LOW DOSE ASPIRIN FOR THE PREVENTION OF SPONTANEOUS PRETERM LABOUR IN WOMEN AT RISK FOR PRETERM BIRTH

PGIMER1 个研究点分布在 1 个国家目标入组 100 人开始时间: 2021年8月3日最近更新: 2021年10月21日

试验速览

阶段: 不适用
状态: 招募中
发起方: PGIMER
入组人数: 100
试验地点: 1
主要终点: To compare incidence of preterm birth at less than 37 weeks of gestation between aspirin and non aspirin groups

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Aspirin is a commonly prescribed drug in antenatal women at risk for preeclampsia.Secondary outcomes of studies have shown that aspirin given to women also lowered the incidence of preterm birth apart from having a protective role in preeclampsia.This study aims to see the effect of aspirin in reducing incidence of preterm birth in women at risk.Aspirin is a cheap intervention and could prove useful in low resource settings if found effective.

研究设计

研究类型: Interventional
分配方式: Random Number Table
盲法: Open Label

入排标准

年龄范围: 18.00 Year(s) 至 40.00 Year(s)（—）
性别: Female

入选标准

•Antenatal Women between 6 to 16 weeks of gestation Singleton Pregnancy History of previous spontaneous preterm birth and/or PPROM or history of second trimester abortion.

排除标准

•Previous indicated preterm birth for maternal or fetal reasons Contraindications to aspirin use Major fetal malformations in current or previous pregnancy Multifetal gestation Moderate /severe anaemia Medical comorbidities Uterine anomalies and cervical insufficiency At risk for preeclampsia.

结局指标

主要结局

To compare incidence of preterm birth at less than 37 weeks of gestation between aspirin and non aspirin groups

时间窗: 9 months

次要结局

To compare maternal complications and neonatal outcomes between aspirin and non aspirin groups(9 months)

研究者

发起方

PGIMER

申办方类型

Research institution

研究点 (1)

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