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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.
Hong, Subeen; Lee, Seung Mi; Kwak, Dong Wook; Lee, Joongyub; Kim, So Yeon; Oh, Jeong Won; Oh, Sohee; Park, Chan-Wook; Park, Joong Shin; Chung, Jin Hoon; Jun, Jong Kwan.
Afiliação
  • Hong S; Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.
  • Lee SM; Department of Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.
  • Kwak DW; Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.
  • Lee J; Department of Obstetrics and Gynecology, Cheil General Hospital and Women's Healthcare Center, Dankook University College of Medicine, Seoul, South Korea.
  • Kim SY; Department of Obstetrics and Gynecology, Ajou University Medical School, Suwon, Korea.
  • Oh JW; Department of Prevention and Management, Inha University Hospital, Incheon, Korea.
  • Oh S; School of Medicine, Inha University, Incheon, Korea.
  • Park CW; Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.
  • Park JS; Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.
  • Chung JH; Department of Biostatistics, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea.
  • Jun JK; Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.
BMC Pregnancy Childbirth ; 19(1): 114, 2019 Apr 03.
Article em En | MEDLINE | ID: mdl-30943910
ABSTRACT

BACKGROUND:

Antenatal corticosteroids have been proven to prevent adverse outcomes including respiratory morbidities in preterm neonates before 34 weeks of gestation. Recently, it has been suggested that antenatal corticosteroids may also be effective in singleton late preterm pregnancies, and guidelines recommend the use of corticosteroids in singleton pregnant women who are at risk for late preterm birth. On the contrary, there is a paucity of information regarding the effectiveness of corticosteroids in twin neonates with late preterm birth. This study aims to determine the effectiveness of antenatal corticosteroids in late preterm twin neonates.

METHODS:

In this multicentre randomized controlled trial, women who are at risk for late preterm birth will be enrolled at 34 0/7 to 36 5/7 weeks of gestation. The participants will be randomly assigned to receive antenatal corticosteroids (betamethasone 12 mg, 3 mL intramuscularly [IM]) or placebo (normal saline 3 mL IM). The perinatal outcomes will be compared between the two groups of cases. The primary outcome is severe respiratory complications (the use of continuous positive airway pressure or high-flow nasal cannula for at least 12 h, supplemental oxygen administration with a fraction of oxygen 0.3 or more for at least 24 h, mechanical ventilation, or extracorporeal membranes oxygenation) or perinatal death within the first 72 h of delivery. The secondary outcomes are neonatal mortality and/or other neonatal morbidities.

DISCUSSION:

This study will be the first randomized controlled trial that evaluates the effectiveness of antenatal corticosteroids in late preterm twin neonates. TRIAL REGISTRATION NCT03547791 (ClinicalTrials.gov), first submitted date March 29, 2018, first posted date June 6, 2018 (retrospectively registered).
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Síndrome do Desconforto Respiratório do Recém-Nascido / Betametasona / Corticosteroides / Nascimento Prematuro / Doenças em Gêmeos Tipo de estudo: Clinical_trials / Guideline / Qualitative_research Limite: Adult / Female / Humans / Infant / Newborn / Pregnancy Idioma: En Revista: BMC Pregnancy Childbirth Assunto da revista: OBSTETRICIA Ano de publicação: 2019 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Síndrome do Desconforto Respiratório do Recém-Nascido / Betametasona / Corticosteroides / Nascimento Prematuro / Doenças em Gêmeos Tipo de estudo: Clinical_trials / Guideline / Qualitative_research Limite: Adult / Female / Humans / Infant / Newborn / Pregnancy Idioma: En Revista: BMC Pregnancy Childbirth Assunto da revista: OBSTETRICIA Ano de publicação: 2019 Tipo de documento: Article