Kisspeptin Levels in Early Pregnancy

Can Kisspeptin be Used for Differential Diagnosis of Early Pregnancies?

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.

Study Overview

• Status: Completed
• Conditions: Ectopic Pregnancy; Early Pregnancy
• Intervention / Treatment: Diagnostic test: blood test

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
• Enrollment (Actual): 88

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Gaziosmanpasa Taksim Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 37 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women were considered for the study if they presented between 5-6 weeks of gestation by last menstrual period. Patients were included if they had either confirmed intrauterine pregnancy (IUP) by ultrasound (n=22) or confirmed miscarriage (SAB) by ultrasound (n=20) or ectopic pregnancy.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Ectopic pregnancy	Diagnostic test: blood test; blood test (serum samples) for biochemical examination
Group 2; Early viable pregnancy	Diagnostic test: blood test; blood test (serum samples) for biochemical examination
Group 3; incomplete miscarriage	Diagnostic test: blood test; blood test (serum samples) for biochemical examination
Group 4; Healthy women	Diagnostic test: blood test; blood test (serum samples) for biochemical examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kisspeptin levels in early pregnancy	Kisspeptin levels can be used for discrimination between ectopic pregnancy and incomplete miscarriage.	January 2019-January 2020

Collaborators and Investigators

• Sponsor: Semra Yuksel
• Investigators: Study Chair: sibel bektas, proffessor, Gaziosmanpasa Taksim Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2019
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): November 5, 2019

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 1, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: ectopic pregnancy; kisspeptin
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Pregnancy, Ectopic; Cardiac Complexes, Premature
• Other Study ID Numbers: GaziosmanpasaTREH20

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No