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临床试验/CTRI/2025/04/083851
CTRI/2025/04/083851已完成不适用

A Prospective cohort study of Iron profile values estimated during early pregnancy and their correlation with the onset of hypertensive disorders of pregnancy

Shri B M Patil Medical College Hospital and Research centre1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年4月12日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
1.To associate iron profile levels estimated during early

研究概览

简要总结

Preeclampsia is characterized by the onset of hypertension and proteinuria or other signs of end-organ dysfunction after 20 weeks of gestation in a previously normotensive patient. Its pathophysiology involves abnormal placentation, an imbalance of prostaglandins, inflammatory mediators, oxidative stress, and an imbalance of angiogenic and anti-angiogenic proteins.

Hypertension and anemia are the common medical complications of pregnancy that contribute  to maternal and perinatal mortality. So, identifying this condition as early as possible will bring a better outcome for pregnancy. Preeclampsia is defined as the new onset of hypertension and either proteinuria or other signs of end-organ dysfunction after 20 weeks of gestation in a previously normotensive patient.

The pathophysiology of preeclampsia is due to abnormal placentation, imbalance in different components of prostaglandins, inflammatory mediators, oxidative stress and  imbalance of angiogenic and anti-angiogenic proteins.

Iron is an important element that causes oxidative stress and damage to endothelial cells. The need of iron, increases during pregnancy, deficiency (levels below 9.5- 10.5gm/dl ) of   which leads to development of anemia and adverse maternal and fetal outcomes. And at the same time high serum iron levels are associated with preeclampsia. Serum ferritin is glycoprotein which is a primary form of iron storage and is the most effective indicator of iron status, in the absence of any infection or  inflammation. Studies done by

Zhuanji Fang et al,which is the only study available estimating serum ferritin levels during early pregnancy has found that the risk of pregnancy related hypertensive   disorders increase with increase in early pregnancy serum ferritin levels.

Total iron binding capacity increases and transferrin saturation decreases with decrease in serum iron levels and thus is useful marker for detecting iron deficiency anemia.

Presently only one prospective study done by MaÅ‚gorzata Lewandowska et al, is available in which it was concluded that low serum iron levels  estimated during early   pregnancy were associated with preeclampsia.

Since the results were contradictory we would like to do a prospective study measuring the complete iron profile levels between 12-20 weeks of gestation to see what parameters correlates with development of preeclampsia.These parameters can also further be used as a biochemical predictor of preeclampsia and guide us regarding, whether  routine prophylactic supplementation of iron is to be done or not.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 30.00 Year(s)(—)
性别
Female

入选标准

  • All singleton pregnant women within 18-30 age group with periods of gestation equal to or more than 12 weeks and less than or equal to 19 weeks and six days.

排除标准

  • 1.Chronic hypertensive patients 2.Known case of chronic infections.
  • 3.Known case of malignancies.
  • 4.Known case of Liver, Renal or cardiac disease.
  • 5.Known case of hemochromatosis.
  • 6.H/O past blood transfusions or parenteral iron infusions in the last 3 months.
  • 7.Known case of hemoglobinopathies.
  • Pregnancy with anomalous babies.
  • 8.H/O anemia with Hb less than 11g/dl.

结局指标

主要结局

1.To associate iron profile levels estimated during early

时间窗: 1.The women taken into the study are followed from 12 weeks to the time of delivery to look for any hypertensive disorders of pregnancy

pregnancy with the onset of hypertensive disorders of pregnancy.

时间窗: 1.The women taken into the study are followed from 12 weeks to the time of delivery to look for any hypertensive disorders of pregnancy

2.Gestational age at the time of development of hypertensive disorders of pregnancy.

时间窗: 1.The women taken into the study are followed from 12 weeks to the time of delivery to look for any hypertensive disorders of pregnancy

pregnancy

时间窗: 1.The women taken into the study are followed from 12 weeks to the time of delivery to look for any hypertensive disorders of pregnancy

次要结局

  • Maternal outcome:(a] Gestational age at delivery)

研究者

发起方
Shri B M Patil Medical College Hospital and Research centre
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

SREE KAVYA MEDA

SHRI B M PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE

研究点 (1)

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