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NCT Number: NCT07048587

Beta-HCG Levels in Uterine Cavity Lavage for Pregnancies of Unknown Location

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:

1. Can beta-hCG levels in uterine cavity lavage provide a decisive cut-off value for distinguishing between ectopic pregnancy and intrauterine pregnancy (early pregnancy loss)? 2. How do beta-hCG levels in uterine cavity lavage compare with venous blood beta-hCG levels and pathological results, final diagnoses?

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:

* Undergo uterine cavity lavage with 5 cc of saline solution before anesthesia and probe curettage * Have 3 cc of aspirated liquid collected in a gel tube for beta-hCG level measurement * Proceed with the scheduled probe curettage procedure

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.

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Key information

Conditions

Pregnancy, Ectopic Abortion, Spontaneous Early Pregnancy Loss Female Urogenital Diseases and Pregnancy Complications Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Zeynep Kamil Women and Children Diseases Training and Research Hospital

Istanbul, Uskudar, 34668, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age between 18 and 45
Beta-HCG positivity
Hemodynamically stable
Consecutive beta-hCG measurements do not show a normal pregnancy,
Beta-hCG is below the differential level (<1500-2000 mIU / mL) and TV-USG examination is insufficient for differential diagnosis

Exclusion criteria

Hemodynamic instability
Confirmed intrauterine pregnancy

Treatment and study plan

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.

Primary outcomes

Comparison of beta-hCG levels in simultaneously collected uterine lavage and venous blood with pathology results

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.

Primary outcome include diagnostic accuracy, correlation between lavage fluid and venous blood beta-hCG levels and final diagnoses.

Sponsors and collaborators

Lead sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Other

Registry information

Official study title

Evaluating the Diagnostic Efficacy of β-hCG Levels in Uterine Cavity Lavage: A Potential Tool for Identifying Pregnancies of Unknown Location (PUL) and Ectopic Pregnancies

Acronym: BHCG-UCL-DEP

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Jul 2, 2025
Registry last updated: Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed