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Completed

NCT Number: NCT03547791

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

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

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Key information

Conditions

Twin Pregnancy, Antepartum Condition or Complication

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: ACS

normal saline

Drug

Intramuscular injection of normal saline 3ml twice 24hours apart

Other names: NS

Primary outcomes

  1. 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

Secondary outcomes

  1. Maternal complication

    Time frame: 72 hours after birth

    Chorioamnionitis and Postpartum endometritis

  2. Respiratory distress syndrome

    Time frame: 72 hours after birth

    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

  3. Transient tachypnea of the newborn, apnea

    Time frame: 72 hours after birth

    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

  4. Need for resuscitation at birth

    Time frame: at birth

    any intervention in the first 30 minutes other than blow-by oxygen

  5. Surfactant use

    Time frame: 28 days after birth

    Surfactant use

  6. Bronchopulmonary dysplasia;BPD

    Time frame: 28 days after birth

    Requirement for supplemental oxygen with a fraction of inspired oxygen of more than 0.21 for the first 28 days of life

Other outcomes

  1. Necrotizing enterocolitis (NEC)

    Time frame: 28 days after birth

    meconium plug syndrome or confirmed NEC by pathohistology or operation finding

  2. Birth weight

    Time frame: at birth

    neonatal body weight

  3. 1 minute, 5minute Apgar score

    Time frame: at birth

    evaluation(scoring) of neonatal appearance, pulse, grimace, activity, respiration 1 minute and 5minute after birth

  4. Hypoglycemia

    Time frame: 28 days after birth

    Glucose < 40 mg%

  5. Hyperbilirubinemia

    Time frame: 28 days after birth

    Peak total bilirubin of at least 15 mg% or the use of phototherapy

  6. Feeding difficulty

    Time frame: 28 days after birth

    Inability to take all feeds (po), i.e. requiring gavage feeds or IV supplementation. In addition, time to first feed (po) will be recorded

  7. Neonatal infectious morbidity

    Time frame: 28 days after birth

    Sepsis, Suspected sepsis and Pneumonia

  8. Seizures / encephalopathy

    Time frame: 28 days after birth

    Witnessed seizure

  9. Hospital day of NICU admission

    Time frame: 28 days after birth

    Includes need for NICU or intermediate care admission and length of stay if admitted

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effects of Antenatal Corticosteroid in Twin Neonates With Late Preterm Birth: Study Protocol for a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Jun 6, 2018
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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