About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Tubal ectopic pregnancy
Hemodynamically stable, with no suspicion of rupture,
Eligible for MTX or conservative therapy.
Disqualifiers
Intrauterine pregnancy
Hemodynamic instability
Suspected tubal rupture
Other ectopic pregnancy: CSP, Ovarian, heterotopic pregnancy
Trial population
Women aged 18-45 diagnosed with tubal ectopic pregnancy who are hemodynamically stable, with no suspicion of rupture, and eligible for MTX or conservative therapy.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Doppler flow parameters
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.
Secondary outcomes
Prognostic significance of additional parameters related to the ectopic pregnancy- baseline characteristics
gestational age (days), mother age (years), and risk factors for ectopic pregnancy.
Prognostic significance of additional parameters related to the ectopic pregnancy- sonographic ectopic pregnancy parameters
yolk sac presence, embryonic pole presence, CRL(mm), fetal heartbeat.
Prognostic significance of additional parameters related to the ectopic pregnancy- Clinical and laboratory parameters
abdominal fluid (Mild/moderate/severe), pain severity (VAS 1-10), vaginal bleeding, and β-hCG levels.
Sponsors and contacts
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