Kisspeptin Levels in Early Pregnancy

Completed

• Conditions: Early Pregnancy; Ectopic Pregnancy
• Interventions: Diagnostic Test: blood test

• Registration Number: NCT04371991
• Lead Sponsor: Semra Yuksel

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 Timeline

• Study Start: 2019-01-05
• Primary Completion: 2019-08-01
• Study Completion: 2019-11-05
• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-04-29
• Status Verified: 2020-05
• Study First Posted: 2020-05-01
• Last Update Submitted: 2020-05-01
• Last Update Posted: 2020-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 88

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	blood test	Early viable pregnancy
Group 1	blood test	Ectopic pregnancy
Group 3	blood test	incomplete miscarriage
Group 4	blood test	Healthy women

Primary Outcome Measures

Name	Time	Method
Kisspeptin levels in early pregnancy	January 2019-January 2020	Kisspeptin levels can be used for discrimination between ectopic pregnancy and incomplete miscarriage.

Trial Locations

Locations (1)

Gaziosmanpasa Taksim Education and Research Hospital; 🇹🇷 Istanbul, Turkey