Twin Pregnancy, Antepartum Condition or Complication
Conditions
Keywords
Antenatal corticosteroid, Twin pregnancies, Respiratory morbidity, Randomized controlled trial
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.
Interventions
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.
DRUGNormal saline
Intramuscular injection of normal saline 3ml twice 24hours apart
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
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.
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of respiratory morbidity | 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
| Measure | Time frame | Description |
|---|---|---|
| Respiratory distress syndrome | 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 |
| Transient tachypnea of the newborn, apnea | 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 |
| Maternal complication | 72 hours after birth | Chorioamnionitis and Postpartum endometritis |
| Surfactant use | 28 days after birth | Surfactant use |
| Bronchopulmonary dysplasia;BPD | 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 |
| Need for resuscitation at birth | at birth | any intervention in the first 30 minutes other than blow-by oxygen |
Other
| Measure | Time frame | Description |
|---|---|---|
| Seizures / encephalopathy | 28 days after birth | Witnessed seizure |
| Hyperbilirubinemia | 28 days after birth | Peak total bilirubin of at least 15 mg% or the use of phototherapy |
| Hospital day of NICU admission | 28 days after birth | Includes need for NICU or intermediate care admission and length of stay if admitted |
| Necrotizing enterocolitis (NEC) | 28 days after birth | meconium plug syndrome or confirmed NEC by pathohistology or operation finding |
| Birth weight | at birth | neonatal body weight |
| 1 minute, 5minute Apgar score | at birth | evaluation(scoring) of neonatal appearance, pulse, grimace, activity, respiration 1 minute and 5minute after birth |
| Hypoglycemia | 28 days after birth | Glucose \< 40 mg% |
| Feeding difficulty | 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 |
| Neonatal infectious morbidity | 28 days after birth | Sepsis, Suspected sepsis and Pneumonia |
Countries
South Korea
Outcome results
None listed