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临床试验/CTRI/2024/08/072969
CTRI/2024/08/072969尚未招募2 期

Prophylactic antibiotic treatment duration in preterm premature rupture of membranes: 7 days versus until delivery

SHRI B M PATIL MEDICAL COLLEGE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年9月4日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
110
试验地点
1
主要终点
The duration of antibiotic theraphy Ceftrioxone and Clarithromycin until delivery in pprom shows reduced incidence of neonatal morbidity.

研究概览

简要总结

ï‚· One of the most common causes of preterm birth is Preterm Premature Rupture of membranes (PPROM). ï‚· The ideal approach to the clinical assessment and treatment of women with and preterm PROM remains debatable. ï‚· Management depends on gestational age and evaluation of the relative risks of delivery versus the risks of expectant management. ï‚· PPROM constitutes 2-3% of all complicated pregnancies and is one of the major causes of preterm deliveries and is associated with neonatal morbidity. ï‚· The key strategy to prolong the interval from rupture of membranes to the delivery in PPROM patients is antibiotic therapy. The treatment was proved to be effective in both prolongation of pregnancy and improvement of short-term neonatal outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • Gestational age of 26weeks+0 days to 36weeks+6days 2)PPROM within 72 hours with cervical dilatation less than 3cms 3)Singleton pregnancy 4)Foetal anomalies 5)Abnormal placentation 6)Maternal comorbidities 7)Recentaly documented infections of urogenital tract.

排除标准

  • fetal anomaly 2)abnormal placentation 3)maternal comorbiditis 4)h/o cervical incompitance 5)recent infections of urogenital tract.

结局指标

主要结局

The duration of antibiotic theraphy Ceftrioxone and Clarithromycin until delivery in pprom shows reduced incidence of neonatal morbidity.

时间窗: 7 days to until delivery

次要结局

  • The duration of antibiotic theraphy ceftrioxone & clarithromycin untill delivery in pprom shows reduced incidence of infantile neurological outcomes

研究者

发起方
SHRI B M PATIL MEDICAL COLLEGE AND HOSPITAL
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Guddad Shabana Hameed

SHRI BM PATIL MEDICAL COLLEGE AND HOSPITAL

研究点 (1)

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