Clinical trial NCT06390202: Uterine Artery Diastolic Notching & Apelin-13 and 36
Official title: Investigation of the Relationship Between Uterine Artery Doppler Diastolic Notching and Serum Apelin-13 and Apelin-36 Concentrations Between the 11th and 14th Weeks of Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnosis
Keywords: uterine artery
apelin-13
apelin-36
Doppler
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-30
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 44 singleton pregnant women with unilateral or bilateral diastolic notching detected in uterine artery Doppler between the 11th and 14th weeks of pregnancy formed the study group (uterine artery notch positive group). 44 singleton pregnant women who did not have diastolic notching in uterine artery Doppler between the 11th and 14th weeks of pregnancy constituted the control group (uterine artery notch negative group).

Brief summary: This study was conducted to investigate the relationship between diastolic notching on uterine artery Doppler and serum apelin-13 and 36 concentrations between 11 and 14 weeks of gestation.

Detailed description: Apelin-13 and apelin-36, which provide vasodilatation through a nitric oxide-dependent mechanism, also play a role in trophoblasts' survival, proliferation, and migration.

Based on this, we aimed to investigate serum apelin-13 and apelin-36 concentrations in pregnant women with and without diastolic notch on uterine artery Doppler between the 11th and 14th weeks of pregnancy.

We hypothesized that apelin-13 and apelin-36 might be associated with the formation of diastolic notch in uterine artery Doppler and serum apelin-13 and apelin-36 concentrations would be lower in the group with a notch in the uterine artery Doppler than in the group without a notch.

Eligibility criteria: Inclusion Criteria:

1. Nonsmokers,
2. Singleton pregnancies between 11 and 14 weeks of gestation
3. Pregnant women who did not conceive with assisted reproductive methods

Exclusion Criteria:

1. Smokers
2. Pregnant women who conceived with assisted reproductive techniques
3. Pregnant women with multiple pregnancies
4. Pregnant women who started with multiples and continued with singletons
5. Pregnant women with any pregestational disease, thrombophilia
6. Pregnant women with any congenital uterine anomaly
7. Pregnant women with a history of recurrent pregnancy loss
8. Pregnant women using aspirin or heparin

Primary outcomes:
measure: Relationship between diastolic notching on uterine artery Doppler and serum apelin-13 and apelin-36 concentrations.
timeFrame: through study completion, an average of 1 year
measure: Relationship between high pulsatility index on uterine artery Doppler and serum apelin-13 and apelin-36 concentrations.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ümraniye Training and Research Hospital
state: Ümraniye
Study officials:
affiliation: Umraniye Education and Research Hospital
name: İbrahim Kale, Associate professor
role: STUDY_DIRECTOR
References: