least 2 doses of betamethasone administered prior to delivery

  3. Number of Participants With Preterm Birth

    Time frame: Within 7 days of randomization

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Acronym: Nifedipine

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
May 7, 2014
Registry last updated
Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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