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临床试验/NCT05986357
NCT05986357尚未招募不适用

The Relation Between Maternal Serum High Sensitivity C Reactive Protein and Total and Differential Leucocytic Count Levels in Healthy Pregnant Women With Threatened Abortion and the Outcome of Pregnancy

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2023年7月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
240
试验地点
1
主要终点
Highly sensitive CRP (HS-CRP)

研究概览

简要总结

to identify the relation between maternal serum high sensitivity C reactive protein and total and differential leucocytic count values in healthy pregnant women with threatened abortion and the outcome of pregnancy

详细描述

observational prospective cohort research will be pregnant women attending to obstetrics and gynecology department of University Hospital. After enrollment, participants will be divided into two groups:

  • Study group: had 120 healthy women presenting with threatened miscarriage.
  • Control group: had 120 healthy women with an uncomplicated single pregnancy. informed permission will be obtained. All cases subjected to the following: taking complete history, General examination, Special investigations including Obstetric ultrasonography for assessment of gestational age, and exclusion of congenital anomalies or multi-fetal gestation. Laboratory investigations including Estimation of the complete blood picture (CBC), Highly sensitive CRP (HS-CRP) single measurement, Women over 1st trimester abdominal ultrasonographic examination (6-13weeks) using Toshiba with transabdominal transducer probe frequency of 7 MHz to evaluate the following data: Measuring of the fetal crown-rump length (CRL) done to confirm the fetal gestational age and the viability of the fetus. Gestational age will be calculated from the beginning of the last regular menstrual cycle. Women who had hormone therapy or progesterone supplements, as well as pregnancies with a discrepancy between LMP and crown rump length of more than three days, were excluded from the research.

Pregnant women will be under close follow up every 2 weeks by: Obstetric U/S, Measure blood pressure and inform us if severe bleeding occurs.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Single intrauterine pregnancy with vaginal hemorrhage and/or abdominal pain in the study group,
  • an ultrasound showing an intrauterine gestational sac with a live fetus and a regular fetal heartbeat, with/without a sub-chorionic hematoma,
  • healthy women who come for routine antenatal care with spontaneous pregnancy.

排除标准

  • Age over 40
  • multiple pregnancies
  • endocrinological diseases
  • history of repeated spontaneous abortions.

结局指标

主要结局

Highly sensitive CRP (HS-CRP)

时间窗: 9 months

A high level of hs-CRP, i.e., greater than 3 mg/L,

total leucocytic count

时间窗: 9 months

measures the number of white blood cells (WBCs) in blood

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Abdallah Mohamed Salem

principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Beni-Suef University

研究点 (1)

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