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Trial record 7 of 143 for:    NIFEDIPINE

Comparison of Nifedipine Versus Indomethacin for Acute Preterm Labor

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ClinicalTrials.gov Identifier: NCT03129945
Recruitment Status : Active, not recruiting
First Posted : April 26, 2017
Last Update Posted : October 16, 2018
Sponsor:
Collaborators:
University of California, San Francisco
University of California, Davis
University of California, San Diego
University of California, Los Angeles
Information provided by (Responsible Party):
Judith H Chung, University of California, Irvine

Brief Summary:

The purpose of this research study is to determine the best medication to stop preterm labor. Recent studies have identify nifedipine and indomethacin as the two medications that are most likely to delay delivery for 48 hours, decrease maternal side effects and decrease some complications related to preterm delivery to the neonate. Both of these medications are commonly used to stop pre-term labor, therefore it has become our institution's standard to use these two medications in the setting of preterm labor. There have been limited studies comparing these two medications directly.

A total of 450 participants will be asked to participate across all study sites.


Condition or disease Intervention/treatment Phase
Obstetric Labor, Premature Drug: Nifedipine Drug: Indomethacin Not Applicable

Detailed Description:

There are about 10 million births that occur before 37 weeks (prior to full term gestation) that occur annually worldwide. More than 1 million infants die from complications related to preterm birth. Tocolytics, medications that stop preterm labor, have been well studied. Results regarding prolongation of pregnancy are varied, but tocolytics have been shown to delay delivery for 48 hours, allowing time to administer corticosteroids. ACOG (American Congress of Obstetrics and Gynecologists) recommends giving tocolytics to provide time for corticosteroid administration, transfer to tertiary level care and to allow for magnesium infusion to protect the neonatal brain. Corticosteroid administration when the course is completed (48 hours from first dose) decreases some of the major risks associated with prematurity.

Recent meta-analyses have shown of the commonly used tocolytics, calcium channel blockers and prostaglandin inhibitors ranked consistently among the top three medications in several categories including delaying delivery by 48 hours. There have been only two published randomized control studies to date that have directly compared these two tocolytics. These studies lacked power and standardization to provide clinical guidelines. There is a high neonatal mortality and morbidity along with exceedingly high hospital costs associated with complications related to preterm birth, so it is important to intervene with superior medications. Here the investigators propose a multi institutional (based within the University of California system) randomized controlled study to directly compare nifedipine (most commonly used calcium channel blocker) to indomethacin (most commonly used prostaglandin inhibitor).

Objective:

The Investigator's objective is to compare the prolongation of pregnancy by 48 hours after women are diagnosed with preterm labor prior to 32 weeks gestational age and treated with either nifedipine or indomethacin. Investigators hypothesize that indomethacin will significantly arrest preterm labor by 48 hours in more women compared to nifedipine. The primary outcomes measures will be delaying preterm delivery by 48 hours; secondary outcomes measures will include delay of delivery by 7 days and decreasing delivery before 37 weeks.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Nifedipine Versus Indomethacin for Acute Preterm Labor
Study Start Date : November 2014
Actual Primary Completion Date : April 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Nifedipine
Participants will be given this medication orally
Drug: Nifedipine
Subjects will be given nifedipine 10mg orally and repeated every 20 minutes for a maximum dose of 30mg in the first hour followed by 20mg every 6 hours for the first 48 hours.
Other Name: Procardia

Active Comparator: Indomethacin
Participants will be given this medication orally
Drug: Indomethacin
Those randomized to indomethacin will be given 100mg orally as a loading dose followed by 50mg every 6 hours for the first 48 hours of treatment.
Other Name: Indocin




Primary Outcome Measures :
  1. Delay of preterm delivery by 48 hours [ Time Frame: Participants will be followed for the duration of the hospital stay, an expected average of 1 week ]
    1. To compare the prolongation of pregnancy by 48 hours after women are diagnosed with threatened preterm labor prior to 32 weeks gestational age and treated with either nifedipine or indomethacin. The primary outcome measured will be delay of (preterm delivery) by 48 hours.


Secondary Outcome Measures :
  1. Delay of delivery by 7 days [ Time Frame: Participants will be followed for the duration of the hospital stay, an expected average of 1 week ]
    To compare the prolongation of pregnancy after women are diagnosed with threatened preterm labor prior to 32 weeks gestational age and treated with either nifedipine or indomethacin. The secondary outcome will be the delay of delivery by 7 days

  2. Rate of delivery before 37 weeks gestation [ Time Frame: Participants will be followed for the duration of the hospital stay, an expected average of 1 week ]
    To compare the prolongation of pregnancy after women are diagnosed with threatened preterm labor prior to 32 weeks gestational age and treated with either nifedipine or indomethacin. The secondary outcome will be the rate of delivery before 37 weeks gestation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnancy. A twin pregnancy reduced to singleton (either spontaneously or therapeutically) before 140 weeks by gestational age (see dating below) is acceptable.
  • Gestational age at randomization between 240 weeks to 315 weeks by using the dating determinations as below
  • Preterm labor with intact membranes. Preterm labor is defined as at least 6 regular uterine contractions in 60 minutes either seen on tocodynamometer, palpated by health providers and/or subjectively felt by the patient and at least one of the following:

    1. Associated with cervical change by cervical dilation greater than or equal to 1cm OR effacement greater than or equal to 25 to 50%
    2. Cervix greater than or equal to 2cm dilated on initial digital exam
    3. At least 75% effaced on initial digital exam
    4. Short cervical length (defined by each institution's policy) as obtained by transvaginal cervical sonography [in general, this is defined as a measurement of 2.0 - 2.5 cm or less] and/or a positive fetal fibronectin test (defined as a level greater than 50ng/mL).
  • Intact membranes
  • 18 years of age or older

Exclusion Criteria:

  • Fetal demise, or known major fetal anomaly, including cardiac anomaly and hydrops
  • Maternal contraindication to nifedipine: preload cardiac lesions or maternal hypotension (systolic blood pressure less than 100 or diastolic blood pressure less than 60). A delayed dose can be given if blood pressure improves - it will be documented if dose is delayed, how long from scheduled dose it was delayed and reason for delay.
  • Maternal contraindication to indomethacin: platelet dysfunction or bleeding disorders, hepatic dysfunction, gastrointestinal ulcerative disease, renal dysfunction and asthma
  • Obstetrical contraindication to tocolysis not already mentioned: non reassuring fetal status, severe preeclampsia or eclampsia, maternal bleeding with hemodynamic instability, chorioamnionitis, preterm premature rupture of membranes
  • Participation in another interventional study that influences neonatal morbidity or mortality
  • Participation in this trial earlier in the pregnancy
  • Maternal allergy to either indomethacin or nifedipine
  • Maternal allergy to aspirin and other NSAIDs.
  • Maternal hypertension requiring treatment.
  • Maternal kidney disorder that would require adjustment in magnesium dosing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129945


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
University of California, Irvine
Orange, California, United States, 92868
University of California, Davis
Sacramento, California, United States, 95817
University of California, San Diego
San Diego, California, United States, 92103
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, Irvine
University of California, San Francisco
University of California, Davis
University of California, San Diego
University of California, Los Angeles
Investigators
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Principal Investigator: Deborah A Wing, MD University of California, Irvine
Principal Investigator: Mary Norton, MD University of California, San Francisco
Principal Investigator: Gladys (Sandy) Ramos, MD University of California, San Diego
Principal Investigator: Aisling Murphy, MD University of California, Los Angeles
Principal Investigator: Veronique Tache, MD University of California, Davis

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Responsible Party: Judith H Chung, MD, Professor, Division of Maternal Fetal Medicine, Dept OBGYN, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03129945     History of Changes
Other Study ID Numbers: 2014-1085
UC Reliance 857 ( Other Identifier: University of California )
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Judith H Chung, University of California, Irvine:
Obstetric Labor, Premature
Tocolytic Agents
Additional relevant MeSH terms:
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Nifedipine
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Indomethacin
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors