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

Subeen Hong, Seung Mi Lee, Dong Wook Kwak, Joongyub Lee, So Yeon Kim, Jeong Won Oh, Sohee Oh, Chan-Wook Park, Joong Shin Park, Jin Hoon Chung, Jong Kwan Jun, Subeen Hong, Seung Mi Lee, Dong Wook Kwak, Joongyub Lee, So Yeon Kim, Jeong Won Oh, Sohee Oh, Chan-Wook Park, Joong Shin Park, Jin Hoon Chung, Jong Kwan Jun

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).

Keywords: Antenatal corticosteroids; Late preterm birth; Randomized controlled trial; Respiratory morbidity; Twin pregnancies.

Conflict of interest statement

Ethics approval and consent to participate

This study is approved by the Institutional Review Board of Seoul National University Hospital (C-1710-063-89), Cheil General Hospital and Women’s Healthcare Center (CGH-IRB-2017-42), and Ministry of Food and Drug Safety in Korea, and is registered at Consent for publication

Not applicable.

Competing interests

None of the authors have any conflict of interest.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Study flow chart. PTL, preterm labour; PPROM, preterm premature rupture of membranes; M-F indication, maternal foetal indication; IM, intramuscular

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