Prospective Randomized Controlled Trial to Evaluate if Tailored Antibiotic and Steroid Therapy Based on the Interleukin-6 (IL-6) Value in Amniotic Fluid Obtained by Amniocentesis in Patients With Premature Rupture of Membranes is Associated With Pregnancy Prolongation Compared to Standard Management.
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
- 5
- 主要终点
- 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 goal of this clinical trial is to learn whether tailoring antibiotic and steroid treatment based on a lab result (interleukin-6, or IL-6) from amniotic fluid can help safely prolong pregnancy in people with preterm premature rupture of membranes (pPROM). This condition means the water breaks too early, before 37 weeks of pregnancy, which increases the risk of infection and early birth.
The main questions the study aims to answer are:
- Can using IL-6 levels to guide treatment help the pregnancy last more than 7 days after pPROM?
- Can this approach improve health outcomes for both the parent and the baby?
Researchers will compare two groups:
- A tailored treatment group, where IL-6 levels from amniotic fluid help decide when to give steroids and antibiotics.
- A standard care group, where everyone receives the same treatment right after diagnosis.
Participants will:
- Be screened to confirm pPROM and eligibility.
- Be randomly assigned to one of the two groups.
- Receive regular check-ups and monitoring in the hospital until delivery.
- In the tailored group, have weekly amniocentesis (a safe procedure to collect amniotic fluid) if needed.
The study includes follow-up for 6 months after birth to track both the baby's and parent's health.
This research may help doctors better time treatments, reduce unnecessary use of medications, and improve outcomes for families facing pPROM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pPPROM Confirmed by Amnisure test1 and/or clinical signs of pPROM on examination (Clinical signs of pPROM: presence of visual pooling of amniotic fluid during sterile speculum examination)
- •Weeks of pregnancy 22+03 - 33+64
- •Singleton pregnancy
- •Signed informed consent form (ICF)
- •Completely uncomplicated pregnancy until the occurrence of pPROM
排除标准
- •active labour (uterine activity leading to cervical dilatation greater than 4 cm)
- •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
- •Any contraindication according to the valid SmPC for the administered product
研究组 & 干预措施
ARM A: TAilored management
No steroids at admission Antibiotics - GBS prophylaxis + macrolides always at admission till results of amniotic fluid IL-6 Amniocentesis (Within 24 hours of admission to the hospital)
- Based on the amniotic fluid IL-6 results:
- IL-6 ˂ 2600 - discontinuing GBS prophylaxis + macrolides, no steroids.
- IL-6 ≥ 2600 - Steroids and initial broad spectrum ABX, adjustment according to cultures and PCR
干预措施: antibiotic prophylaxis (Drug)
ARM A: TAilored management
No steroids at admission Antibiotics - GBS prophylaxis + macrolides always at admission till results of amniotic fluid IL-6 Amniocentesis (Within 24 hours of admission to the hospital)
- Based on the amniotic fluid IL-6 results:
- IL-6 ˂ 2600 - discontinuing GBS prophylaxis + macrolides, no steroids.
- IL-6 ≥ 2600 - Steroids and initial broad spectrum ABX, adjustment according to cultures and PCR
干预措施: Antenatal steroids administration (Drug)
ARM A: TAilored management
No steroids at admission Antibiotics - GBS prophylaxis + macrolides always at admission till results of amniotic fluid IL-6 Amniocentesis (Within 24 hours of admission to the hospital)
- Based on the amniotic fluid IL-6 results:
- IL-6 ˂ 2600 - discontinuing GBS prophylaxis + macrolides, no steroids.
- IL-6 ≥ 2600 - Steroids and initial broad spectrum ABX, adjustment according to cultures and PCR
干预措施: Tailored antibiotic and steroid therapy based on the IL-6 value in amniotic fluid obtained by amniocentesis in patients with premature rupture of membranes (Procedure)
ARM A: TAilored management
No steroids at admission Antibiotics - GBS prophylaxis + macrolides always at admission till results of amniotic fluid IL-6 Amniocentesis (Within 24 hours of admission to the hospital)
- Based on the amniotic fluid IL-6 results:
- IL-6 ˂ 2600 - discontinuing GBS prophylaxis + macrolides, no steroids.
- IL-6 ≥ 2600 - Steroids and initial broad spectrum ABX, adjustment according to cultures and PCR
干预措施: Neuroprotection (Drug)
ARM B: standard care
Antenatal steroids - always at admission Antibiotics - GBS prophylaxis + macrolides, lasting for 7-10days, then discontinued.
干预措施: Antenatal steroids administration (Drug)
ARM B: standard care
Antenatal steroids - always at admission Antibiotics - GBS prophylaxis + macrolides, lasting for 7-10days, then discontinued.
干预措施: Neuroprotection (Drug)
ARM B: standard care
Antenatal steroids - always at admission Antibiotics - GBS prophylaxis + macrolides, lasting for 7-10days, then discontinued.
干预措施: antibiotic prophylaxis (Drug)
ARM B: standard care
Antenatal steroids - always at admission Antibiotics - GBS prophylaxis + macrolides, lasting for 7-10days, then discontinued.
干预措施: Antibiotics administration (Drug)
结局指标
主要结局
The latency of pregnancy of more than 7 days from premature rupture of membranes to delivery
时间窗: From enrollment to the delivery (0-98 days).
Latency ˃ 7d is an outcome traditionally used in trials studying pPROM and PTB.
The latency of pregnancy of more than 7 days from premature rupture of membranes to delivery
时间窗: From enrollment to the delivery (0-98 days).
Latency ˃ 7d is an outcome traditionally used in trials studying pPROM and PTB.
次要结局
- Latency to birth(Measured in days from pPROM to birth (0-98 days).)
- Incidence of chorioamnionitis and funisitis(From the enrollment to the delivery (0-98 days).)
- Short-term adverse maternal outcomes(From the enrollment to the 6 weeks postpartum. Time from enrollment to delivery is 0-14 weeks. Time frame ranges from 0-20 weeks.)
- Short-term neonatal outcomes(From the birth to 6-months postpartum.)
- Latency to birth(Measured in days from pPROM to birth (0-98 days).)
- Incidence of chorioamnionitis and funisitis(From the enrollment to the delivery (0-98 days).)
- Short-term adverse maternal outcomes(From the enrollment to the 6 weeks postpartum. Time from enrollment to delivery is 0-14 weeks. Time frame ranges from 0-20 weeks.)
- Short-term neonatal outcomes(From the birth to 6-months postpartum.)
研究者
David Cibula
Prof. Dr.
General University Hospital, Prague