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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACS (Group 1) | Active Comparator | Intramuscular injection of betamethason sodium phosphate 12mg (3ml) twice 24hours apart |
|
| Placebo (Group 2) | Placebo Comparator | Intramuscular injection of normal saline 3ml twice 24hours apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Betamethason Sodium Phosphate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 72 hours after birth |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal complication | Chorioamnionitis and Postpartum endometritis | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Necrotizing enterocolitis (NEC) | meconium plug syndrome or confirmed NEC by pathohistology or operation finding | 28 days after birth |
| Birth weight | neonatal body weight |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40982289 | Derived | Lee SM, Park HS, Choi SR, Lee J, Kim HJ, Park JY, Oh KJ, Cho GJ, Oh MJ, Chung JH, Kim SM, Kim BJ, Kim SY, Hong S, Jung YM, Lee SJ, Seong JS, Kim H, Oh S, Lee J, Jin YR, Kim JH, Cho HY, Park CW, Park JS, Jun JK. Antenatal Corticosteroid in Twin-Pregnant Women at Risk of Late Preterm Delivery: A Randomized Clinical Trial. JAMA Pediatr. 2025 Dec 1;179(12):1275-1282. doi: 10.1001/jamapediatrics.2025.3284. | |
| 33368142 |
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| ID | Term |
|---|---|
| C028994 | betamethasone sodium phosphate |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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In this multi-center, double-blind, randomized, placebo-controlled trial, women who are at risk for late preterm birth (34+0wks-36+5wks) will be enrolled and randomly assigned to two groups receiving betamethasone(ACS) or placebo.
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Enrolled women will be randomly assigned in a 1:1 ratio to ACS (Group 1) or placebo (Group 2). The randomization will be done by web-based randomization system which is operated by medical research collaborating center of Seoul National University Hospital. The ACS or placebo will be prepared by unblended researchers [clinical trial pharmacy]. Unblinded researchers will be designated at the beginning of this trial, and they will not participate in the subsequent process of data management and data analysis. Neither the enrolled pregnant women nor the other investigators (except predeterminate unblinded researchers) will be aware of the result of random assignment.
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| Normal saline | Drug | Intramuscular injection of normal saline 3ml twice 24hours apart |
|
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| 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 | 72 hours after birth |
| Need for resuscitation at birth | any intervention in the first 30 minutes other than blow-by oxygen | at birth |
| Surfactant use | Surfactant use | 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 | 28 days after birth |
| at birth |
| 1 minute, 5minute Apgar score | evaluation(scoring) of neonatal appearance, pulse, grimace, activity, respiration 1 minute and 5minute after birth | at birth |
| Hypoglycemia | Glucose < 40 mg% | 28 days after birth |
| Hyperbilirubinemia | Peak total bilirubin of at least 15 mg% or the use of phototherapy | 28 days after birth |
| Feeding difficulty | Inability to take all feeds (po), i.e. requiring gavage feeds or IV supplementation. In addition, time to first feed (po) will be recorded | 28 days after birth |
| Neonatal infectious morbidity | Sepsis, Suspected sepsis and Pneumonia | 28 days after birth |
| Seizures / encephalopathy | Witnessed seizure | 28 days after birth |
| Hospital day of NICU admission | Includes need for NICU or intermediate care admission and length of stay if admitted | 28 days after birth |
| Derived |
| McGoldrick E, Stewart F, Parker R, Dalziel SR. Antenatal corticosteroids for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database Syst Rev. 2020 Dec 25;12(12):CD004454. doi: 10.1002/14651858.CD004454.pub4. |
| 30943910 | Derived | Hong S, Lee SM, Kwak DW, Lee J, Kim SY, Oh JW, Oh S, Park CW, Park JS, Chung JH, Jun JK. Effects of antenatal corticosteroids in twin neonates with late preterm birth (ACTWIN [Antenatal Corticosteroids in TWIN late preterm neonates] trial): study protocol for a randomized controlled trial. BMC Pregnancy Childbirth. 2019 Apr 3;19(1):114. doi: 10.1186/s12884-019-2235-5. |