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

Clalit Health Services

Status

Enrolling

Conditions

Ectopic Pregnancy

Study type

Observational

Funder types

Other

Identifiers

NCT07541937

024-24-MMC

Details and patient eligibility

About

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.

Full description

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.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria