Antenatal Corticosteroids in TWIN late preterm neonates [ACTWIN] trial

Not Applicable

Recruiting

• Conditions: Pregnancy, childbirth and the puerperium

• Registration Number: KCT0004327
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 5 November 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 808

Inclusion Criteria

1) Twin pregnancy
2) Age?>?20?years
3) Women with twin pregnancy at 34?weeks 0?days to 36?weeks 5?days of gestation
4) At risk for preterm birth
- preterm labor
- PPROM (preterm premature rupture of membranes)
** threatened preterm labor: regular uterine contraction with or without following symptoms
- pelvic pressure, backache, increased vaginal discharge, menstrual-like cramps, bleeding/show, cervical chages

Exclusion Criteria

1) Gestational age before 34?weeks 0?days or after 36?weeks 6?days
2) Lethal major fotal anomaly, fetal distress or fetal death in utero, placenta abruption
3) Expected to deliver within 12?h
- Advanced cervical dilatation (=8?cm) in preterm labour
- Active phase labour (cervical dilatation =4?cm) in PPROM
4) History of a previous administration of antenatal corticosteroid within 1?week
5) Administration of systemic steroid for medical indications
6) Diagnosis of clinical chorioamnionitis : fever >37.8? and satisfy two of the followings
- uterine tenderness
- foul-odored vaginal discharge
- maternal leukocytosis (>15,000)
- maternal tachycardia (>100)
- fetal tachycardia (>160)
7) Contraindication of betamethasone administration
- patients with hypersensitivity
- infectious disease or systemic fungal infection patient without effective antibacterial/antifungal agent
- patients with infections within the joint cavity, intramucosa, and tendon
- patients with unstable joints (deterioration of joint symptoms)
- patients with herpes simplex, herpes zoster, chickenpox
- live vaccine administration patients

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Severe respiratory morbidities

Secondary Outcome Measures

Name	Time	Method
Mild respiratory morbidities;other neonatal morbidities