Lactoferrin or Progesterone for Prevention of Preterm Delivery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,030
- 试验地点
- 1
- 主要终点
- delayed days of birth using lattoferrin or progesterone
研究概览
简要总结
Primary endpoint will be evaluate the effectiveness of vaginal lactoferrin in the reduction of the 30% of preterm deliveries versus the use of progesterone, in specific selected patients, with consequent improvement in neonatal outcome.
Secondary endpoint will be compare antibacterial and anti-inflammatory activity of lactoferrin by evaluation of systemic biochemical and urinary markers.
详细描述
AIM OF THE STUDY Primary endpoint will be evaluate the effectiveness of vaginal lactoferrin in the reduction of the 30% of preterm deliveries versus the use of progesterone, in specific selected patients, with consequent improvement in neonatal outcome.
Secondary endpoint will be compare antibacterial and anti-inflammatory activity of lactoferrin by evaluation of systemic biochemical and urinary markers.
MATHERIAL AND METHODS Type of study: This is a randomized and open-label study (lactoferrin vs progesterone), multicenter.
Population of study: pregnant women 18-43 years aged with singleton pregnancy, between 24 and 34 weeks' gestation, who were at risk of preterm delivery.
Investigational products:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Cervical length less than 25 mm between 24 and 34 weeks' gestation (with or without funnelling)
- •cervical effacement less than 50 percent and cervical dilatation less than 3 cm
- •uterine contractions less than 4 in 30 minutes
- •singleton pregnancy
- •absence of chorioamnionitis signs (white cells count< 15.000, Reactive Protein C< 10 mg/l, Procalcitonin levels < 0,05 ng/ml),
- •absence of premature membrane rupture (pPROM).
排除标准
- •Fetal abnormalities such as severe intrauterine growth restriction and fetal malformations with progressive deterioration
- •Maternal diseases such as gestation diabetes insulin-treated, severe nephropaties, severe cardiopathies, autoimmune diseases
- •Twin pregnancy
- •Signs of maternal infections (chorioamnionitis)
- •Premature rupture of membrane
研究组 & 干预措施
Lattoferrin
Use of Lattoferin for prevention of preterm delivery
干预措施: Lattoferrin (Drug)
Progesterone
Use of Progesterone for prevention of preterm delivery
干预措施: Progesterone (Drug)
结局指标
主要结局
delayed days of birth using lattoferrin or progesterone
时间窗: days or weeks
次要结局
- neonatal outcome(28 days and 2 years follou-up)
研究者
Erich Cosmi MD, PhD
Associate Professor in Obstetrica and Gynecolgy
University of Padova