An observational study in Ectopic Pregnancy, sponsored by Meir Medical Center. Recruiting at 1 site in Israel. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Meir Medical Center · Observational
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 Objectives:
Study Design:
Population:
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.
83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.
This study's planned enrollment of 60 is below the median of 150 across 39 observational studies indexed under Pregnancy, Ectopic.
Browse Pregnancy, Ectopic studies →Meir Medical Center is the lead sponsor of 401 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
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.
Time frame: From enrollment at diagnosis until resolution of the ectopic pregnancy or need for surgical intervention during follow-up, up to 10 weeks.
Prognostic significance of additional parameters related to the ectopic pregnancy- baseline characteristics
gestational age (days), mother age (years), and risk factors for ectopic pregnancy.
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
yolk sac presence, embryonic pole presence, CRL(mm), fetal heartbeat.
Time frame: 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.
Time frame: up to 10 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2024 (actual). Primary completion is estimated for Jun 2027, 36 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.