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.

Study Overview

• Status: Recruiting
• Conditions: Ectopic Pregnancy

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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Chen Manor Bar, MD; Phone Number: +972544414211; Email: manor.chen@gmail.com
• Study Contact Backup: Name: yael Yagur, MD; Phone Number: +972523309429; Email: yael.yagur@clalit.org.il

Study Locations

• Israel
  • Israel
    • Kfar Saba, Israel, Israel, 4861027
      • Recruiting
      • Meir Medical Center
      • Contact: Chen Manor Bar, MD; Phone Number: +972544414211; Email: manor.chen@gmail.com
      • Contact: yael yagur, MD; Phone Number: +972523309429; Email: yaelyagur@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Women diagnosed with tubal ectopic pregnancy who is a candidate for MTX or conservative therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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

Outcome Measure	Measure Description	Time Frame
Prognostic significance of additional parameters related to the ectopic pregnancy- baseline characteristics	gestational age (days), mother age (years), and risk factors for ectopic pregnancy.	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	yolk sac presence, embryonic pole presence, CRL(mm), fetal heartbeat.	up to 10 weeks
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.	up to 10 weeks

Collaborators and Investigators

• Sponsor: Meir Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 1, 2024
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: ectopic pregnancy conservative management; Ectopic pregnancy MTX therapy; Doppler flow parameters in ectopic pregnancy
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Pregnancy, Ectopic
• Other Study ID Numbers: 024-24-MMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No