Nifedipine or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor

October 25, 2021 updated by: Jerrie Refuerzo, The University of Texas Health Science Center, Houston

Nifedipine Alone or Nifedipine Plus Indomethacin for Treatment of Acute Preterm Labor: An Open Label, Randomized Comparative Effectiveness Controlled Trial

Tocolytic agents are used for the treatment of preterm labor. It is unclear whether combination treatments of two tocolytic agents are more effective in stopping preterm labor compared to one. Therefore, the investigators propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators current treatment for preterm labor has not been shown to be effective in prolonging pregnancy sufficiently to improve neonatal outcomes and other treatment strategies are needed. Multiple examples demonstrate that multi-agent treatments are routine clinical practice in other fields of medicine including chemotherapeutics for cancer, multi-therapeutics for myocardial infarction and broad spectrum antibiotics for pneumonia. At this time, it is unclear if a combination of tocolytic medications for preterm labor is more advantageous for women. If pregnancy is prolonged with combined tocolytic therapy, this could directly influence the treatment of preterm labor and potentially improve neonatal outcomes. There currently are no trials of combination regimens using widely used tocolytic agents, such as nifedipine and indomethacin. Thus, we propose a comparative effective trial of nifedipine plus indomethacin vs. nifedipine alone for the treatment of preterm labor

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital Texas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • We will include pregnant women between 22 0/7 to 31 6/7 weeks gestation who present with regular uterine contractions defined as at least one contraction every 10 minutes for 30 minutes with at least one of the following:
  • cervical change of at least 1 cm or
  • cervical dilation of 2 cm at the time of initial exam or
  • positive fetal fibronectin and transvaginal cervical length <2.5 cm

Exclusion Criteria:

  • We will exclude pregnant women with any contraindication to tocolysis:
  • clinical chorioamnionitis (defined as a temperature of >100.4 F and any of the following: fundal tenderness, maternal tachycardia, fetal tachycardia or purulent vaginal discharge)
  • non reassuring fetal heart tones
  • suspected placental abruption
  • preterm premature rupture of membranes
  • prior tocolytic treatment during the past 48 hours
  • known adverse effect to indomethacin or nifedipine
  • already receiving nifedipine for chronic hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Nifedipine
Participants will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours for a total of 48 hours.
Drug: Nifedipine
Other Names:
  • Procardia
Active Comparator: Nifedipine plus Indomethacin
Participants will receive will receive nifedipine 10 mg orally every 20 minutes for 3 doses, then nifedipine 10 mg every 6 hours for a total of 48 hours, as well as indomethacin 100 mg orally, then indomethacin 50 mg orally every 6 hours for a total of 48 hours.
Drug: Nifedipine
Other Names:
  • Procardia
Drug: Indomethacin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of Maternal Participants Who Achieve 48 Hours of Pregnancy Prolongation
Time Frame: 48 hours after administration of tocolytic agent
48 hours after administration of tocolytic agent

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Maternal Participants Who Achieve 7 Days of Pregnancy Prolongation
Time Frame: 7 days after administration of tocolytic agent
7 days after administration of tocolytic agent
Number of Days From First Dose of Tocolytic Agent to Delivery
Time Frame: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Length of time from tocolytic initiation to the time of delivery
from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Neonatal Birthweight
Time Frame: at the time of birth
at the time of birth
Neonatal Sex
Time Frame: at the time of birth
at the time of birth
Number of Neonates Who Were Admitted to the Neonatal Intensive Care Unit (NICU)
Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
from birth until hospital discharge or day 120 of life (whichever occurs first)
Neonatal Length of Stay in NICU
Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
from birth until hospital discharge or day 120 of life (whichever occurs first)
Neonatal Length of Hospital Stay
Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonatal Deaths
Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonates With Intraventricular Hemorrhage Diagnosed Using Cranial Ultrasonography
Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonates With Necrotizing Enterocolitis
Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonates With Culture-positive Sepsis
Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonates With Seizures
Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonates Who Needed Mechanical Ventilation
Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
from birth until hospital discharge or day 120 of life (whichever occurs first)
Neonatal Duration of Ventilator Use
Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Neonates Who Received Continuous Positive Airway Pressure (CPAP)
Time Frame: from birth until hospital discharge or day 120 of life (whichever occurs first)
from birth until hospital discharge or day 120 of life (whichever occurs first)
Number of Maternal Participants Who Delivered by Cesarean Delivery
Time Frame: at the the time of birth
at the the time of birth
Number of Maternal Participants Who Had Clinical Chorioamnionitis
Time Frame: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Number of Maternal Participants Who Had Preterm Premature Rupture of Membranes (PPROM)
Time Frame: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Number of Maternal Participants Who Had Preeclampsia
Time Frame: from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
from time of tocolytic initiation to the time of delivery (from about 1 day to about 2 months)
Number of Maternal Participants Who Needed Blood Transfusion
Time Frame: from time of birth to time of discharge from hospital (about 2-3 days)
from time of birth to time of discharge from hospital (about 2-3 days)
Number of Maternal Participants With Headache
Time Frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Number of Maternal Participants With Nausea
Time Frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Number of Maternal Participants With Vomiting
Time Frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Number of Maternal Participants With Acid Reflux
Time Frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Number of Maternal Participants With Hypotension
Time Frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Number of Maternal Participants With Tachycardia
Time Frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
Number of Maternal Participants With Syncope
Time Frame: from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)
from time of tocolytic initiation to the time of hospital discharge (from about 2 days to about 2 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Maria Hutchinson, M.S., The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-15-0134

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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