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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 2022

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.

Interventions

  • Drug: Betamethasone – ACTIVE
    • antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses.
  • 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

Arms, Groups and Cohorts

  • 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]
  • Placebo Comparator: normal saline – PLACEBO
    • Normal saline of equivalent volume given intramuscularly at the equivalent dosing regimes listed in experimental arm.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Mednax Center for Research, Education, Quality and Safety
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Richard Porreco, MD, Principal Investigator, Mednax Center for Research, Education, Quality and Safety
  • Overall Contact(s)
    • Kimberly Maurel, MSN, 7145939171, kimberly_maurel@mednax.com

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