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

NCT07048587 | Completed

• 1 other identifier: 2020-101
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Pregnancy, Ectopic; Early Pregnancy Loss

Keywords

ectopic pregnancy, beta-hCG, early pregnancy loss, uterine cavity lavage

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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.

Diagnostic Test: Beta-hCG levels in the uterine cavity lavage for differential diagnosis in pregnancy of unknown locations and ectopic pregnancy

Interventions

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.

One arm; Patients with a β-hCG level of 1500-2000 mIU/mL with pregnancy of unknown location

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women with Reproductive Age
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Hemodynamic instability
• Confirmed intrauterine pregnancy

Sponsors & Collaborators

• Zeynep Kamil Maternity and Pediatric Research and Training Hospital: lead

Study Sites (1)

Zeynep Kamil Women and Children Diseases Training and Research Hospital

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pregnancy, Ectopic; Abortion, Spontaneous

Interventions

Diagnosis, Differential

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnosis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant gynecologist and obstetrician, MD

Model Details: 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.

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: July 2, 2025
• Study Start: June 12, 2020
• Primary Completion: November 3, 2023
• Study Completion: November 3, 2023
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)