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Идёт набор NCT07541937

Doppler Flow in Tubal Ectopic Pregnancy in Diagnosis as a Predictor of Treatment Success - Conservative and MTX Treatment

— Наблюдательное Ectopic Pregnancy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Ectopic Pregnancy. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Израиль
Следующий шаг
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Обзор

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.

Подробное описание

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:

* Women aged 18-45 diagnosed with tubal ectopic pregnancy. * Inclusion and exclusion criteria based on stability, location of ectopic pregnancy, and lack of rupture suspicion.

Sample Size:

Based on previous studies, 60 participants (to allow for 10% loss to follow-up) will provide 80% statistical power to evaluate Doppler parameters as predictors of treatment success.

This study aims to address the gap in the literature regarding the role of Doppler vascularization in predicting treatment outcomes for tubal ectopic pregnancy.

Первичные конечные точки

  • Doppler flow parameters [Срок оценки: From enrollment at diagnosis until resolution of the ectopic pregnancy or need for surgical intervention during follow-up, up to 10 weeks.]
Вторичные конечные точки (3)
  • Prognostic significance of additional parameters related to the ectopic pregnancy- baseline characteristics [Срок оценки: 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 [Срок оценки: up to 10 weeks]
  • Prognostic significance of additional parameters related to the ectopic pregnancy- Clinical and laboratory parameters [Срок оценки: up to 10 weeks]

Критерии участия

Критерии включения

  • Tubal ectopic pregnancy
  • Hemodynamically stable, with no suspicion of rupture,
  • Eligible for MTX or conservative therapy.

Критерии исключения

  • Intrauterine pregnancy
  • Hemodynamic instability
  • Suspected tubal rupture
  • Other ectopic pregnancy: CSP, Ovarian, heterotopic pregnancy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Израиль · 1 центр
  • Meir Medical Center — Kfar Saba

Идентификаторы

NCT: NCT07541937 · 024-24-MMC

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗