NCT03547791

Effects of ACS in Twin With LPB: Study Protocol for a RCT

Completed Phase 2, PHASE3 Last updated 1 August 2024

What this trial tests

Phase 2, PHASE3 trial testing Betamethason Sodium Phosphate in Twin Pregnancy, Antepartum Condition or Complication in 848 participants. Completed in 26 July 2024.

Timeline

5 May 2018

Primary endpoint
31 December 2023

26 July 2024

Quick facts

Lead sponsor	Seoul National University Hospital
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	848
Start date	5 May 2018
Primary completion	31 December 2023
Estimated completion	26 July 2024
Sites	1 location across South Korea

Drugs / interventions tested

• Betamethason Sodium Phosphate — full drug profile →
• Normal saline

Conditions studied

• Twin Pregnancy, Antepartum Condition or Complication — all drugs for Twin Pregnancy, Antepartum Condition or Complication →

Sponsor

Seoul National University Hospital

Who can join

18 and older, female only, with Twin Pregnancy, Antepartum Condition or Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will be the first study that evaluates the effectiveness of antenatal corticosteroid (ACS) in late preterm twin neonates.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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 S, Lee SM, Kwak DW, Lee J, et al · · 2019 · cited 17× · PMID 30943910 · DOI 10.1186/s12884-019-2235-5
2. Antenatal Corticosteroid in Twin-Pregnant Women at Risk of Late Preterm Delivery: A Randomized Clinical Trial.
   Lee SM, Park HS, Choi SR, Lee J, et al · · 2025 · cited 4× · PMID 40982289 · DOI 10.1001/jamapediatrics.2025.3284