Uterine Artery Doppler Flow Velocimetry Parameters for Predicting the Occurrence of Persistent Gestational Trophoblastic Neoplasia After Evacuation of Complete Hydatiform Mole ( a Prospective Cohort Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 175
- 主要终点
- Uterine artery Doppler flow velocimetry
研究概览
简要总结
This Prospective study will be conducted To copare uterine blood flow using Doppler ultrasound before and after evacuation of hydatiform mole between female patients with remissions and those with development of post-molar persistent gestational trophoblastic neoplasia to detect accuracy,efficacy,predictive value and acceptability of uterine artery doppler in predicting gestional trophoblastic neoplasia .
详细描述
Progression of complete hydatidiform mole to gestational trophoblastic neoplasia was reported to occur in 9 - 20% of patients. Suction curettage is considered the standard method of complete hydatiform mole evacuation .
Identification of occurrence of post-molar malignancy was detected during follow-up by serial assessment of serum human chorionic gonadotropin (hCG) . hCG rising or plateau mostly points to progression to malignancy thus requiring chemotherapy.Predicting liability to occurrence of post-molar malignancy mainly in patients with difficult continuous assessment of hCG is very important for adequate prompt management avoiding exposure to unnecessary chemotherapy .
There are many established predictive factors of post-molar malignancy as; patients age, size of ovaries, size of uterus, previous molar pregnancy, serial assessment of hCG level ,levels of vascular endothelial growth factor,TGF- beta 3 and HIF- 1alpha.
Moreover Trans-vaginal ultrasound with power Doppler might be used as a predictive factor for delayed response and resistance to chemotherapy particularly low-risk trophoblastic diseases .
Pelvic Doppler ultrasound is considered an essential diagnostic tool for evaluating uterine size and blood flow in patients with gestational trophoblastic neoplasia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed diagnosis of complete hydatiform mole.
- •Hemodynamically stable patient .
- •No contraindication for anesthetic materials used for the evacuation .
- •Acceptance of possible prolonged follow up , repeated uterine artery doppler ultrasound ,repeated HCG tests
排除标准
- •Patient refusal to participate in the study.
- •Patient with incomplete hydatiform mole .
- •Patients who were lost during the follow-up period after this procedure.
- •Contraindication for anesthetic materials used for the evacuation .
结局指标
主要结局
Uterine artery Doppler flow velocimetry
时间窗: We will perform DFV of uterine arteries on both sides at admission and 4 - 6 weeks after evacuation.
First the patient will evaluate the urinary bladder Positioning of patient:supine position Amidsagittal section of uterus and cervical canal is obtained and the transducer is moved laterally untill the paracervical vessels are visualized color flow doppler is applied the uterine arteriesare seen as aliasing vessels along the side of the cervix Uterine artery doppler indices will be measured PSV=peak systolic velocity EDV=end diastolic velocity TAMV=time average medium velocity P.I(pulsatile index)=PSV-EDV/TAMV R.I(resistance index)=(PSV-EDV)/PSV SD(systolic diastolic ratio)=PSV/EDF
次要结局
未报告次要终点
研究者
Montaser Ismail
Principal investigator
Minia University