Kisspeptin Levels in Early Pregnancy

NCT ID: NCT04371991

Last Updated: 2020-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

88 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-05

Study Completion Date

2019-11-05

Brief Summary

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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

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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.

Conditions

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Early Pregnancy Ectopic Pregnancy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Group 1

Ectopic pregnancy

blood test

Intervention Type DIAGNOSTIC_TEST

blood test (serum samples) for biochemical examination

Group 2

Early viable pregnancy

blood test

Intervention Type DIAGNOSTIC_TEST

blood test (serum samples) for biochemical examination

Group 3

incomplete miscarriage

blood test

Intervention Type DIAGNOSTIC_TEST

blood test (serum samples) for biochemical examination

Group 4

Healthy women

blood test

Intervention Type DIAGNOSTIC_TEST

blood test (serum samples) for biochemical examination

Interventions

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blood test

blood test (serum samples) for biochemical examination

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Semra Yuksel

OTHER_GOV

Sponsor Role lead

Responsible Party

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Semra Yuksel

Principal investigator, MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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sibel bektas, proffessor

Role: STUDY_CHAIR

Gaziosmanpasa Taksim Education and Research Hospital

Locations

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Gaziosmanpasa Taksim Education and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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GaziosmanpasaTREH20

Identifier Type: -

Identifier Source: org_study_id

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