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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-45
SponsorMeir Medical Center

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 1 trial group
Group A: Women diagnosed with tubal ectopic pregnancy who is a candidate for MTX or conservative therapy

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment at diagnosis until resolution of the ectopic pregnancy or need for surgical intervention during follow-up, up to 10 weeks.

Secondary outcomes

1

Prognostic significance of additional parameters related to the ectopic pregnancy- baseline characteristics

gestational age (days), mother age (years), and risk factors for ectopic pregnancy.

Time frame
From enrollment to the end of the follow-up of the ectopic pregnancy, up to 10 weeks.
2

Prognostic significance of additional parameters related to the ectopic pregnancy- sonographic ectopic pregnancy parameters

yolk sac presence, embryonic pole presence, CRL(mm), fetal heartbeat.

Time frame
up to 10 weeks
3

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.

Time frame
up to 10 weeks

Other outcomes

Sponsors and contacts

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