Effects of ACS in Twin With LPB: Study Protocol for a RCT

Overview

This study will be the first study that evaluates the effectiveness of antenatal corticosteroid (ACS) in late preterm twin neonates.

Full Title of Study: “Effects of Antenatal Corticosteroid in Twin Neonates With Late Preterm Birth: Study Protocol for a Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: December 31, 2020

Detailed Description

Antenatal corticosteroid (ACS) has been proven to prevent adverse outcomes including respiratory morbidities in preterm neonates before 34 weeks of gestations. Recently, it has been suggested that ACS may be also effective for reduction of respiratory complications in singleton late preterm pregnancies. On the contrary, there is a paucity of information regarding the effectiveness of ACS in twin neonates with late preterm birth, and nowadays guidelines are recommending the use of ACS in twin pregnancies based on the evidences in singleton pregnancies. However, the effect of ACS in twin needs to be determined, because the rate of neonatal morbidities in twin preterm neonates seems to be different from that in singleton neonates. This study aims to determine the effectiveness of ACS in late preterm twin neonates.

Interventions

  • Drug: Betamethason Sodium Phosphate
    • The antecorticosteroid that will be administered to Group 1 is betamethasone, produced by Dawon Parm(Korea). It contains betamethason sodium phosphate 5.2mg(Betamethasone 4.0mg) in 1 ample(1mL). Each drug is carried in a syringe by pharmacist who does not participate in study after the patient was enrolled in the study and administered to the patient twice 24hours apart.
  • Drug: Normal saline
    • Intramuscular injection of normal saline 3ml twice 24hours apart

Arms, Groups and Cohorts

  • Active Comparator: ACS (Group 1)
    • Intramuscular injection of betamethason sodium phosphate 12mg (3ml) twice 24hours apart
  • Placebo Comparator: Placebo (Group 2)
    • Intramuscular injection of normal saline 3ml twice 24hours apart

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of respiratory morbidity
    • Time Frame: 72 hours after birth
    • NICU admission, Continuous positive airway pressure, High flow nasal cannula for ≥12 continuous hours, Fraction of inspired oxygen of ≥ 0.3, Mechanical ventilation use, ECMO use and Stillbirth or neonatal death within 72hours after death

Secondary Measures

  • Maternal complication
    • Time Frame: 72 hours after birth
    • Chorioamnionitis and Postpartum endometritis
  • Respiratory distress syndrome
    • Time Frame: 72 hours after birth
    • Presence of clinical signs of respiratory distress (tachypnea, retractions, flaring, grunting, or cyanosis), with a requirement for supplemental oxygen with a fraction of inspired oxygen of more than 0.21 and a chest radiograph showing hypoaeration and reticulogranular infiltrates
  • Transient tachypnea of the newborn, apnea
    • Time Frame: 72 hours after birth
    • Tachypnea occurred in the absence of chest radiography or with a radiograph that was normal or showed signs of increased perihilar interstitial markings and resolved within 72 hours
  • Need for resuscitation at birth
    • Time Frame: at birth
    • any intervention in the first 30 minutes other than blow-by oxygen
  • Surfactant use
    • Time Frame: 28 days after birth
    • Surfactant use
  • Bronchopulmonary dysplasia;BPD
    • Time Frame: 28 days after birth
    • Requirement for supplemental oxygen with a fraction of inspired oxygen of more than 0.21 for the first 28 days of life

Participating in This Clinical Trial

Inclusion Criteria

  • (1) Age over 18 years
  • (2) Twin pregnant women at 34weeks 0days to 36weeks 5days of gestation
  • (3) At risk for preterm birth such as preterm labor, preterm prematrue rupture of membrane or maternal-fetal indications that need preterm delivery. Preterm labor is defined as regular uterine contractions with or without the following symptoms; pelvic pressure, backache, increased vaginal discharge, menstrual-like cramps, bleeding/show, cervical changes
  • (4) Availability of written informed consent.

Exclusion Criteria

  • (1) Gestational age before 34weeks 0days or after 36weeks 6days
  • (2) Lethal major fetal anomaly, fetal distress or fetal death in utero
  • (3) Expected to deliver within 12 hours; for example, advanced cervical dilatation (>8cm) in preterm labor or active phase labor (cervical dilatation>4cm) in preterm premature rupture of membranes
  • (4) History of a previous administration of ACS before 34weeks of gestation for fetal lung maturation
  • (5) Administration of systemic steroid for medical indications
  • (6)Diagnosis of clinical chorioamnionitis Fever >37.8 and the presence of two more following conditions: uterine tenderness, foul-odored vaginal discharge, maternal leukocytosis(>1500), maternal tachycardia(>100) or fetal tachycardia(>160)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor

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