Pregnancy, EctopicBHCG-UCL-DEPNCT07048587
Beta-HCG Levels in Uterine Cavity Lavage for Pregnancies of Unknown Location
A study testing Beta-hCG levels in the uterine cavity lavage for differential diagnosis in pregnancy of unknown locations and ectopic pregnancy in people with Pregnancy, Ectopic and Early Pregnancy Loss, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy, Ectopic, Early Pregnancy Loss
- What is being tested?
- Beta-hCG levels in the uterine cavity lavage for differential diagnosis in pregnancy of unknown locations and ectopic pregnancy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jun 2020to 3 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Hemodynamic instability
- Confirmed intrauterine pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Women and Children Diseases Training and Research Hospital
Istanbul, Uskudar, 34668
About this study
Official 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
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:
- 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)?
- How do beta-hCG levels in uterine cavity lavage compare with venous blood beta-hCG levels and pathological results, final diagnoses?
Read more
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.
Read the 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
- Being tested
- Beta-hCG levels in the uterine cavity lavage for differential diagnosis in pregnancy of unknown locations and ectopic pregnancy
- Keywords
- ectopic pregnancy, beta-hCG, early pregnancy loss, uterine cavity lavage
- Medical subject headings
- Pregnancy, Ectopic, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-hCG levels in the uterine cavity lavage for differential diagnosis in pregnancy of unknown locations and ectopic pregnancyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Beta-hCG levels in the uterine cavity lavage for differential diagnosis in pregnancy of unknown locations and ectopic pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start12 Jun 2020
- Primary completion3 Nov 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, EctopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reyyan Gokcen Iscan, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048587
- Sponsor's protocol ID
- 2020-101
- Acronym
- BHCG-UCL-DEP
- Status last verified
- Jul 2025
- First submitted
- 7 May 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will be shared after complitation of primary outcomes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07048587
- Acronym / sponsor ID
- BHCG-UCL-DEP / 2020-101
- Conditions
- Pregnancy, Ectopic, Early Pregnancy Loss
- Keywords
- ectopic pregnancy, beta-hCG, early pregnancy loss, uterine cavity lavage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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)?
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| One arm; Patients with a β-hCG level of 1500-2000 mIU/mL with pregnancy of unknown location | Experimental | Diagnostic Test: Beta-hCG levels in the uterine cavity lavage for differential diagnosis in pregnancy of unknown locations and ectopic pregnancyThe 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Hemodynamic instability
- Confirmed intrauterine pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-hCG levels in the uterine cavity lavage for differential diagnosis in pregnancy of unknown locations and ectopic pregnancyThe 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. | Diagnostic test | One arm; Patients with a β-hCG level of 1500-2000 mIU/mL with pregnancy of unknown location |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No. Will be shared after complitation of primary outcomes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beta-hCG levels in the uterine cavity lavage for differential diagnosis in pregnancy of unknown locations and ectopic pregnancy in people with Pregnancy, Ectopic and Early Pregnancy Loss, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.