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The goal of this interventional study is to investigate the role of beta-hCG levels in uterine cavity lavage for differentiating between ectopic pregnancy and early pregnancy loss in female patients aged 18-45 years. The main questions it aims to answer are as follows:
Researchers will compare beta-hCG levels in uterine cavity lavage to pathological results and final diagnoses to determine whether this method can provide a quick and accurate differentiation between ectopic pregnancy and early pregnancy loss.
Participants will:
The study focuses on patients with positive serum beta-hCG values, serum beta-hCG levels below the differential level (<1500-2000 mIU/mL), abnormal beta-hCG progression in consecutive measurements, and inconclusive transvaginal ultrasound results for differential diagnosis.
This study aims to investigate the potential of using beta-hCG levels in uterine cavity lavage as a diagnostic tool for differentiating between ectopic pregnancy and early pregnancy loss. The research focuses on female patients aged 18-45 years who present with positive serum beta-hCG values but inconclusive clinical findings and transvaginal ultrasound results.
The study will specifically target patients with serum beta-hCG levels below the differential level (typically <1500-2000 mIU/mL) and abnormal beta-hCG progression in consecutive measurements. These patients, who are scheduled for probe curettage (P/C), will undergo uterine cavity lavage prior to the procedure.
The lavage process involves administering 5 cc of saline solution into the uterine cavity before anesthesia and the P/C procedure. Subsequently, 3 cc of the aspirated liquid will be collected in a gel tube for beta-hCG level measurement.
The primary objective is to determine if there is a decisive cut-off value in the beta-hCG levels of the lavage fluid that can accurately differentiate between ectopic pregnancy and early pregnancy loss. This approach aims to provide a quick and minimally invasive diagnostic method, potentially reducing the need for more invasive procedures or operations.
The results of the beta-hCG measurements from the lavage fluid will be compared with the pathology results from the P/C and the final diagnosis. This comparison will help evaluate the accuracy and reliability of this novel diagnostic approach.
If successful, this method could offer a faster and less invasive way to distinguish between ectopic pregnancy and early pregnancy loss in cases where current diagnostic methods are inconclusive. This could potentially lead to earlier and more appropriate interventions, improving patient care and outcomes in early pregnancy complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| One arm; Patients with a β-hCG level of 1500-2000 mIU/mL with pregnancy of unknown location | Experimental | The study arm includes patients aged 18-45 with positive serum β-hCG and unclear clinical or ultrasound results. On the day of the intervention, a blood sample is collected to measure β-hCG levels, followed by the irrigation of the uterine cavity with 5 ml prior to the probe curettage (P/C).Three ml of wash fluid is collected for β-hCG measurement. After collecting the uterine lavage fluid samples, each specimen was frozen at -80 ºC and then all samples analyzed later, on the same day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beta-hCG levels in the uterine cavity lavage for differential diagnosis in pregnancy of unknown locations and ectopic pregnancy | Diagnostic Test | The intervention in this study centers on utilizing beta-hCG levels in uterine cavity lavage as a diagnostic tool to differentiate between ectopic pregnancy and early pregnancy loss.The procedure includes females aged 18-45 with positive serum beta-hCG, inconclusive clinical findings, and transvaginal ultrasound results, focusing on beta-hCG levels below 1500-2000 mIU/mL and abnormal progression.The intervention performed before probe curettage (P/C). Before the intervention beta-hCG is measured in venous blood. Patients undergo uterine cavity lavage with 5 ml of saline solution administered and 3 ml of aspirated liquid collected for beta-hCG measurement. Data collection involves beta-hCG levels from lavage fluid and venous blood, pathology results.After the samples were collected, each one was frozen at -80 ºC. All uterine lavage samples were then analyzed later on the same day. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of beta-hCG levels in simultaneously collected uterine lavage and venous blood with pathology results | Primary outcome include diagnostic accuracy, correlation between lavage fluid and venous blood beta-hCG levels and final diagnoses. | The time frame from patient enrollment in the intervention to the receipt of pathology results and comparison with intrauterine lavage results was an average of three weeks. |
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Inclusion Criteria:
Exclusion Criteria:
Women with Reproductive Age
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zeynep Kamil Women and Children Diseases Training and Research Hospital | Istanbul | Uskudar | 34668 | Turkey (Türkiye) |
Will be shared after complitation of primary outcomes
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This prospective study aims to evaluate the diagnostic potential of beta-hCG levels in uterine cavity lavage fluid for differentiating between ectopic pregnancy and early pregnancy loss. The study includes female patients aged 18-45 with positive serum beta-hCG, inconclusive diagnoses, and abnormal beta-hCG progression. Participants undergo uterine cavity lavage before scheduled probe curettage, with 5 cc of saline solution administered and 3 cc of aspirated liquid collected for beta-hCG measurement. Before the intervention beta-hCG is measured in venous blood.Data collection involves beta-hCG levels from lavage fluid, pathology results from curettage, and final diagnoses. Analysis compares lavage fluid beta-hCG levels with pathology results and final diagnoses to determine a potential cut-off value for differentiation. Outcome measures include diagnostic accuracy, correlation between lavage fluid beta-hCG levels and final diagnoses, and sensitivity/specificity of the proposed method.
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| ID | Term |
|---|---|
| D011271 | Pregnancy, Ectopic |
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D003937 | Diagnosis, Differential |
| ID | Term |
|---|---|
| D003933 | Diagnosis |
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