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Does Nicotine Influence the Risk of Preeclampsia?

Does Nicotine Influence the Risk of Preeclampsia? A Prospective Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06645340
Acronym
PRE_Smoking
Enrollment
40
Registered
2024-10-16
Start date
2019-11-02
Completion date
2023-12-17
Last updated
2024-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endothelial Dysfunction, Hypertension in Pregnancy, Preeclampsia (PE)

Keywords

Preeclampsia Risk, Smoking, Endothelial Function, Arterial Stiffness, Retinal Microvasculature

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.

Interventions

OTHERThis high-risk cohort underwent the same measurements during pregnancy: endothelial function, arterial stiffness, retinal microvasculature profile, measurement of Neprilysin, cotinine, telomere length

This high-risk cohort underwent the same measurements during pregnancy: endothelial function, arterial stiffness, retinal microvasculature profile, measurement of Neprilysin, cotinine, telomere length, and routine laboratory parameters.

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Intervention model description

In this prospective cohort study, women at high risk of developing preeclampsia were recruited.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change of Pulse wave velocityMeasurements were conducted at three stages of pregnancy: (V1: 11-16 weeks), second trimester (V2: 24-28 weeks), and third trimester (V3: 34-37 weeks).Pulse Wave Velocity (PWV): A measure of how fast the blood pressure pulse travels through the arteries, used to assess arterial stiffness. Higher PWV indicates stiffer arteries, linked to increased cardiovascular risk.

Secondary

MeasureTime frameDescription
Change of Endothelial functionMeasurements were conducted at three stages of pregnancy: (V1: 11-16 weeks), second trimester (V2: 24-28 weeks), and third trimester (V3: 34-37 weeks).Endothelial Function Assessed through ADMA: Measurement of asymmetric dimethylarginine (ADMA), an inhibitor of nitric oxide production, provides insights into endothelial health and its capacity to regulate vascular function.
Change of retinal microvasculature profileMeasurements were conducted at three stages of pregnancy: (V1: 11-16 weeks), second trimester (V2: 24-28 weeks), and third trimester (V3: 34-37 weeks).Retinal Microvasculature Profile Assessed through CRAE and CRVE: Central retinal arteriolar equivalent (CRAE) and central retinal venular equivalent (CRVE) are used to gauge the caliber of retinal blood vessels, reflecting systemic microvascular health.
Change of Neprilysin levelMeasurements were conducted at three stages of pregnancy: (V1: 11-16 weeks), second trimester (V2: 24-28 weeks), and third trimester (V3: 34-37 weeks).Neprilysin levels are analyzed to understand its role in modulating vasoactive peptides, which affect blood pressure and fluid balance.
Change of Cotinine levelMeasurements were conducted at three stages of pregnancy: (V1: 11-16 weeks), second trimester (V2: 24-28 weeks), and third trimester (V3: 34-37 weeks).Measured to determine exposure to nicotine, providing a reliable indicator of smoking status or secondhand smoke exposure.
Change of Telomere lengthMeasurements were conducted at three stages of pregnancy: (V1: 11-16 weeks), second trimester (V2: 24-28 weeks), and third trimester (V3: 34-37 weeks).Telomere Length: The measurement of telomere length serves as a biomarker of cellular aging and an indicator of potential health risks and longevity.
Blood parameters for high-risk pregnancy monitorMeasurements were conducted at three stages of pregnancy: (V1: 11-16 weeks), second trimester (V2: 24-28 weeks), and third trimester (V3: 34-37 weeks).Blood parameters for high-risk pregnancy monitor kidney, liver, inflammation, blood count, electrolytes, enzymes, coagulation, proteins, and placental function. Kidney: Creatinine, urea, uric acid, eGFR. Liver: Bilirubin, GGT, AST, ALT. Inflammation: CRP. Blood count: Leukocytes, erythrocytes, hemoglobin, hematocrit, MCV, MCH, MCHC, platelets, MPV. Electrolytes: Na, K, Cl, Ca, Mg. Enzymes: CK, LDH, glucose. Coagulation: PT, INR, aPTT, fibrinogen, antithrombin. Proteins: Total protein, albumin. Placental markers: sFlt-1, PlGF. These help assess maternal-fetal health, detect conditions like preeclampsia, gestational diabetes, and monitor complications in high-risk pregnancies.

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026