Doppler Flow in Tubal Ectopic Pregnancy in Diagnosis as a Predictor of Treatment Success - Conservative and MTX Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Doppler flow parameters
研究概览
简要总结
The study "Doppler Flow in Tubal Ectopic Pregnancy as a Predictor of Treatment Success: Conservative and MTX Therapy" aims to evaluate the role of Doppler ultrasound parameters (RI, PI, and PSV) in predicting treatment success for tubal ectopic pregnancies. Ectopic pregnancies, affecting ~2% of all pregnancies (98% in fallopian tubes), pose significant risks, including rupture and maternal mortality. Diagnosis is typically achieved via transvaginal ultrasound, with Doppler imaging enhancing accuracy by detecting characteristic vascular patterns.
Management options include conservative monitoring, methotrexate (MTX) therapy, or surgery, based on clinical stability, β-hCG levels, and ultrasound findings. While β-hCG levels are a known predictor of MTX treatment failure, there is no consensus on an optimal threshold. Prior research suggests increased vascularization on Doppler ultrasound may correlate with higher MTX success rates.
This prospective study will involve 60 women aged 18-45 with stable, unruptured tubal ectopic pregnancies. It will assess Doppler parameters and other clinical factors as predictors of treatment success. Findings aim to address gaps in the literature and improve management strategies for tubal ectopic pregnancies.
详细描述
Study Objectives:
- Primary Objectives: Assess the predictive value of Doppler flow parameters (RI, PI, and PSV) at diagnosis for conservative management success or MTX therapy success in tubal ectopic pregnancies.
- Secondary Objectives: Evaluate the predictive value of additional parameters such as gestational age, yolk sac presence, embryonic pole presence, CRL, fetal heartbeat, abdominal fluid, pain severity, vaginal bleeding, and β-hCG levels.
Study Design:
- Prospective study including women diagnosed with tubal ectopic pregnancy.
- Participants must be hemodynamically stable with no suspicion of tubal rupture.
- Doppler parameters and clinical/laboratory data will be recorded at diagnosis, followed by treatment based on departmental protocols.
Population:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Tubal ectopic pregnancy
- •Hemodynamically stable, with no suspicion of rupture,
- •Eligible for MTX or conservative therapy.
排除标准
- •Intrauterine pregnancy
- •Hemodynamic instability
- •Suspected tubal rupture
- •Other ectopic pregnancy: CSP, Ovarian, heterotopic pregnancy
研究组 & 干预措施
Women diagnosed with tubal ectopic pregnancy who is a candidate for MTX or conservative therapy
结局指标
主要结局
Doppler flow parameters
时间窗: From enrollment at diagnosis until resolution of the ectopic pregnancy or need for surgical intervention during follow-up, up to 10 weeks.
To assess whether Doppler flow parameters measured at the time of diagnosis, including resistance index (RI), pulsatility index (PI), and peak systolic velocity (PSV), are associated with successful treatment outcome in women with tubal ectopic pregnancy managed either conservatively or with methotrexate (MTX). Treatment success will be defined as resolution of the ectopic pregnancy without the need for surgical intervention.
次要结局
- Prognostic significance of additional parameters related to the ectopic pregnancy- baseline characteristics(From enrollment to the end of the follow-up of the ectopic pregnancy, up to 10 weeks.)
- Prognostic significance of additional parameters related to the ectopic pregnancy- sonographic ectopic pregnancy parameters(up to 10 weeks)
- Prognostic significance of additional parameters related to the ectopic pregnancy- Clinical and laboratory parameters(up to 10 weeks)