Kisspeptin Levels in Early Pregnancy

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Brief Title

Kisspeptin Levels in Early Pregnancy

Official Title

Can Kisspeptin be Used for Differential Diagnosis of Early Pregnancies?

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.
    


Study Type

Observational [Patient Registry]


Primary Outcome

Kisspeptin levels in early pregnancy


Condition

Early Pregnancy

Intervention

blood test

Study Arms / Comparison Groups

 Group 1
Description:  Ectopic pregnancy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

88

Start Date

January 5, 2019

Completion Date

November 5, 2019

Primary Completion Date

August 1, 2019

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
      

Gender

Female

Ages

18 Years - 37 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

sibel bektas, proffessor, , 

Location Countries

Turkey

Location Countries

Turkey

Administrative Informations


NCT ID

NCT04371991

Organization ID

GaziosmanpasaTREH20


Responsible Party

Sponsor-Investigator

Study Sponsor

Semra Yuksel


Study Sponsor

sibel bektas, proffessor, Study Chair, Gaziosmanpasa Taksim Education and Research Hospital


Verification Date

May 2020