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

Twin Pregnancy, Antepartum Condition or Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03547791
• Other study ID #: Twin_RCT_2018
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: May 5, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 808
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Obstetric Labor Complications
• Twin Pregnancy, Antepartum Condition or Complication

Intervention

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.
• Normal saline
Intramuscular injection of normal saline 3ml twice 24hours apart

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Necrotizing enterocolitis (NEC)	meconium plug syndrome or confirmed NEC by pathohistology or operation finding	28 days after birth
Other	Birth weight	neonatal body weight	at birth
Other	1 minute, 5minute Apgar score	evaluation(scoring) of neonatal appearance, pulse, grimace, activity, respiration 1 minute and 5minute after birth	at birth
Other	Hypoglycemia	Glucose < 40 mg%	28 days after birth
Other	Hyperbilirubinemia	Peak total bilirubin of at least 15 mg% or the use of phototherapy	28 days after birth
Other	Feeding difficulty	Inability to take all feeds (po), i.e. requiring gavage feeds or IV supplementation. In addition, time to first feed (po) will be recorded	28 days after birth
Other	Neonatal infectious morbidity	Sepsis, Suspected sepsis and Pneumonia	28 days after birth
Other	Seizures / encephalopathy	Witnessed seizure	28 days after birth
Other	Hospital day of NICU admission	Includes need for NICU or intermediate care admission and length of stay if admitted	28 days after birth
Primary	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	72 hours after birth
Secondary	Maternal complication	Chorioamnionitis and Postpartum endometritis	72 hours after birth
Secondary	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	72 hours after birth
Secondary	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	72 hours after birth
Secondary	Need for resuscitation at birth	any intervention in the first 30 minutes other than blow-by oxygen	at birth
Secondary	Surfactant use	Surfactant use	28 days after birth
Secondary	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	28 days after birth