Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes (ACSinPROM)

December 14, 2022 updated by: Pediatrix

A Randomized Double-blinded Trial Comparing the Impact of One Versus Two Courses of Antenatal Steroids on Neonatal Outcome in the Patient With Prelabor Premature Rupture of the Membranes

This trial hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor premature rupture of the membranes.

Study Overview

Status

Status

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

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

This is a multicenter randomized double blinded trial that hopes to prospectively evaluate the impact of one versus two courses of antenatal steroids on the incidence of major neonatal morbidity including respiratory distress syndrome in pregnant women with a singleton gestation between 24w0d - 32w6d gestation who have documented premature rupture of the membranes.

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.
194

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 2
  • Phase 3

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
    • Alabama
      • Mobile, Alabama, United States, 36617
        • University of South Alabama Medical Center
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Phoenix Perinatal Associates
    • California
      • Long Beach, California, United States, 90801-1428
        • Long Beach Memorial Medical Center
      • San Jose, California, United States, 95008
        • Good Samaritan Hospital
    • Colorado
      • Denver, Colorado, United States, 80218
        • Presbyterian/St Luke's Hospital
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • Shreveport, Louisiana, United States, 60612
        • Lousiana State University Health Science
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • University of Tennessee Medical Center
    • Washington
      • Seattle, Washington, United States, 98122-4307
        • Swedish 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

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Participants age 18 years or older
  • 24w0d to 32w6d weeks gestation
  • Singleton pregnancy
  • Received first course of ACS at or prior to 31w6d gestation
  • Began first course of ACS at least 7 days ( =/> 168 hours) prior to randomization
  • Expectant management planned
  • Premature Ruptured membranes (PROM) before onset of labor

Exclusion Criteria:

  • Known major fetal anomalies
  • Multiple gestation
  • Not a candidate for expectant management
  • Clinical chorioamnionitis (two or more of the following: temperature > 38.0 degrees centigrade; uterine tenderness; foul smelling vaginal discharge or amniotic fluid; maternal tachycardia >100 bpm; fetal tachycardia >160 bpm; maternal White Blood Cell (WBC) count >20 X 109/L; C-Reactive Protein (CRP) > 5.9
  • Already receiving corticosteroids for another condition
  • Any contraindications to the maternal use of corticosteroids

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: Quadruple

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.
Experimental: Betamethasone - ACTIVE
Booster Course of Antenatal Steroids consists of Betamethasone [12 mg intramuscular injection, 24 hours apart X 2 doses] or if unavailable may give Dexamethasone [6 mg intramuscularly 12 hours apart x 4 doses]
Drug: Betamethasone - ACTIVE
antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses.
Other Names:
  • dexamethasone
  • antenatal corticosteroid
Placebo Comparator: normal saline - PLACEBO
Normal saline of equivalent volume given intramuscularly at the equivalent dosing regimes listed in experimental arm.
Other: Normal Saline - PLACEBO
normal saline of the same quantity as with the experimental drug is to be given by injection 24 hours apart for two doses
Other Names:
  • NS

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
Measure Description
Time Frame
Composite Neonatal Morbidity
Time Frame: from birth through the first 28 days of life
Composite Neonatal Morbidity includes any one or more of the following: respiratory distress syndrome, bronchopulmonary dysplasia, severe intraventricular hemorrhage, periventricular leukomalacia, proven sepsis, necrotizing enterocolitis, or neonatal death.
from birth through the first 28 days of life

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
Gestational age of baby
Time Frame: measured within the first 24 hours following birth.
gestational age of the baby on the day of it's birth
measured within the first 24 hours following birth.
Baby's birth weight
Time Frame: measured within the first 24 hours following birth
weight of the baby taken with in the first hours following birth
measured within the first 24 hours following birth
Intrauterine growth restriction (IUGR)
Time Frame: anytime during the pregnancy prior to birth (~ 9 months of pregnancy)
a measurement done by ultrasound taken at any time during the pregnancy prior to birth
anytime during the pregnancy prior to birth (~ 9 months of pregnancy)
Baby's Head Circumference
Time Frame: measured within the first 24 hours following birth
a measurement of the baby's head taken within the first hours following birth
measured within the first 24 hours following birth
Newborn Mechanical Ventilatory days
Time Frame: measured from birth to 28 days following birth
measurement of the total number of days the baby requires mechanical ventilatory support
measured from birth to 28 days following birth
Newborn Oxygen support days
Time Frame: measured from birth to 28 days following birth
measurement of the total number of days the baby requires oxygen support (example: nasal cannula, CPAP)
measured from birth to 28 days following birth
Newborn Surfactant therapy
Time Frame: measured within the first 24 hours following birth
measurement of the need for newborn surfactant therapy within the first 28 day following birth
measured within the first 24 hours following birth
Newborn Hospital Days
Time Frame: measured within the first 24 hours following birth
the number of days that newborn remains in the hospital following its birth.
measured within the first 24 hours following birth
Pneumothorax
Time Frame: measured within the first 24 hours following birth
diagnosis of a collapsed lung supported by clinical or radiologic evidence.
measured within the first 24 hours following birth
Maternal Infectious Morbidity
Time Frame: measured within the first 24 hours following birth
diagnosis of maternal infection for example; chorioamnionitis, endometritis or postoperative wound infection.
measured within the first 24 hours following birth
time from first dose of study drug to birth
Time Frame: measured in days/hours from the time of administration of first study drug until birth.
the number of hours/days from the time of the first dose of study drug until birth
measured in days/hours from the time of administration of first study drug until birth.

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.
Pediatrix

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.
  • Principal Investigator: Richard Porreco, MD, Pediatrix

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.
March 3, 2016

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.
August 15, 2022

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 31, 2022

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).
June 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.
June 8, 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.
June 11, 2015

Study Record Updates

Last Update Posted (Estimate)

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.
December 15, 2022

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.
December 14, 2022

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.
December 1, 2022

More Information

Terms related to this study

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.
  • OBX0034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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