Novel Diagnosis of Ectopic Pregnancy

NCT06486415 | Not Yet Recruiting

• 1 other identifier: Acibadem Ob&Gyn
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ectopic Pregnancy; hCG; Pregnancy of Unknown Location

Keywords

ectopic pregnancy; hCG; Pregnancy with unknown location

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Increase pattern of BHCG levels in normal pregnancy

  10 hours

Study Arms (2)

ectopic pregnancy patients

EXPERIMENTAL

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

Diagnostic Test: serum BHCG testing

Normal pregnancy

ACTIVE COMPARATOR

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

Diagnostic Test: serum BHCG testing

Interventions

serum BHCG testing 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; ectopic pregnancy patients

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Positive bhcg levels

You may not qualify if:

• clinically diagnosis of intrauterine pregnancy

Sponsors & Collaborators

• Acibadem University: lead

MeSH Terms

Conditions

Pregnancy, Ectopic

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Ozguc Takmaz, Assoc.Prof.

  Acibadem Maslak Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ozguc Takmaz, Assoc.Prof.

CONTACT

+905554006591; ozguctakmaz@hotmail.com

Mete Gungor, Prof.

CONTACT

+902123044970; mtgungor@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: July 3, 2024
• Study Start: July 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: April 1, 2025
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after submission of the trail results to a scientific journal.
• Access Criteria: Data will be shared in a publicly accessible web site.