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NCT Number: NCT06486415

Novel 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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Positive bhcg levels

Exclusion criteria

  • clinically diagnosis of intrauterine pregnancy

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. Increase pattern of BHCG levels in normal pregnancy

    Time frame: 10 hours

    BHCG increase pattern every two hours in normal pregnancy

Study contacts

Contact information is provided by the study sponsor or research team.

Mete Gungor, Prof.

CONTACT

[email protected]

+902123044970

Ozguc Takmaz, Assoc.Prof.

CONTACT

[email protected]

+905554006591

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 3, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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