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

NCT07541937 | Recruiting

• 1 other identifier: 024-24-MMC
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ectopic Pregnancy

Keywords

ectopic pregnancy conservative management; Ectopic pregnancy MTX therapy; Doppler flow parameters in ectopic pregnancy

Outcome Measures

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.

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

Secondary Outcomes (3)

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

  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

  up to 10 weeks

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

  up to 10 weeks

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Tubal ectopic pregnancy
• Hemodynamically stable, with no suspicion of rupture,
• Eligible for MTX or conservative therapy.

You may not qualify if:

• Intrauterine pregnancy
• Hemodynamic instability
• Suspected tubal rupture
• Other ectopic pregnancy: CSP, Ovarian, heterotopic pregnancy

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel, 4861027, Israel

RECRUITING

MeSH Terms

Conditions

Pregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Chen Manor Bar, MD

CONTACT

+972544414211; manor.chen@gmail.com

yael Yagur, MD

CONTACT

+972523309429; yael.yagur@clalit.org.il

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: April 21, 2026
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)