An interventional study of serum BHCG testing in Ectopic Pregnancy, hCG and Pregnancy of Unknown Location, sponsored by Acibadem University. Not yet recruiting. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Acibadem University · Not applicable, Interventional, and Diagnostic
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.
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.
83 studies on the registry are indexed under Pregnancy, Ectopic; 21 are open to participants now.
This study's planned enrollment of 20 is below the median of 100 across 43 interventional studies indexed under Pregnancy, Ectopic.
Browse Pregnancy, Ectopic studies →Acibadem University is the lead sponsor of 220 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
the group diagnosed as ectopic pregnancy after serial testing of Beta Human Chorionic Gonadotropin (BHCG) levels
Diagnostic Test: serum BHCG testing
The group diagnosed with normal pregnancy after serial measurements of serum BHCG levels.
Diagnostic Test: serum BHCG testing
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.
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.
Time frame: 10 hours
Increase pattern of BHCG levels in normal pregnancy
BHCG increase pattern every two hours in normal pregnancy
Time frame: 10 hours
No study locations are listed for this record.
Plan to share: Yes — If requested, data will be shared
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data will be available after submission of the trail results to a scientific journal.
Access criteria: Data will be shared in a publicly accessible web site.
No publications or documents are linked to this record.
Start is estimated for Jul 2024; primary completion for Mar 2025, 8 months later.
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This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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