Clinical trial NCT06486415: Novel Diagnosis of Ectopic Pregnancy
Official title: Serial Measurement of Beta-Human Chorionic Gonadotropin (BHCG) Values During the Day in the Diagnosis of Ectopic Pregnancy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ectopic Pregnancy
hCG
Pregnancy of Unknown Location
Keywords: ectopic pregnancy
hCG
Pregnancy with unknown location
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* Positive bhcg levels

Exclusion Criteria:

* clinically diagnosis of intrauterine pregnancy

Primary outcomes:
measure: Changes in Beta-hCG Levels Measured Every 2 Hours as a Discriminating Factor Between Ectopic and Normal Pregnancy
timeFrame: 10 hours
Secondary outcomes:
measure: Increase pattern of BHCG levels in normal pregnancy
timeFrame: 10 hours
Other outcomes:
Locations:
Study officials:
affiliation: Acibadem Maslak Hospital
name: Ozguc Takmaz, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References: