Clinical trial NCT06416995: Serum Vasohibin, Cardiotrophin, Endocan & Perinatal Outcomes
Official title: Investigation of First Trimester Serum Vasohibin-1, Vasohibin-2, Cardiotrophin-1 and Endocan Concentrations in Predicting Adverse Perinatal Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Preeclampsia
Gestational Hypertension
Gestational Diabetes
Preterm Birth
Fetal Growth Retardation
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-05-16
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with a singleton pregnancy who are between 11 and 14 weeks of gestation, who do not smoke, and do not have any systemic disease.

Brief summary: Investigation of the relationship between maternal serum vasohibin-1, vasohibin-2, cardiotrophin -1 and endocan concentrations at the 11th and 14th weeks of gestation and adverse perinatal outcomes.

Detailed description: Previous animal model studies in the literature have shown that vasohibin-1 released in endothelial cells inhibits angiogenesis, while vasohibin-2 stimulates angiogenesis. Additionally, immunohistochemical studies have shown that vasohibin-2 plays a role in the cellular fusion of trophoblasts in the placenta to form syncytiotrophoblasts.

Studies in the literature have shown that cardiotrophin-1 is expressed in cardiac myocytes and vascular endothelial cells and stimulates the synthesis and secretion of endothelin-1 in endothelial cells through the gp130 signaling pathway. Since endothelin 1 plays an important role in the regulation of vascular tone, cardiotrophin-1 can be considered to act as an endothelium-derived biological factor, possibly involved in the regulation of vascular tone under normal physiological conditions or secondary to pathological processes.

Studies in the literature have shown that maternal serum endocan levels are higher in pregnant women whose pregnancies were complicated by preeclampsia than in normotensive pregnant women, and that the endocan molecule may be effective in the etiopathogenesis of preeclampsia, especially if it develops early.

In the light of this above-mentioned information, we aim to investigate whether serum vasohibin-1, vasohibin-2, cardiotrophin-1 and endocan concentrations measured during the 11th to 14th weeks of pregnancy can be used to predict preeclampsia, gestational hypertension, fetal growth restriction, preterm birth and gestational diabetes mellitus.

Eligibility criteria: Inclusion Criteria:

* Those who had the first-trimester screening test between 11 and 14 weeks of pregnancy and are in the low-risk group
* Those with singleton pregnancy
* Those who did not conceive pregnancy with assisted reproductive treatment methods
* Those who do not have any pregestational diseases
* Those who do not have any uterine anomalies

Exclusion Criteria:

* Smokers
* Those who are in the high-risk group with the first trimester screening test
* Those with multiple pregnancies
* Those who conceive with assisted reproductive treatment methods
* Those who had any disease before pregnancy
* Those who have any uterine anomalies

Primary outcomes:
measure: Usability of serum vasohibin-1, vasohibin-2, cardiotropin-1 and endocan concentrations in predicting adverse perinatal outcomes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ümraniye Eğitim ve Araştırma Hastanesi
state: Ümraniye
Study officials:
References: