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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.
BMC Pregnancy Childbirth. 2019 Apr 03; 19(1):114.BP

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).

Authors+Show Affiliations

Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea. Department of Obstetrics and Gynecology, Seoul National University Bundang Hospital, Seongnam, Republic of Korea.Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.Department of Obstetrics and Gynecology, Cheil General Hospital and Women's Healthcare Center, Dankook University College of Medicine, Seoul, South Korea. Department of Obstetrics and Gynecology, Ajou University Medical School, Suwon, Korea.Department of Prevention and Management, Inha University Hospital, Incheon, Korea. School of Medicine, Inha University, Incheon, Korea.Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.Department of Biostatistics, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea.Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea.Department of Obstetrics and Gynecology, Cheil General Hospital and Women's Healthcare Center, Dankook University College of Medicine, Seoul, South Korea. sabi0515@hanmail.net.Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, Republic of Korea. jhs0927@snu.ac.kr.

Pub Type(s)

Clinical Trial Protocol
Journal Article
Multicenter Study

Language

eng

PubMed ID

30943910

Citation

Hong, Subeen, et al. "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 and Childbirth, vol. 19, no. 1, 2019, p. 114.
Hong S, Lee SM, Kwak DW, et al. 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;19(1):114.
Hong, S., Lee, S. M., Kwak, D. W., Lee, J., Kim, S. Y., Oh, J. W., Oh, S., Park, C. W., Park, J. S., Chung, J. H., & Jun, J. K. (2019). 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 and Childbirth, 19(1), 114. https://doi.org/10.1186/s12884-019-2235-5
Hong S, et al. 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. PubMed PMID: 30943910.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Hong,Subeen, AU - Lee,Seung Mi, AU - Kwak,Dong Wook, AU - Lee,Joongyub, AU - Kim,So Yeon, AU - Oh,Jeong Won, AU - Oh,Sohee, AU - Park,Chan-Wook, AU - Park,Joong Shin, AU - Chung,Jin Hoon, AU - Jun,Jong Kwan, Y1 - 2019/04/03/ PY - 2018/09/12/received PY - 2019/03/04/accepted PY - 2019/4/5/entrez PY - 2019/4/5/pubmed PY - 2019/8/21/medline KW - Antenatal corticosteroids KW - Late preterm birth KW - Randomized controlled trial KW - Respiratory morbidity KW - Twin pregnancies SP - 114 EP - 114 JF - BMC pregnancy and childbirth JO - BMC Pregnancy Childbirth VL - 19 IS - 1 N2 - 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). SN - 1471-2393 UR - https://www.unboundmedicine.com/medline/citation/30943910/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_ L2 - https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-019-2235-5 DB - PRIME DP - Unbound Medicine ER -