CTRI/2021/03/032429招募中3 期
WHO ACTION-III: A multi-country, multi-centre, three-arm, parallel group, double-blind, placebo-controlled, randomized trial of two doses of antenatal corticosteroids for women with a high probability of birth in the late preterm period in hospitals in low-resource countries to improve newborn outcomes - WHO ACTION-III
试验速览
- 阶段
- 3 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •The population of interest is women with singleton or multiple pregnancy at 34 weeks to 36 weeks and 5 days and a high probability of late preterm birth (which extends up to 36 weeks 6 days).
- •1. Gestational age from 34 weeks 0 days to 36 weeks 5 days
- •2. High probability of late preterm birth (up to 36+6 weeks) defined as birth expected between 12 hours and 7 days after randomization as a result of:
- •A. Membrane rupture without preterm labour (where preterm labour is defined as at least 6 regular uterine contractions/ hr and any one of the following: cervical dilatation of more than or equal to 3 cm or effacement more than or equal to 75%). OR
- •B. Preterm labour with intact membranes, defined as at least 6 regular contractions/hr and one of the following: (i) cervix more than or equal to 3cm dilated or (ii) 75% effaced; OR
- •C . Planned delivery by induction of labour or caesarean section between 24hours and 7 days, as deemed necessary by the provider. An induction must be scheduled to start by 36+5 weeks at the latest, whereas a caesarean delivery must be scheduled by 36+6 weeks at the latest
- •3. Singleton or multiple pregnancies, where the foetus/es (or at least one foetus in a multiple pregnancy) is/are confirmed alive by doppler or USG
- •4. Women with no clinical signs of severe infection (as per obstetric care physician’s assessment)
- •5. Women willing and able to provide consent (or if a minor, provides assent and guardian provides consent)
- •Women with the following conditions will be eligible. Any comorbid conditions will be managed according to local guidelines, and in line with WHO recommendations:
- •-Women with a history of previous preterm birth
- •-Women with hypertensive disorders
- •-Women with a growth impaired foetus
- •-Women with pre-gestational or gestational diabetes
- •-Women with HIV/AIDs
排除标准
- •1. Ruptured membranes with cervix dilated more than or equal to 3cm or effaced more than or equal to 75%, or with more than 6 contractions per hour (or both)
- •2. Cervical dilation of more than or equal to 8 cm with intact membranes
- •3. Clinical suspicion or evidence of clinical chorioamnionitis or severe infection, as per obstetric care physician assessment
- •4. Evidence of non-reassuring foetal status requiring immediate delivery
- •5. Major or lethal congenital foetal anomaly identified
- •6. No prior ultrasound-based estimate of gestational age available and immediate ultrasound examination is not possible
- •7. Any systemic corticosteroid use during the current pregnancy (outside of trial)
- •8. Unwilling or unable to provide consent or assent (including due to active labour)
- •9. Currently a participant in another clinical trial related to maternal and neonatal health, or previously participated in any ACTION trial
- •10. Any other clinical indication where the treating clinician considers corticosteroids to be contraindicated
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