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NCT Number: NCT07541937

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

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.

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Key information

Conditions

Ectopic Pregnancy Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Pregnancy, Ectopic Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

    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

  1. 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.

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

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

    Time frame: up to 10 weeks

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

  3. Prognostic significance of additional parameters related to the ectopic pregnancy- Clinical and laboratory parameters

    Time frame: up to 10 weeks

    abdominal fluid (Mild/moderate/severe), pain severity (VAS 1-10), vaginal bleeding, and β-hCG levels.

Study contacts

Contact information is provided by the study sponsor or research team.

Chen Manor Bar, MD

CONTACT

[email protected]

+972544414211

yael Yagur, MD

CONTACT

[email protected]

+972523309429

Sponsors and collaborators

Lead sponsor

Meir Medical Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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