Novel Diagnosis of Ectopic Pregnancy

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Ectopic Pregnancy; hCG; Pregnancy of Unknown Location
• Intervention / Treatment: Diagnostic test: serum BHCG testing

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ozguc Takmaz, Assoc.Prof.; Phone Number: +905554006591; Email: ozguctakmaz@hotmail.com
• Study Contact Backup: Name: Mete Gungor, Prof.; Phone Number: +902123044970; Email: mtgungor@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Positive bhcg levels

Exclusion Criteria:

• clinically diagnosis of intrauterine pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ectopic pregnancy patients; the group diagnosed as ectopic pregnancy after serial testing of Beta Human Chorionic Gonadotropin (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.
Active Comparator: Normal pregnancy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Increase pattern of BHCG levels in normal pregnancy	BHCG increase pattern every two hours in normal pregnancy	10 hours

Collaborators and Investigators

• Sponsor: Acibadem University
• Investigators: Principal Investigator: Ozguc Takmaz, Assoc.Prof., Acibadem Maslak Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: hCG; ectopic pregnancy; Pregnancy with unknown location
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy, Ectopic; Cardiac Complexes, Premature
• Other Study ID Numbers: Acibadem Ob&Gyn

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: If requested, data will be shared
• IPD Sharing Time Frame: Data will be available after submission of the trail results to a scientific journal.
• IPD Sharing Access Criteria: Data will be shared in a publicly accessible web site.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No