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临床试验/NCT02420769
NCT02420769已完成不适用

Color Doppler of CL and Uterine Artery With Serum Progesterone and CA125 in Threatened Abortion

Nesreen Abdel Fattah Abdullah Shehata1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年9月最近更新:
适应症

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
Viable fetus (According to WHO viable fetus >500 gm or > 20 weeks)

研究概览

简要总结

The purpose of this study is to determine whether assessing color doppler of corpus luteum and uterine artery is useful in predicting patients who will complete pregnancy. The investigators will add to this the usefulness of serum progesterone and CA125 in prediction.

详细描述

The introduction of Doppler ultrasound in obstetrics has allowed evaluating hemodynamic characteristics from the first trimester of pregnancy. For example, Kurjak et al.,in one of the first studies using transvaginal pulsed-wave Doppler ultrasound in early pregnancies, identified the uterine arteries in 100% of the patients. The flow blood of the corpus luteum was identified in 75% patients. The measures obtained by Doppler ultrasonography that may have prognostic value to the evolution of pregnancy include uteroplacental blood flow, also known as trophoblastic flow. Jaffe et al. reported that abnormal Doppler findings were associated with a significantly higher prevalence of complicated pregnancies, among women with abnormal Doppler findings, 43% ended in miscarriage, whereas among women with normal findings only 1.4% of women miscarried.Progesterone plays a crucial role in the maintenance of pregnancy. In the presence of sufficient progesterone levels during pregnancy, lymphocytes synthesize a mediator called progesterone induced blocking factor (PIBF), which is anti-abortive in mice . Besides inducing secretary changes in the endometrium and supporting early pregnancy, it modulates the maternal immune response to prevent fetal rejection and relaxes the uterine smooth muscles .CA-125, well-known as a tumor marker for epithelial ovarian cancer , is a high molecular weight glycoprotein that is produced not only by ovarian cancer, but also by nonovarian tumors, normal epithelia of the peritoneum, the endometrium, the fallopian tube, and the ovary. Because CA-125 is also produced by the endometrium, some authors suggest that CA-125 can be used as a marker for endometrial receptivity in patients undergoing IVF . Its role as a predictor for pregnancy outcome is controversial .

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • patients with pregnancy between 8 to 20 weeks of gestation,
  • who were diagnosed with threatened abortion.

排除标准

  • patients with multiple pregnancies,
  • molar pregnancy,
  • ectopic pregnancy,
  • amenorrhea with different etiologies of pregnancy,
  • maternal history of systemic diseases and uterine anatomic abnormalities
  • patients who did not have their outcome data through week 20 of gestation due to relocation.

结局指标

主要结局

Viable fetus (According to WHO viable fetus >500 gm or > 20 weeks)

时间窗: from 20 weeks till 21 weeks gestation

The investigators will assess how many patients in both groups reached viability of fetus. According to WHO viable fetus \>500 gm or \> 20 weeks.

次要结局

  • Resistance index of uterine artery and corpus luteum(from 8 weeks till 20 weeks)
  • serum CA125 and progesterone(from 8 weeks till 20 weeks gestation)

研究者

发起方
Nesreen Abdel Fattah Abdullah Shehata
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nesreen Abdel Fattah Abdullah Shehata

Assisstant professor of Obstetrics and Gynecology

Beni-Suef University

研究点 (1)

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