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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

848 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-05

Study Completion Date

2024-07-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Antenatal Corticosteroid Therapy: Which Impact on Birth Parameters?

NCT05640596

Growth Retardation

COMPLETED

Metformin to Prevent Preterm Birth in Twin Pregnancy

NCT05412056

Preterm Birth Premature Obstetric Labor Twin; Complicating Pregnancy +4 more

UNKNOWN PHASE2/PHASE3

Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)

NCT00187382

Pregnancies at Increased Risk of Preterm Birth

COMPLETED PHASE4

Dose Reduction of Antenatal Betamethasone Given to Prevent the Neonatal Complications Associated With Very Preterm Birth

NCT02897076

Neonatal Complications

COMPLETED PHASE3

Does a Rescue Course of Betamethasone in Pregnant Women With PPROM Decrease Neonatal Morbidity?

NCT02939742

PPROM Respiratory Distress Syndrome in Premature Infants

TERMINATED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Twin Pregnancy, Antepartum Condition or Complication

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ACS (Group 1)

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

Group Type ACTIVE_COMPARATOR

Betamethason Sodium Phosphate

Intervention Type 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.

Placebo (Group 2)

Intramuscular injection of normal saline 3ml twice 24hours apart

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Intramuscular injection of normal saline 3ml twice 24hours apart

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Betamethason Sodium Phosphate

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.

Intervention Type DRUG

Normal saline

Intramuscular injection of normal saline 3ml twice 24hours apart

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ACS NS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* (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.

Exclusion Criteria

* (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)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes