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临床试验/CTRI/2024/10/075782
CTRI/2024/10/075782尚未招募不适用

Prediction of spontaneous preterm birth in women by transvaginal sonographic measurement of cervical length between 18 to 24 weeks of gestation

Maulana Azad medical College1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月3日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
1) Mean cervical length between 18-24 weeks of gestation

研究概览

简要总结

AIM: To measure cervical length between 18-24 weeks of gestation by transvaginal ultrasonography for prediction of spontaneous preterm birth

Primary outcome:

  1. Mean cervical length between 18-24 weeks of gestation

  2. No. of women who deliver before 34 weeks of gestation

Secondary outcome:

  1. No. of women who delivers before 37 weeks of gestation

  2. Proportion of women with cervical length less than 25mm who delivers before 34 and 37 weeks of gestation

  3. Proportion of women with cervical length more than 25 mm who delivers before 37 and 37 weeks of gestation

Methodology:

100 Pregnant women seeking antenatal care between 18-24 weeks of gestation fulfilling inclusion and exclusion criteria will be recruited for the study. Cervical length measurement by transvaginal ultrasound will be done. All the women will be followed till delivery and the details of gestational age at delivery, mode of onset of labor, obstetrical outcome and neonatal outcome will be recorded

研究设计

研究类型
Interventional
分配方式
Na
盲法
Participant Blinded

入排标准

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

入选标准

  • Pregnant women within the age group of 18-35 years.
  • Single live intrauterine pregnancy with gestational age 18-24 weeks.
  • Confirmation of gestational age with at least one ultrasound performed at less than 16 weeks.

排除标准

  • Previous history of Preterm Delivery(less than 37 weeks) 2) Previous history of cervical Surgery 3) Any diagnosed uterine structural anomaly 4) Any fetal congenital malformation 5) Placenta previa in present pregnancy.

结局指标

主要结局

1) Mean cervical length between 18-24 weeks of gestation

时间窗: upto 22 weeks

2) No. of women who deliver before 34 weeks of gestation

时间窗: upto 22 weeks

次要结局

  • 1) No. of women who deliver before 37 weeks of gestation

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Kanishka Yadav

Maulana Azad medical college

研究点 (1)

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