NCT07048587

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pregnancy, Ectopic
• Early Pregnancy Loss

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-06-12
• Primary completion: 2023-11-03
• Completion: 2023-11-03
• First posted: 2025-07-02
• Last updated: 2025-07-10

Locations

1 site across 1 country: Turkey (Türkiye)