Effects of ACS in Twin With LPB: Study Protocol for a RCT (NCT03547791) | Clinical Trial Compass
CompletedPhase 2/3
Effects of ACS in Twin With LPB: Study Protocol for a RCT
South Korea848 participantsStarted 2018-05-05
Plain-language summary
This study will be the first study that evaluates the effectiveness of antenatal corticosteroid (ACS) in late preterm twin neonates.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)