Clinical trial NCT06645340: Does Nicotine Influence the Risk of Preeclampsia?
Official title: Does Nicotine Influence the Risk of Preeclampsia? A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preeclampsia (PE)
Endothelial Dysfunction
Hypertension in Pregnancy
Keywords: Preeclampsia Risk
Smoking
Endothelial Function
Arterial Stiffness
Retinal Microvasculature
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: In this prospective cohort study, women at high risk of developing preeclampsia were recruited.
Primary purpose: SCREENING

Brief summary: This prospective cohort study explores the long-term impact of pre-pregnancy smoking on vascular health in women predisposed to preeclampsia, conducted at the Medical University of Graz. The study specifically targets women at high risk for preeclampsia who are taking aspirin as a preventative measure.

The main question it aims to answer is:

Does smoking before pregnancy influence the development and severity of preeclampsia and its associated vascular changes in high-risk women?

Participants, divided into former smokers and non-smokers, underwent comprehensive assessments throughout their pregnancies. Measurements included hemodynamic parameters such as heart rate and blood pressure, assessed with an upper arm cuff, and arterial stiffness, evaluated using pulse wave velocity with the Vicorder device. Retinal microvasculature was examined through digital imaging, and the vascular health marker ADMA, nicotine exposure marker cotinine, blood pressure regulatory enzyme neprilysin, and cellular aging indicator telomere length were quantified from blood samples. Cortisol levels were also measured from hair samples to assess stress responses.

Detailed description: The investigators collected extensive data on each participant, including age, BMI (body mass index), and medical history, to understand their baseline health. Routine laboratory tests were conducted to monitor the health status throughout the pregnancy. Preeclampsia biomarkers and Doppler ultrasound examinations of the uterine and umbilical arteries to assess fetal and placental blood flow were conducted. The investigators tracked the development of preeclampsia, gestational hypertension (GH), and gestational diabetes mellitus (GDM).

Outcomes for the babies, such as birth weight, delivery method, gender, and the gestational week at delivery, were meticulously recorded to evaluate the broader impacts of maternal smoking and vascular health on neonatal outcomes.

Eligibility criteria: Inclusion Criteria:

* a positive preeclampsia screening or a history of preeclampsia, daily intake of 150mg aspirin , and age over 18 years

Exclusion Criteria:

* twin pregnancies, fetal anomalies, maternal chronic renal diseases and discontinued aspirin intake.

Primary outcomes:
measure: Change of Pulse wave velocity
timeFrame: Measurements were conducted at three stages of pregnancy: (V1: 11-16 weeks), second trimester (V2: 24-28 weeks), and third trimester (V3: 34-37 weeks).
Secondary outcomes:
measure: Change of Endothelial function
timeFrame: Measurements were conducted at three stages of pregnancy: (V1: 11-16 weeks), second trimester (V2: 24-28 weeks), and third trimester (V3: 34-37 weeks).
measure: Change of retinal microvasculature profile
timeFrame: Measurements were conducted at three stages of pregnancy: (V1: 11-16 weeks), second trimester (V2: 24-28 weeks), and third trimester (V3: 34-37 weeks).
measure: Change of Neprilysin level
timeFrame: Measurements were conducted at three stages of pregnancy: (V1: 11-16 weeks), second trimester (V2: 24-28 weeks), and third trimester (V3: 34-37 weeks).
measure: Change of Cotinine level
timeFrame: Measurements were conducted at three stages of pregnancy: (V1: 11-16 weeks), second trimester (V2: 24-28 weeks), and third trimester (V3: 34-37 weeks).
measure: Change of Telomere length
timeFrame: Measurements were conducted at three stages of pregnancy: (V1: 11-16 weeks), second trimester (V2: 24-28 weeks), and third trimester (V3: 34-37 weeks).
measure: Blood parameters for high-risk pregnancy monitor
timeFrame: Measurements were conducted at three stages of pregnancy: (V1: 11-16 weeks), second trimester (V2: 24-28 weeks), and third trimester (V3: 34-37 weeks).
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
state: Steiermark
Study officials:
References: