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

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ClinicalTrials.gov Identifier: NCT02469519
Recruitment Status : Recruiting
First Posted : June 11, 2015
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Premature Birth Drug: Betamethasone - ACTIVE Other: Normal Saline - PLACEBO Phase 2 Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : March 3, 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
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:
  • antenatal corticosteroid
  • dexamethasone

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 Name: NS




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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)

  7. 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

  8. 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.

  9. Pneumothorax [ Time Frame: measured within the first 24 hours following birth ]
    diagnosis of a collapsed lung supported by clinical or radiologic evidence.

  10. 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.

  11. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02469519


Contacts
Contact: Kimberly Maurel, MSN 7145939171 kimberly_maurel@mednax.com
Contact: Barbara Marusiak, RN 480-949-5997 barbara_marusiak@mednax.com

Locations
United States, Alabama
University of South Alabama Medical Center Recruiting
Mobile, Alabama, United States, 36617
Contact: Bassam Rimawi, MD    251-415-1000    brimawi@usouthal.edu   
Contact: Casey Armestead    251-415-1598    marmestead@usouthal.edu   
Principal Investigator: Bassam Rimawi, MD         
United States, Arizona
Phoenix Perinatal Associates Recruiting
Phoenix, Arizona, United States, 85014
Contact: Ana Bodea-Braescu, MSN, MPH    602-614-0488    ana_braescu@pediatrix.com   
Contact: Kevin Huls, MD    480-969-5999    kevin_huls@mednax.com   
Principal Investigator: Kevin Huls, MD         
United States, California
Long Beach Memorial Medical Center Recruiting
Long Beach, California, United States, 90801-1428
Contact: Michael Nageotte, MD    562-933-2730    Michael_nageotte@pediatrix.com   
Contact: Deysi Caballero, LVN    562-933-2730    dcaballero@memorialcare.org   
Principal Investigator: Michael Nageotte, MD         
Good Samaritan Hospital Recruiting
San Jose, California, United States, 95008
Contact: Andrew Combs, MD    408-371-7111    andrew_combs@pediatrix.com   
Contact: Kimberly Mallory, RN    408-371-7111    kimberly_mallory@pediatrix.com   
Principal Investigator: Andrew Combs, MD         
United States, Colorado
Presbyterian/St Luke's Hospital Recruiting
Denver, Colorado, United States, 80218
Contact: Richard Porreco, MD    303-860-9990    richard_porreco@pediatrix.com   
Contact: Julie Rael, RN    303-570-8138    julie_rael@pediatrix.com   
Principal Investigator: Richard Porreco, MD         
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Cathy Garvey    504-894-3039    cathryn.garvey@ochsner.org   
Contact: Sherri Longo, MD    504-842-4151    slongo@ochsner.org   
Principal Investigator: Sherri Longo, MD         
Lousiana State University Health Science Recruiting
Shreveport, Louisiana, United States, 60612
Contact: Teresa Harris, RN    318-675-7298    tharr3@lsuhsc.edu   
Principal Investigator: David Lewis, MD         
United States, Tennessee
University of Tennessee Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
Contact: MaryEllen McNeal, BSN    865-305-8888    mmcneal@utmck.edu   
Principal Investigator: Craig Towers, MD         
United States, Texas
Harris Methodist Hospital - Fort Worth Withdrawn
Fort Worth, Texas, United States, 76104
United States, Washington
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122-4307
Contact: Lan Tran, MD    206-624-7730    lan_tran@mednax.com   
Contact: Dawn Artis, RN    206-954-9617    dawn_artis@pediatrix.com   
Principal Investigator: Lan Tran, MD         
Sponsors and Collaborators
Mednax Center for Research, Education, Quality and Safety
Investigators
Study Director: Thomas J Garite, MD Mednax Center for Research, Education, Quality and Safety
Principal Investigator: Richard Porreco, MD Mednax Center for Research, Education, Quality and Safety

Responsible Party: Mednax Center for Research, Education, Quality and Safety
ClinicalTrials.gov Identifier: NCT02469519     History of Changes
Other Study ID Numbers: OBX0034
First Posted: June 11, 2015    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Premature Birth
Rupture
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Wounds and Injuries
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Dexamethasone
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Asthmatic Agents
Respiratory System Agents