Novel Diagnosis of Ectopic Pregnancy

NCT ID: NCT06486415

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-04-01

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.

Conditions

Ectopic Pregnancy; hCG; Pregnancy of Unknown Location

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ectopic pregnancy patients

the group diagnosed as ectopic pregnancy after serial testing of Beta Human Chorionic Gonadotropin (BHCG) levels

Group Type: EXPERIMENTAL

serum BHCG testing

Intervention Type: DIAGNOSTIC_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.

Normal pregnancy

The group diagnosed with normal pregnancy after serial measurements of serum BHCG levels.

Group Type: ACTIVE_COMPARATOR

serum BHCG testing

Intervention Type: DIAGNOSTIC_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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Positive bhcg levels

Exclusion Criteria

• clinically diagnosis of intrauterine pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Acibadem University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ozguc Takmaz, Assoc.Prof.

Role: PRINCIPAL_INVESTIGATOR

Acibadem Maslak Hospital

Central Contacts

Ozguc Takmaz, Assoc.Prof.

Role: CONTACT

ozguctakmaz@hotmail.com

+905554006591

Mete Gungor, Prof.

Role: CONTACT

mtgungor@gmail.com

+902123044970

Other Identifiers

Acibadem Ob&Gyn

Identifier Type: -

Identifier Source: org_study_id