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

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: Completed
• Conditions: Premature Birth
• Intervention / Treatment: Drug: Betamethasone - ACTIVE; Other: Normal Saline - PLACEBO

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
• Enrollment (Actual): 194
• Phase: Phase 2; Phase 3

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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: 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

Outcome Measure	Measure Description	Time Frame
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.	from birth through the first 28 days of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational age of baby	gestational age of the baby on the day of it's birth	measured within the first 24 hours following birth.
Baby's birth weight	weight of the baby taken with in the first hours following birth	measured within the first 24 hours following birth
Intrauterine growth restriction (IUGR)	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	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	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	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	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	the number of days that newborn remains in the hospital following its birth.	measured within the first 24 hours following birth
Pneumothorax	diagnosis of a collapsed lung supported by clinical or radiologic evidence.	measured within the first 24 hours following birth
Maternal Infectious Morbidity	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	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

• Sponsor: Pediatrix
• Investigators: Principal Investigator: Richard Porreco, MD, Pediatrix

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2016
• Primary Completion (Actual): August 15, 2022
• Study Completion (Actual): October 31, 2022

Study Registration Dates

• First Submitted: June 5, 2015
• First Submitted That Met QC Criteria: June 8, 2015
• First Posted (Estimate): June 11, 2015

Study Record Updates

• Last Update Posted (Estimate): December 15, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Rupture; Premature Birth; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anti-Asthmatic Agents; Respiratory System Agents; Dexamethasone; Betamethasone
• Other Study ID Numbers: OBX0034

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No