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临床试验/NCT06011057
NCT06011057已完成不适用

Evaluation of Serum Levels of C Reactive Protein (CRP) and Its Correlation With Fetal Ultrasound Parameters in the Prediction of Threatened Miscarriage in the First Trimester

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Serum C reactive protein (CRP) levels in threatened miscarriage vs control groups

研究概览

简要总结

The goal of this observational study is to evaluate and compare in pregnant women with threatened miscarriage in the first trimester. The main questions it aims to answer are:

What is the correlation between serum C reactive protein (CRP) levels and fetal ultrasound parameters in predicting threatened miscarriage? How accurate are serum C reactive protein (CRP) levels versus ultrasound in predicting pregnancy loss in threatened miscarriage? Participants will have blood tests to measure C reactive protein (CRP) levels and fetal ultrasound exams to assess parameters like crown-rump length.

Researchers will compare serum C reactive protein (CRP) levels and fetal ultrasound findings to see if either or both can accurately predict pregnancy loss in women with first trimester threatened miscarriage.

详细描述

This observational study will enroll 100 pregnant women, with 50 in the threatened miscarriage group and 50 healthy controls, to compare serum C reactive protein (CRP) levels and fetal ultrasound findings for predicting early pregnancy loss.

Women presenting with first trimester bleeding and cramps concerning for threatened miscarriage will undergo blood testing to measure C reactive protein (CRP) levels and fetal ultrasound to assess parameters including crown-rump length, heartbeat, yolk sac size, and embryonic motion.

The control group will consist of 50 low-risk pregnant women without threatened miscarriage matched for gestational age. Controls will undergo the same blood and ultrasound assessments.

Researchers will compare serum C reactive protein (CRP) levels and ultrasound measurements between the threatened miscarriage and control groups. They will analyze which parameters differ significantly between groups and examine the predictive utility of C reactive protein (CRP) levels versus ultrasound for determining pregnancy viability.

Key outcomes will include correlation of C reactive protein (CRP) with ultrasound parameters, and diagnostic accuracy of C reactive protein (CRP) levels versus ultrasound in predicting pregnancy loss in threatened first trimester miscarriages.

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
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • All pregnant women in the age group (20-35) between 7 and 13 weeks gestation in which a singleton embryo with evident cardiac activity with sure last menstrual period (LMP) constant with 1st trimester documented ultrasound
  • The included subjects will be divided into two groups:-
  • Group 1 (control) will consist of 50 pregnant women with uneventful pregnancies without any problem.
  • Group 2 (patients) will consist of 50 pregnant women with threatened miscarriage, of them.

排除标准

  • Multiple pregnancies.
  • Women having received hormonal treatment or progesterone supplements.
  • Pregnancies with a difference of more than 7 days between last menstrual period (LMP) and crown- rump length.
  • History of general medical disease e.g. diabetes, thyroid disease or antiphospholipid syndrome, Presence of local (gynecological) disease e.g. fibroid or adnexal masses verified by normal appearance of the uterus and ovaries by ultrasound.
  • Presence of uterine malformations e.g. hypoplastic uterus or septate uterus diagnosed by history of recurrent miscarriage, hysterosalpingography or 3D ultrasound, Intake of natural or synthetic progesterone.
  • Ectopic pregnancy
  • Vesicular mole
  • Fetal demise by Ultrasound

结局指标

主要结局

Serum C reactive protein (CRP) levels in threatened miscarriage vs control groups

时间窗: At enrollment (6-14 weeks gestation)

Serum C-reactive protein (CRP) levels will be compared between the threatened miscarriage and control groups. CRP levels will be assessed from blood samples collected at the time of enrollment in the study (6-14 weeks gestation). The goal is to determine if CRP levels differ significantly between the threatened miscarriage and control groups and examine the correlation between C reactive protein (CRP) levels and threatened early pregnancy loss.

次要结局

  • Ongoing pregnancy(Ongoing pregnancy assessed at 24 weeks gestation)
  • miscarriage rates(pregnancy loss before 20 weeks)

研究者

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

Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy

lecturer and consultant at Obstetrics and Gynecology Department.

Al-Azhar University

研究点 (1)

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