Twin Pregnancy, Antepartum Condition or ComplicationPhase 2/3NCT03547791
Effects of ACS in Twin With LPB: Study Protocol for a RCT
A Phase 2/3 study testing Betamethason Sodium Phosphate and Normal saline in people with Twin Pregnancy, Antepartum Condition or Complication, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study will be the first study that evaluates the effectiveness of antenatal corticosteroid (ACS) in late preterm twin neonates. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Twin Pregnancy, Antepartum Condition or Complication
- What is being tested?
- Betamethason Sodium Phosphate and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 848 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 May 2018to 26 Jul 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Antenatal Corticosteroid in Twin Neonates With Late Preterm Birth: Study Protocol for a Randomized Controlled Trial
This study will be the first study that evaluates the effectiveness of antenatal corticosteroid (ACS) in late preterm twin neonates.
Read the detailed description
Antenatal corticosteroid (ACS) has been proven to prevent adverse outcomes including respiratory morbidities in preterm neonates before 34 weeks of gestations. Recently, it has been suggested that ACS may be also effective for reduction of respiratory complications in singleton late preterm pregnancies. On the contrary, there is a paucity of information regarding the effectiveness of ACS in twin neonates with late preterm birth, and nowadays guidelines are recommending the use of ACS in twin pregnancies based on the evidences in singleton pregnancies. However, the effect of ACS in twin needs to be determined, because the rate of neonatal morbidities in twin preterm neonates seems to be different from that in singleton neonates. This study aims to determine the effectiveness of ACS in late preterm twin neonates.
- Being tested
- Betamethason Sodium Phosphate, Normal saline
- Keywords
- Antenatal corticosteroid, Twin pregnancies, Respiratory morbidity, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethason Sodium PhosphateDrug
Also called ACS
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.
Normal salineDrug
Also called NS
Intramuscular injection of normal saline 3ml twice 24hours apart
| Study group | Role | What they receive |
|---|---|---|
| ACS (Group 1) | Active comparator | Intramuscular injection of betamethason sodium phosphate 12mg (3ml) twice 24hours apart Receives: Drug: Betamethason Sodium Phosphate |
| Placebo (Group 2) | Placebo comparator | Intramuscular injection of normal saline 3ml twice 24hours apart Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 72 hours after birth
Secondary outcomes (6)
Maternal complication
Chorioamnionitis and Postpartum endometritis
Measured: 72 hours after birth
Respiratory distress syndrome
Presence of clinical signs of respiratory distress (tachypnea, retractions, flaring, grunting, or cyanosis), with a requirement for supplemental oxygen with a fraction of inspired oxygen of more than 0.21 and a chest radiograph showing hypoaeration and reticulogranular infiltrates
Measured: 72 hours after birth
Transient tachypnea of the newborn, apnea
Tachypnea occurred in the absence of chest radiography or with a radiograph that was normal or showed signs of increased perihilar interstitial markings and resolved within 72 hours
Measured: 72 hours after birth
Need for resuscitation at birth
any intervention in the first 30 minutes other than blow-by oxygen
Measured: at birth
Surfactant use
Surfactant use
Measured: 28 days after birth
Bronchopulmonary dysplasia;BPD
Requirement for supplemental oxygen with a fraction of inspired oxygen of more than 0.21 for the first 28 days of life
Measured: 28 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start5 May 2018
- Primary completion31 Dec 2023
- Study completion26 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Twin Pregnancy, Antepartum Condition or ComplicationStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 848 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547791
- Sponsor's protocol ID
- Twin_RCT_2018
- Status last verified
- Jul 2024
- First submitted
- 29 Mar 2018
- Last updated
- 1 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40982289McGoldrick 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.
PubMed 33368142Hong 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.
PubMed 30943910
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antenatal Corticosteroid in Twin Neonates With Late Preterm Birth: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03547791
- Acronym / sponsor ID
- Twin_RCT_2018
- Keywords
- Antenatal corticosteroid, Twin pregnancies, Respiratory morbidity, Randomized controlled trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 848 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 5 May 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 26 Jul 2024 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be the first study that evaluates the effectiveness of antenatal corticosteroid (ACS) in late preterm twin neonates.
Detailed description
Antenatal corticosteroid (ACS) has been proven to prevent adverse outcomes including respiratory morbidities in preterm neonates before 34 weeks of gestations. Recently, it has been suggested that ACS may be also effective for reduction of respiratory complications in singleton late preterm pregnancies. On the contrary, there is a paucity of information regarding the effectiveness of ACS in twin neonates with late preterm birth, and nowadays guidelines are recommending the use of ACS in twin pregnancies based on the evidences in singleton pregnancies. However, the effect of ACS in twin needs to be determined, because the rate of neonatal morbidities in twin preterm neonates seems to be different from that in singleton neonates. This study aims to determine the effectiveness of ACS in late preterm twin neonates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ACS (Group 1) | Active comparator | Drug: Betamethason Sodium PhosphateIntramuscular injection of betamethason sodium phosphate 12mg (3ml) twice 24hours apart |
| Placebo (Group 2) | Placebo comparator | Drug: Normal salineIntramuscular injection of normal saline 3ml twice 24hours apart |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- (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.
Key exclusion criteria (6 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Betamethason Sodium PhosphateAlso: ACSThe 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. | Drug | ACS (Group 1) |
| Normal salineAlso: NSIntramuscular injection of normal saline 3ml twice 24hours apart | Drug | Placebo (Group 2) |
Primary outcome
Incidence of respiratory morbidity
Time frame: 72 hours after birth
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
6 secondary outcomes
Maternal complication
Time frame: 72 hours after birth
Respiratory distress syndrome
Time frame: 72 hours after birth
Transient tachypnea of the newborn, apnea
Time frame: 72 hours after birth
Need for resuscitation at birth
Time frame: at birth
Surfactant use
Time frame: 28 days after birth
Bronchopulmonary dysplasia;BPD
Time frame: 28 days after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Derived from this study: PubMed 40982289Lee 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.
- Derived from this study: PubMed 33368142McGoldrick 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.
- Derived from this study: PubMed 30943910Hong 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.
- Individual participant dataSharing planned: Undecided
Related trials for Twin Pregnancy, Antepartum Condition or Complication
RecruitingObservational study
Role of Doppler Echoflowmetry to Define Risk Factors for the Development of Complications in Twin Pregnancies
Twin Pregnancy, Antepartum Condition or Complication
RecruitingObservational study
Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China
Twin Pregnancy, Antepartum Condition or Complication, Twin to Twin Transfusion as Antepartum Condition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Betamethason Sodium Phosphate and Normal saline in people with Twin Pregnancy, Antepartum Condition or Complication, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of respiratory morbidity (time frame: 72 hours after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03547791, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.