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

Seoul National University Hospital848 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

848

Conditions

Twin Pregnancy, Antepartum Condition or Complication

Interventions

Betamethason Sodium PhosphateDRUG

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.

Normal salineDRUG

Intramuscular injection of normal saline 3ml twice 24hours apart

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Incidence of respiratory morbidity

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

Time frame: 72 hours after birth

Secondary Outcomes

Maternal complication

Chorioamnionitis and Postpartum endometritis

Time frame: 72 hours after birth

Respiratory distress syndrome

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

Time frame: 72 hours after birth

Transient tachypnea of the newborn, apnea

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

Time frame: 72 hours after birth

Need for resuscitation at birth

any intervention in the first 30 minutes other than blow-by oxygen

Time frame: at birth

Surfactant use

Time frame: 28 days after birth

Bronchopulmonary dysplasia;BPD

Requirement for supplemental oxygen with a fraction of inspired oxygen of more than 0.21 for the first 28 days of life

Data from ClinicalTrials.gov

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