Kisspeptin Levels in Early Pregnancy

NCT04371991 | Completed

• 1 other identifier: GaziosmanpasaTREH20
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Pregnancy; Ectopic Pregnancy

Keywords

kisspeptin; ectopic pregnancy

Outcome Measures

Primary Outcomes (1)

• Kisspeptin levels in early pregnancy

  Kisspeptin levels can be used for discrimination between ectopic pregnancy and incomplete miscarriage.

  January 2019-January 2020

Study Arms (4)

Group 1

Ectopic pregnancy

Diagnostic Test: blood test

Group 2

Early viable pregnancy

Diagnostic Test: blood test

Group 3

incomplete miscarriage

Diagnostic Test: blood test

Group 4

Healthy women

Diagnostic Test: blood test

Interventions

blood test DIAGNOSTIC_TEST

blood test (serum samples) for biochemical examination

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years - 37 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Women aged between 18-37 years presented with between 5-6 weeks of gestation by last menstrual period.

You may not qualify if:

• 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

Sponsors & Collaborators

• Semra Yuksel: lead

Study Sites (1)

Gaziosmanpasa Taksim Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Kisspeptin is a family of peptide hormones encoded by the KISS1 gene. Kisspeptin acts centrally via the kisspeptin receptor to stimulate the release of gonadotropin-releasing hormone (GnRH) from the hypothalamus and has a critical role in the initiation of puberty. Kisspeptin was first discovered as an inhibitor of tumor metastasis and, as a result, was previously known as metastatin. Kisspeptin is also found in high levels in first-trimester syncytiotrophoblast cells.

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• sibel bektas, proffessor

  Gaziosmanpasa Taksim Education and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator, MD

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: January 5, 2019
• Primary Completion: August 1, 2019
• Study Completion: November 5, 2019
• Last Updated: May 5, 2020

Record last verified: 2020-05

Locations

TU (1)