Ectopic PregnancyNCT06486415
Novel Diagnosis of Ectopic Pregnancy
A study testing serum BHCG testing in people with Ectopic Pregnancy and hCG, run by Acibadem University.
Trial summary
In the project, the investigators aim to determine the Beta- human chorionic gonadotropin (BHCG) value with serial measurements on the same day in the diagnosis of ectopic pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ectopic Pregnancy, hCG, Pregnancy of Unknown Location
- What is being tested?
- serum BHCG testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2024to 1 Apr 2025
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Positive bhcg levels
Who cannot join
- clinically diagnosis of intrauterine pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Serial Measurement of Beta-Human Chorionic Gonadotropin (BHCG) Values During the Day in the Diagnosis of Ectopic Pregnancy
In the project, the investigators aim to determine the Beta- human chorionic gonadotropin (BHCG) value with serial measurements on the same day in the diagnosis of ectopic pregnancy.
Read the detailed description
Ectopic pregnancy is when the conception material is in a location other than the endometrial cavity. The diagnosis of ectopic pregnancy is basically made by the lack of increase in serum BHCG values as in normal pregnancy. In normal pregnancies, BHCG value increases by 70% or more every 2 days. In ectopic pregnancy, an increase of less than 70% every 2 days is diagnostic. This classical method allows the diagnosis to be made within 2-4 days at the earliest. Most of the time, this period can take 6-10 days.
In the project, the investigators will investigate how to determine the BHCG value with serial measurements on the same day in the diagnosis of ectopic pregnancy. The fact that there is no 70% increase after 2 days in ectopic pregnancy suggests that there may be an irregular increase during the day. The investigators aim to make this diagnosis in a shorter time than long days by measuring BHCG values many times during the day in patients with suspected ectopic pregnancy. The fact that there is no other study on this subject in the literature strengthens the possibility of the project being published as valuable information for the literature, even if a negative result is obtained as a result of this study.
- Conditions
- Ectopic Pregnancy, hCG, Pregnancy of Unknown Location
- Being tested
- serum BHCG testing
- Keywords
- ectopic pregnancy, hCG, Pregnancy with unknown location
- Medical subject headings
- Pregnancy, Ectopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serum BHCG testingDiagnostic test
Taking 5ml blood samples every 2 hours for 5 times for measurement of BHCG. Blood samples will be taken from the median cubital and cephalic veins which is located inner side of the elbow.
| Study group | Role | What they receive |
|---|---|---|
| ectopic pregnancy patients | Experimental | the group diagnosed as ectopic pregnancy after serial testing of Beta Human Chorionic Gonadotropin (BHCG) levels Receives: Diagnostic Test: serum BHCG testing |
| Normal pregnancy | Active comparator | The group diagnosed with normal pregnancy after serial measurements of serum BHCG levels. Receives: Diagnostic Test: serum BHCG testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Beta-hCG Levels Measured Every 2 Hours as a Discriminating Factor Between Ectopic and Normal Pregnancy
The primary outcome is how the changes in Beta-hCG levels measured every two hours differ between the ectopic pregnancy and the normal pregnancy.
Measured: 10 hours
Secondary outcomes (1)
Increase pattern of BHCG levels in normal pregnancy
BHCG increase pattern every two hours in normal pregnancy
Measured: 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start1 Jul 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ectopic PregnancyStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- In participants with clinically suspected ectopic pregnancy who come to the Gynecology clinic with menstrual delay and high Beta Human Chorionic Gonadotropin (BHCG) levels, serum BHCG values will be checked 5 times with 2-hour intervals on the same day. 10 ectopic pregnancy and 10 normal pregnancy patients will be included in the study. The serum BHCG increase trend of patients whose normal pregnancy was clinically detected by ultrasound despite the suspicion of ectopic pregnancy, and the change trend in serum BHCG of patients whose diagnosis of ectopic pregnancy is confirmed will be analyzed and compared. Diagnostic criteria for BHCG change in ectopic pregnancy will be established according to the differences in the serum BHCG increase trend. This is an interventional study. Taking 5 blood samples of the ectopic pregnancy patients in the same day are the interventions of the study.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ozguc Takmaz, Assoc.Prof., Principal investigator, Acibadem Maslak Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486415
- Sponsor's protocol ID
- Acibadem Ob&Gyn
- Status last verified
- Jul 2024
- First submitted
- 6 Jun 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If requested, data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Measurement of Beta-Human Chorionic Gonadotropin (BHCG) Values During the Day in the Diagnosis of Ectopic Pregnancy
- ClinicalTrials.gov ID
- NCT06486415
- Acronym / sponsor ID
- Acibadem Ob&Gyn
- Conditions
- Ectopic Pregnancy, hCG, Pregnancy of Unknown Location
- Keywords
- ectopic pregnancy, hCG, Pregnancy with unknown location
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 3 Jul 2024 (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.
In the project, the investigators aim to determine the Beta- human chorionic gonadotropin (BHCG) value with serial measurements on the same day in the diagnosis of ectopic pregnancy.
Detailed description
Ectopic pregnancy is when the conception material is in a location other than the endometrial cavity. The diagnosis of ectopic pregnancy is basically made by the lack of increase in serum BHCG values as in normal pregnancy. In normal pregnancies, BHCG value increases by 70% or more every 2 days. In ectopic pregnancy, an increase of less than 70% every 2 days is diagnostic. This classical method allows the diagnosis to be made within 2-4 days at the earliest. Most of the time, this period can take 6-10 days.
In the project, the investigators will investigate how to determine the BHCG value with serial measurements on the same day in the diagnosis of ectopic pregnancy. The fact that there is no 70% increase after 2 days in ectopic pregnancy suggests that there may be an irregular increase during the day. The investigators aim to make this diagnosis in a shorter time than long days by measuring BHCG values many times during the day in patients with suspected ectopic pregnancy. The fact that there is no other study on this subject in the literature strengthens the possibility of the project being published as valuable information for the literature, even if a negative result is obtained as a result of this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In participants with clinically suspected ectopic pregnancy who come to the Gynecology clinic with menstrual delay and high Beta Human Chorionic Gonadotropin (BHCG) levels, serum BHCG values will be checked 5 times with 2-hour intervals on the same day. 10 ectopic pregnancy and 10 normal pregnancy patients will be included in the study. The serum BHCG increase trend of patients whose normal pregnancy was clinically detected by ultrasound despite the suspicion of ectopic pregnancy, and the change trend in serum BHCG of patients whose diagnosis of ectopic pregnancy is confirmed will be analyzed and compared. Diagnostic criteria for BHCG change in ectopic pregnancy will be established according to the differences in the serum BHCG increase trend. This is an interventional study. Taking 5 blood samples of the ectopic pregnancy patients in the same day are the interventions of the study.
| Arm | Type | Receives |
|---|---|---|
| ectopic pregnancy patients | Experimental | Diagnostic Test: serum BHCG testingthe group diagnosed as ectopic pregnancy after serial testing of Beta Human Chorionic Gonadotropin (BHCG) levels |
| Normal pregnancy | Active comparator | Diagnostic Test: serum BHCG testingThe group diagnosed with normal pregnancy after serial measurements of serum BHCG levels. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Positive bhcg levels
Key exclusion criteria (1 listed)
- clinically diagnosis of 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 |
|---|---|---|
| serum BHCG testingTaking 5ml blood samples every 2 hours for 5 times for measurement of BHCG. Blood samples will be taken from the median cubital and cephalic veins which is located inner side of the elbow. | Diagnostic test | Normal pregnancy, ectopic pregnancy patients |
Primary outcome
Changes in Beta-hCG Levels Measured Every 2 Hours as a Discriminating Factor Between Ectopic and Normal Pregnancy
Time frame: 10 hours
The primary outcome is how the changes in Beta-hCG levels measured every two hours differ between the ectopic pregnancy and the normal pregnancy.
1 secondary outcome
Increase pattern of BHCG levels in normal pregnancy
Time frame: 10 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: Yes. If requested, data will be shared
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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.
Ozguc Takmaz, Assoc.Prof. principal investigator
Acibadem Maslak Hospital
Questions about this trial
What is this clinical trial studying?
A study testing serum BHCG testing in people with Ectopic Pregnancy and hCG, run by Acibadem University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ozguc Takmaz, Assoc.Prof. (+905554006591, ozguctakmaz@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Beta-hCG Levels Measured Every 2 Hours as a Discriminating Factor Between Ectopic and Normal Pregnancy (time frame: 10 hours). 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 3 Jul 2024.