Skip to content

Novel Diagnosis of Ectopic Pregnancy

Serial Measurement of Beta-Human Chorionic Gonadotropin (BHCG) Values During the Day in the Diagnosis of Ectopic Pregnancy

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06486415
Enrollment
20
Registered
2024-07-03
Start date
2024-07-01
Completion date
2025-04-01
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ectopic Pregnancy, hCG, Pregnancy of Unknown Location

Keywords

ectopic pregnancy, hCG, Pregnancy with unknown location

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTserum 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.

Sponsors

Acibadem University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Positive bhcg levels

Exclusion criteria

* clinically diagnosis of intrauterine pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Changes in Beta-hCG Levels Measured Every 2 Hours as a Discriminating Factor Between Ectopic and Normal Pregnancy10 hoursThe primary outcome is how the changes in Beta-hCG levels measured every two hours differ between the ectopic pregnancy and the normal pregnancy.

Secondary

MeasureTime frameDescription
Increase pattern of BHCG levels in normal pregnancy10 hoursBHCG increase pattern every two hours in normal pregnancy

Contacts

Primary ContactOzguc Takmaz, Assoc.Prof.
ozguctakmaz@hotmail.com+905554006591
Backup ContactMete Gungor, Prof.
mtgungor@gmail.com+902123044970

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026