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Clinical Trials/NCT04371991
NCT04371991
Completed
Not Applicable

Can Kisspeptin be Used for Differential Diagnosis of Early Pregnancies?

Semra Yuksel1 site in 1 country88 target enrollmentJanuary 5, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Early Pregnancy
Sponsor
Semra Yuksel
Enrollment
88
Locations
1
Primary Endpoint
Kisspeptin levels in early pregnancy
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Kisspeptins are a family of neuropeptides that are critical for the puberty initiation and female fertility. The investigators aimed to investigate in this study kisspeptin levels in early pregnancy, ectopic pregnancy, and early pregnancy loss.

Detailed Description

Clinicians can easily do a differential diagnosis of early pregnancy, miscarriage, and ectopic pregnancy when the human chorionic gonadotropin (hCG) values higher than 2000 mIU/mL with transvaginal ultrasound. However, in cases where the hCG value is below the critical threshold of 1500 to 2000 mIU/mL (often called the discrimination level) and ultrasound is not likely to be diagnostic, the pregnancy is of unknown location. Plasma or serum kisspeptin is mainly derived from the placenta during pregnancy and plasma kisspeptin levels significantly increase across pregnancy. Plasma kisspeptin levels could be used as a potential biomarker for the discrimination of miscarriage and ectopic pregnancy. All statistics will be carried out with the use of SPSS (ver. 21, IBM). A P value of \<.05 is considered to be statistically significant. Pearson chi-square test will be used to evaluate between-group differences by pregnancy outcome for categoric data. Kisspeptin differences will be calculated between groups with one way ANOVA.

Registry
clinicaltrials.gov
Start Date
January 5, 2019
End Date
November 5, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Semra Yuksel
Responsible Party
Sponsor Investigator
Principal Investigator

Semra Yuksel

Principal investigator, MD

Gaziosmanpasa Research and Education Hospital

Eligibility Criteria

Inclusion Criteria

  • Women aged between 18-37 years presented with between 5-6 weeks of gestation by last menstrual period.

Exclusion Criteria

  • Women older than 37 years or younger than 18 years
  • Women with a molar pregnancy, multiple gestations, gestational age past 6 weeks at the time of blood draw, or if pregnancies were assisted conceptions

Outcomes

Primary Outcomes

Kisspeptin levels in early pregnancy

Time Frame: January 2019-January 2020

Kisspeptin levels can be used for discrimination between ectopic pregnancy and incomplete miscarriage.

Study Sites (1)

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