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

Primary Purpose

Premature Birth

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Betamethasone - ACTIVE
Normal Saline - PLACEBO
Sponsored by
Pediatrix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Birth

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of South Alabama Medical Center
  • Phoenix Perinatal Associates
  • Long Beach Memorial Medical Center
  • Good Samaritan Hospital
  • Presbyterian/St Luke's Hospital
  • Ochsner Clinic Foundation
  • Lousiana State University Health Science
  • University of Tennessee Medical Center
  • Swedish Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Betamethasone - ACTIVE

normal saline - PLACEBO

Arm Description

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]

Normal saline of equivalent volume given intramuscularly at the equivalent dosing regimes listed in experimental arm.

Outcomes

Primary Outcome Measures

Composite Neonatal Morbidity
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

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

Full Information

First Posted
June 5, 2015
Last Updated
December 14, 2022
Sponsor
Pediatrix
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1. Study Identification

Unique Protocol Identification Number
NCT02469519
Brief Title
Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes
Acronym
ACSinPROM
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2016 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pediatrix

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Betamethasone - ACTIVE
Arm Type
Experimental
Arm Description
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]
Arm Title
normal saline - PLACEBO
Arm Type
Placebo Comparator
Arm Description
Normal saline of equivalent volume given intramuscularly at the equivalent dosing regimes listed in experimental arm.
Intervention Type
Drug
Intervention Name(s)
Betamethasone - ACTIVE
Other Intervention Name(s)
antenatal corticosteroid, dexamethasone
Intervention Description
antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses.
Intervention Type
Other
Intervention Name(s)
Normal Saline - PLACEBO
Other Intervention Name(s)
NS
Intervention Description
normal saline of the same quantity as with the experimental drug is to be given by injection 24 hours apart for two doses
Primary Outcome Measure Information:
Title
Composite Neonatal Morbidity
Description
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.
Time Frame
from birth through the first 28 days of life
Secondary Outcome Measure Information:
Title
Gestational age of baby
Description
gestational age of the baby on the day of it's birth
Time Frame
measured within the first 24 hours following birth.
Title
Baby's birth weight
Description
weight of the baby taken with in the first hours following birth
Time Frame
measured within the first 24 hours following birth
Title
Intrauterine growth restriction (IUGR)
Description
a measurement done by ultrasound taken at any time during the pregnancy prior to birth
Time Frame
anytime during the pregnancy prior to birth (~ 9 months of pregnancy)
Title
Baby's Head Circumference
Description
a measurement of the baby's head taken within the first hours following birth
Time Frame
measured within the first 24 hours following birth
Title
Newborn Mechanical Ventilatory days
Description
measurement of the total number of days the baby requires mechanical ventilatory support
Time Frame
measured from birth to 28 days following birth
Title
Newborn Oxygen support days
Description
measurement of the total number of days the baby requires oxygen support (example: nasal cannula, CPAP)
Time Frame
measured from birth to 28 days following birth
Title
Newborn Surfactant therapy
Description
measurement of the need for newborn surfactant therapy within the first 28 day following birth
Time Frame
measured within the first 24 hours following birth
Title
Newborn Hospital Days
Description
the number of days that newborn remains in the hospital following its birth.
Time Frame
measured within the first 24 hours following birth
Title
Pneumothorax
Description
diagnosis of a collapsed lung supported by clinical or radiologic evidence.
Time Frame
measured within the first 24 hours following birth
Title
Maternal Infectious Morbidity
Description
diagnosis of maternal infection for example; chorioamnionitis, endometritis or postoperative wound infection.
Time Frame
measured within the first 24 hours following birth
Title
time from first dose of study drug to birth
Description
the number of hours/days from the time of the first dose of study drug until birth
Time Frame
measured in days/hours from the time of administration of first study drug until birth.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Porreco, MD
Organizational Affiliation
Pediatrix
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Alabama Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Phoenix Perinatal Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Long Beach Memorial Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90801-1428
Country
United States
Facility Name
Good Samaritan Hospital
City
San Jose
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Presbyterian/St Luke's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Lousiana State University Health Science
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Tennessee Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4307
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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