Novel Diagnosis of Ectopic Pregnancy

Not Applicable

Not yet recruiting

• Conditions: Pregnancy of Unknown Location; hCG; Ectopic Pregnancy
• Interventions: Diagnostic Test: serum BHCG testing

• Registration Number: NCT06486415
• Lead Sponsor: Acibadem University

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.

Study Timeline

• Study First Submitted: 2024-06-06
• Status Verified: 2024-07
• Study Start: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Last Update Submitted: 2024-07-01
• Study First Posted: 2024-07-03
• Last Update Posted: 2024-07-03
• Primary Completion: 2025-03-30
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Positive bhcg levels

Exclusion Criteria

• clinically diagnosis of intrauterine pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ectopic pregnancy patients	serum BHCG testing	the group diagnosed as ectopic pregnancy after serial testing of Beta Human Chorionic Gonadotropin (BHCG) levels
Normal pregnancy	serum BHCG testing	The group diagnosed with normal pregnancy after serial measurements of serum BHCG levels.

Primary Outcome Measures

Name	Time	Method
Changes in Beta-hCG Levels Measured Every 2 Hours as a Discriminating Factor Between Ectopic and Normal Pregnancy	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.

Secondary Outcome Measures

Name	Time	Method
Increase pattern of BHCG levels in normal pregnancy	10 hours	BHCG increase pattern every two hours in normal pregnancy