2024-520237-77-00招募中3 期
TAILORED-PROM: TAILORED therapeutic regime in patients with preterm Premature Rupture Of Membranes to prolong pregnancy, improve maternal and neonatal outcomes, and reduce antibiotic burden
Vseobecna Fakultni Nemocnice V Praze3 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2025年4月17日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 138
- 试验地点
- 3
- 主要终点
- The primary endpoint of the study is the latency of pregnancy of more than 7 days from premature rupture of membranes to delivery.
研究概览
简要总结
The objective of the trial is to evaluate if tailored antibiotic and steroid therapy based on the IL-6 value in amniotic fluid obtained by amniocentesis in patients with premature rupture of membranes is associated with pregnancy prolongation compared to standard treatment.
入排标准
- 年龄范围
- In utero 至 64 years（In utero, 18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •pPPROM Confirmed by Amnisure test and/or clinical signs of pPROM on examination
- •Weeks of pregnancy 22+0 – 33+6
- •Singleton pregnancy
- •Signed informed consent form (ICF)
- •Completely uncomplicated pregnancy util the occurrence of pPROM
排除标准
- •Active labour (uterine activity leading to cervical dilatation greater than 4 cm)
- •Any contraindication according to the valid SmPC for the administered product
- •Obstetrical reason for immediate delivery such as heavy vaginal bleeding, prolapsed cord, or foetal distress.
- •Multiple pregnancy
- •Pregnancy with chromosomal or severe morphological abnormality.
- •Signs of chorioamnionitis at the admission (clinical and/or laboratory).
- •Patients with severe immunological compromise (immunodeficient).
- •Patients with an oncological disease/immunosuppression.
- •Patients with an active drug abuse.
- •Non-compliant patients.
结局指标
主要结局
The primary endpoint of the study is the latency of pregnancy of more than 7 days from premature rupture of membranes to delivery.
The primary endpoint of the study is the latency of pregnancy of more than 7 days from premature rupture of membranes to delivery.
次要结局
- Latency to birth
- Incidence of chorioamnionitis and funisitis
- Short-term adverse maternal outcomes
- Short-term neonatal outcomes
- Microbiome in mother and newborn - optional outcome
研究者
Katerina Mackova
Scientific
Vseobecna Fakultni Nemocnice V Praze
研究点 (3)
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