Effects of Antenatal Corticosteroid in Twin Neonates With Late Preterm Birth: Study Protocol for a Randomized Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Betamethason Sodium Phosphate
- Conditions
- Twin Pregnancy, Antepartum Condition or Complication
- Sponsor
- Seoul National University Hospital
- Enrollment
- 848
- Locations
- 1
- Primary Endpoint
- Incidence of respiratory morbidity
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This study will be the first study that evaluates the effectiveness of antenatal corticosteroid (ACS) in late preterm twin neonates.
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.
Investigators
Eligibility Criteria
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)
Arms & Interventions
ACS (Group 1)
Intramuscular injection of betamethason sodium phosphate 12mg (3ml) twice 24hours apart
Intervention: Betamethason Sodium Phosphate
Placebo (Group 2)
Intramuscular injection of normal saline 3ml twice 24hours apart
Intervention: Normal saline
Outcomes
Primary Outcomes
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 Outcomes
- Surfactant use(28 days after birth)
- Transient tachypnea of the newborn, apnea(72 hours after birth)
- Bronchopulmonary dysplasia;BPD(28 days after birth)
- Respiratory distress syndrome(72 hours after birth)
- Maternal complication(72 hours after birth)
- Need for resuscitation at birth(at birth)