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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women diagnosed with tubal ectopic pregnancy who is a candidate for MTX or conservative therapy |
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| 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. |
| 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 |
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Inclusion criteria:
Exclusion criteria:
pregnancy
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen Manor Bar, MD | Contact | +972544414211 | manor.chen@gmail.com | |
| yael Yagur, MD | Contact | +972523309429 | yael.yagur@clalit.org.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meir Medical Center | Recruiting | Kfar Saba | Israel | 4861027 | Israel |
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| ID | Term |
|---|---|
| D011271 | Pregnancy, Ectopic |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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 |