跳至主要内容
临床试验/CTRI/2024/09/073762
CTRI/2024/09/073762尚未招募不适用

Role of inflammatory markers (serum ferritin, C-reactive protein, interleukin 6) in recurrent pregnancy loss

未提供1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月21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
Association of inflammatory markers with recurrent pregnancy loss

研究概览

简要总结

This is a case-control study and will be conducted on patients attending the antenatal OPD/IPD/casualty at Lok Nayak Hospital for a period of one year.

A total number of 100 patients will be recruited in the study. Out of which 50 patients will be cases (with history of two pregnancy losses), 50 women with normal pregnancy and no history of miscarriages with matched period of gestation & BMI will be taken as controls.

A written informed consent to participate in the study will be taken from both cases and controls.

A predesigned structured proforma will be used to record the information about patient’s demography, socioeconomic status and complete obstetric history including previous antenatal records if present.

All the patients will undergo clinical examination and routine laboratory tests.

3 ml of venous blood sample will be taken in plain vial from both study and control groups to assess the levels of serum ferritin, CRP and IL6 levels. Patients will be managed as per the hospital protocols.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
Female

入选标准

  • FOR CASES: Pregnant women with two consecutive miscarriages.
  • FOR CONTROLS: Pregnant women without history of any miscarriage and with period of gestation and body mass index matched to that of study group.

排除标准

  • Pregnant woman with- 1.Known uterine anomalies 2.Chronic inflammatory diseases 3.Any acute illness in last 3 months HIV, Hepatitis B, Hepatitis C, VDRL infections 4.Any intramuscular injection in last 3 weeks 5.Steroids or immunomodulator therapy 6.Moderate to severe anemia 7.Diabetes and thyroid dysfunction 8.Diagnosed autoimmune disorders 9.Toxoplasmosis 10.Diagnosed fetal anomalies.

结局指标

主要结局

Association of inflammatory markers with recurrent pregnancy loss

时间窗: 1yr

次要结局

  • Difference in the level of inflammatory markers between women with recurrent pregnancy loss & normal pregnant women

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Shami Aara

Maulana Azad Medical College

研究点 (1)

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