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

NCT03547791 | Completed Phase 2

• 1 other identifier: Twin_RCT_2018
• Study Type: interventional
• Target: 848
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Twin Pregnancy, Antepartum Condition or Complication

Keywords

Antenatal corticosteroid; Twin pregnancies; Respiratory morbidity; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Maternal complication

  72 hours after birth

• Respiratory distress syndrome

  72 hours after birth

• Transient tachypnea of the newborn, apnea

  72 hours after birth

• Need for resuscitation at birth

  at birth

• Surfactant use

  28 days after birth

Other Outcomes (9)

• Necrotizing enterocolitis (NEC)

  28 days after birth

• Birth weight

  at birth

• 1 minute, 5minute Apgar score

  at birth

Study Arms (2)

ACS (Group 1)

ACTIVE COMPARATOR

Intramuscular injection of betamethason sodium phosphate 12mg (3ml) twice 24hours apart

Drug: Betamethason Sodium Phosphate

Placebo (Group 2)

PLACEBO COMPARATOR

Intramuscular injection of normal saline 3ml twice 24hours apart

Drug: Normal saline

Interventions

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.

Also known as: ACS

ACS (Group 1)

Normal saline DRUG

Intramuscular injection of normal saline 3ml twice 24hours apart

Also known as: NS

Placebo (Group 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Age over 18 years
• (2) Twin pregnant women at 34weeks 0days to 36weeks 5days of gestation
• (3) At risk for preterm birth such as preterm labor, preterm prematrue rupture of membrane or maternal-fetal indications that need preterm delivery. Preterm labor is defined as regular uterine contractions with or without the following symptoms; pelvic pressure, backache, increased vaginal discharge, menstrual-like cramps, bleeding/show, cervical changes
• (4) Availability of written informed consent.

You may not qualify if:

• (1) Gestational age before 34weeks 0days or after 36weeks 6days
• (2) Lethal major fetal anomaly, fetal distress or fetal death in utero
• (3) Expected to deliver within 12 hours; for example, advanced cervical dilatation (\>8cm) in preterm labor or active phase labor (cervical dilatation\>4cm) in preterm premature rupture of membranes
• (4) History of a previous administration of ACS before 34weeks of gestation for fetal lung maturation
• (5) Administration of systemic steroid for medical indications
• (6)Diagnosis of clinical chorioamnionitis Fever \>37.8 and the presence of two more following conditions: uterine tenderness, foul-odored vaginal discharge, maternal leukocytosis(\>1500), maternal tachycardia(\>100) or fetal tachycardia(\>160)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (3)

• 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.

  PMID: 40982289 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.

  PMID: 33368142 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.

  PMID: 30943910 DERIVED

MeSH Terms

Interventions

betamethasone sodium phosphate; Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: June 6, 2018
• Study Start: May 5, 2018
• Primary Completion: December 31, 2023
• Study Completion: July 26, 2024
• Last Updated: August 1, 2024

Record last verified: 2024-07

Locations

KR (1)