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

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ClinicalTrials.gov Identifier: NCT03547791
Recruitment Status : Recruiting
First Posted : June 6, 2018
Last Update Posted : April 25, 2019
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Twin Pregnancy, Antepartum Condition or Complication Drug: Betamethason Sodium Phosphate Drug: Normal saline Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 808 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Care Provider)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Effects of Antenatal Corticosteroid in Twin Neonates With Late Preterm Birth: Study Protocol for a Randomized Controlled Trial
Actual Study Start Date : May 5, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Active Comparator: ACS (Group 1)
Intramuscular injection of betamethason sodium phosphate 12mg (3ml) twice 24hours apart
Drug: 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.
Other Name: ACS

Placebo Comparator: Placebo (Group 2)
Intramuscular injection of normal saline 3ml twice 24hours apart
Drug: Normal saline
Intramuscular injection of normal saline 3ml twice 24hours apart
Other Name: NS




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03547791


Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Seung Mi Lee    +82-2-2072-4857    smleemd@hanmail.net   
Sponsors and Collaborators
Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03547791     History of Changes
Other Study ID Numbers: Twin_RCT_2018
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: April 25, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Seoul National University Hospital:
Antenatal corticosteroid
Twin pregnancies
Respiratory morbidity
Randomized controlled trial

Additional relevant MeSH terms:
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Obstetric Labor Complications
Pregnancy Complications
Betamethasone sodium phosphate
Betamethasone
Betamethasone Valerate
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents
Anti-Asthmatic Agents
Respiratory System Agents