Back to resultsEffects of ACS in Twin With LPB: Study Protocol for a RCT
Primary Purpose
Twin Pregnancy, Antepartum Condition or Complication
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Betamethason Sodium Phosphate
Normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Twin Pregnancy, Antepartum Condition or Complication focused on measuring Antenatal corticosteroid, Twin pregnancies, Respiratory morbidity, Randomized controlled trial
Eligibility 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)
Sites / Locations
- Seoul National University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ACS (Group 1)
Placebo (Group 2)
Arm Description
Intramuscular injection of betamethason sodium phosphate 12mg (3ml) twice 24hours apart
Intramuscular injection of normal saline 3ml twice 24hours apart
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Maternal complication
Chorioamnionitis and Postpartum endometritis
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
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
Need for resuscitation at birth
any intervention in the first 30 minutes other than blow-by oxygen
Surfactant use
Surfactant use
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
Full Information
NCT ID
NCT03547791
First Posted
March 29, 2018
Last Updated
April 23, 2019
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03547791
Brief Title
Effects of ACS in Twin With LPB: Study Protocol for a RCT
Official Title
Effects of Antenatal Corticosteroid in Twin Neonates With Late Preterm Birth: Study Protocol for a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 5, 2018 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
4. Oversight
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
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Twin Pregnancy, Antepartum Condition or Complication
Keywords
Antenatal corticosteroid, Twin pregnancies, Respiratory morbidity, Randomized controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare 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.
Allocation
Randomized
Enrollment
808 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACS (Group 1)
Arm Type
Active Comparator
Arm Description
Intramuscular injection of betamethason sodium phosphate 12mg (3ml) twice 24hours apart
Arm Title
Placebo (Group 2)
Arm Type
Placebo Comparator
Arm Description
Intramuscular injection of normal saline 3ml twice 24hours apart
Intervention Type
Drug
Intervention Name(s)
Betamethason Sodium Phosphate
Other Intervention Name(s)
ACS
Intervention Description
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
Intervention Name(s)
Normal saline
Other Intervention Name(s)
NS
Intervention Description
Intramuscular injection of normal saline 3ml twice 24hours apart
Primary Outcome Measure Information:
Title
Incidence of respiratory morbidity
Description
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
Time Frame
72 hours after birth
Secondary Outcome Measure Information:
Title
Maternal complication
Description
Chorioamnionitis and Postpartum endometritis
Time Frame
72 hours after birth
Title
Respiratory distress syndrome
Description
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
Time Frame
72 hours after birth
Title
Transient tachypnea of the newborn, apnea
Description
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
Time Frame
72 hours after birth
Title
Need for resuscitation at birth
Description
any intervention in the first 30 minutes other than blow-by oxygen
Time Frame
at birth
Title
Surfactant use
Description
Surfactant use
Time Frame
28 days after birth
Title
Bronchopulmonary dysplasia;BPD
Description
Requirement for supplemental oxygen with a fraction of inspired oxygen of more than 0.21 for the first 28 days of life
Time Frame
28 days after birth
Other Pre-specified Outcome Measures:
Title
Necrotizing enterocolitis (NEC)
Description
meconium plug syndrome or confirmed NEC by pathohistology or operation finding
Time Frame
28 days after birth
Title
Birth weight
Description
neonatal body weight
Time Frame
at birth
Title
1 minute, 5minute Apgar score
Description
evaluation(scoring) of neonatal appearance, pulse, grimace, activity, respiration 1 minute and 5minute after birth
Time Frame
at birth
Title
Hypoglycemia
Description
Glucose < 40 mg%
Time Frame
28 days after birth
Title
Hyperbilirubinemia
Description
Peak total bilirubin of at least 15 mg% or the use of phototherapy
Time Frame
28 days after birth
Title
Feeding difficulty
Description
Inability to take all feeds (po), i.e. requiring gavage feeds or IV supplementation. In addition, time to first feed (po) will be recorded
Time Frame
28 days after birth
Title
Neonatal infectious morbidity
Description
Sepsis, Suspected sepsis and Pneumonia
Time Frame
28 days after birth
Title
Seizures / encephalopathy
Description
Witnessed seizure
Time Frame
28 days after birth
Title
Hospital day of NICU admission
Description
Includes need for NICU or intermediate care admission and length of stay if admitted
Time Frame
28 days after birth
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Mi Lee
Phone
+82-2-2072-4857
Email
smleemd@hanmail.net
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33368142
Citation
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.
Results Reference
derived
PubMed Identifier
30943910
Citation
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.
Results Reference
derived
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Effects of ACS in Twin With LPB: Study Protocol for a RCT
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