Doppler Flow in Tubal Ectopic Pregnancy in Diagnosis as a Predictor of Treatment Success - Conservative and MTX Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ectopic Pregnancy. Basic parameters: 18 years — 45 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Primary outcome measures
- Doppler flow parameters [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 outcome measures (3)
- Prognostic significance of additional parameters related to the ectopic pregnancy- baseline characteristics [Time frame: 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 [Time frame: up to 10 weeks]
- Prognostic significance of additional parameters related to the ectopic pregnancy- Clinical and laboratory parameters [Time frame: up to 10 weeks]
Eligibility criteria
Inclusion criteria
- Tubal ectopic pregnancy
- Hemodynamically stable, with no suspicion of rupture,
- Eligible for MTX or conservative therapy.
Exclusion criteria
- Intrauterine pregnancy
- Hemodynamic instability
- Suspected tubal rupture
- Other ectopic pregnancy: CSP, Ovarian, heterotopic pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Israel · 1 center
- Meir Medical Center — Kfar Saba
Identifiers
NCT: NCT07541937 · 024-24-MMC