Novel Diagnosis of Ectopic Pregnancy | NCT06486415

Studies
Novel Diagnosis of Ectopic Pregnancy

NCT06486415

Sponsor

Acibadem University

Status

Not yet recruiting

Last Update Posted

Jul 3, 2024Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Ectopic Pregnancy
hCG
Pregnancy of Unknown Location

Interventions

serum BHCG testing

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2024Estimated

Primary Completion Date

Mar 30, 2025Estimated

Completion Date

Apr 1, 2025Estimated

First Submitted Date

Jun 6, 2024

First Submission Date that Met QC Criteria

Jul 1, 2024

First Posted Date

Jul 3, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2024

Last Update Posted Date

Jul 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Positive bhcg levels

Exclusion Criteria:

clinically diagnosis of intrauterine pregnancy

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ozguc Takmaz, Assoc.Prof.	Contact	+905554006591		ozguctakmaz@hotmail.com
Mete Gungor, Prof.	Contact	+902123044970		mtgungor@gmail.com

Overall Officials

Name	Affiliation	Role
Ozguc Takmaz, Assoc.Prof.	Acibadem Maslak Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

If requested, data will be shared

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011271	Pregnancy, Ectopic

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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.