An interventional study of Beta-hCG levels in the uterine cavity lavage for differential diagnosis in pregnancy of unknown locations and ectopic pregnancy in Pregnancy, Ectopic and Early Pregnancy Loss, sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by Zeynep Kamil Maternity and Pediatric Research and Training Hospital · Not applicable, Interventional, and Diagnostic
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.
83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.
This study's enrollment of 121 is above the median of 100 across 43 interventional studies indexed under Pregnancy, Ectopic.
Browse Pregnancy, Ectopic studies →Zeynep Kamil Maternity and Pediatric Research and Training Hospital is the lead sponsor of 38 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
Diagnostic Test: Beta-hCG levels in the uterine cavity lavage for differential diagnosis in pregnancy of unknown locations and ectopic pregnancy
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.
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.
Time frame: 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.
Plan to share: No — Will be shared after complitation of primary outcomes
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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Zeynep Kamil Maternity and Pediatric Research and Training Hospital