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

Not Applicable

Completed

• Conditions: Pregnancy, Ectopic; Early Pregnancy Loss

• Registration Number: NCT07048587
• Lead Sponsor: Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Brief 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.

Study Timeline

• Study Start: 2020-06-12
• Primary Completion: 2023-11-03
• Study Completion: 2023-11-03
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-06-29
• Status Verified: 2025-07
• Study First Posted: 2025-07-02
• Last Update Submitted: 2025-07-04
• Last Update Posted: 2025-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 121

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Zeynep Kamil Women and Children Diseases Training and Research Hospital; 🇹🇷 Istanbul, Uskudar, Turkey