Clinical trial NCT03547791: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Twin Pregnancy, Antepartum Condition or Complication
Keywords: Antenatal corticosteroid
Twin pregnancies
Respiratory morbidity
Randomized controlled trial
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 848
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Incidence of respiratory morbidity
timeFrame: 72 hours after birth
Secondary outcomes:
measure: Maternal complication
timeFrame: 72 hours after birth
measure: Respiratory distress syndrome
timeFrame: 72 hours after birth
measure: Transient tachypnea of the newborn, apnea
timeFrame: 72 hours after birth
measure: Need for resuscitation at birth
timeFrame: at birth
measure: Surfactant use
timeFrame: 28 days after birth
measure: Bronchopulmonary dysplasia;BPD
timeFrame: 28 days after birth
Other outcomes:
measure: Necrotizing enterocolitis (NEC)
timeFrame: 28 days after birth
measure: Birth weight
timeFrame: at birth
measure: 1 minute, 5minute Apgar score
timeFrame: at birth
measure: Hypoglycemia
timeFrame: 28 days after birth
measure: Hyperbilirubinemia
timeFrame: 28 days after birth
measure: Feeding difficulty
timeFrame: 28 days after birth
measure: Neonatal infectious morbidity
timeFrame: 28 days after birth
measure: Seizures / encephalopathy
timeFrame: 28 days after birth
measure: Hospital day of NICU admission
timeFrame: 28 days after birth
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
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.
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.