Kisspeptin Levels in Early Pregnancy

Sponsor

Semra Yuksel (Other)

Overall Status

Completed

CT.gov ID

NCT04371991

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Early Pregnancy Ectopic Pregnancy	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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

88 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Can Kisspeptin be Used for Differential Diagnosis of Early Pregnancies?

Actual Study Start Date :

Jan 5, 2019

Actual Primary Completion Date :

Aug 1, 2019

Actual Study Completion Date :

Nov 5, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 37 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gaziosmanpasa Taksim Education and Research Hospital	Istanbul		Turkey

Sponsors and Collaborators

Semra Yuksel

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Semra Yuksel, Principal investigator, MD, Gaziosmanpasa Research and Education Hospital

ClinicalTrials.gov Identifier:

NCT04371991

Other Study ID Numbers:

GaziosmanpasaTREH20

First Posted:

May 1, 2020

Last Update Posted:

May 5, 2020

Last Verified:

May 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Semra Yuksel, Principal investigator, MD, Gaziosmanpasa Research and Education Hospital

kisspeptin

ectopic pregnancy

Additional relevant MeSH terms:

Pregnancy, Ectopic

Cardiac Complexes, Premature

Study Results

No Results Posted as of May 5, 2020