Kisspeptin Levels in Early Pregnancy

Ectopic Pregnancy Clinical Trial

Official title:

Can Kisspeptin be Used for Differential Diagnosis of Early Pregnancies?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04371991
• Other study ID #: GaziosmanpasaTREH20
• Status: Completed
• Start date: January 5, 2019
• Est. completion date: November 5, 2019

Study information

• Verified date: May 2020
• Source: Gaziosmanpasa Taksim Research and Education Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: November 5, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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

Related Conditions & MeSH terms

• Early Pregnancy
• Ectopic Pregnancy
• Pregnancy, Ectopic

Intervention

Diagnostic Test:
• blood test
blood test (serum samples) for biochemical examination

Locations

Country	Name	City	State
Turkey	Gaziosmanpasa Taksim Education and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Semra Yuksel

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kisspeptin levels in early pregnancy	Kisspeptin levels can be used for discrimination between ectopic pregnancy and incomplete miscarriage.	January 2019-January 2020