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CompletedNCT06645340

Does Nicotine Influence the Risk of Preeclampsia?

Does Nicotine Influence the Risk of Preeclampsia? A Prospective Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Medical University of Graz · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2019-11-02
Primary completion
2022-09-30
Completion
2023-12-17
First posted
2024-10-16
Last updated
2024-10-23

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT06645340. Inclusion in this directory is not an endorsement.

Does Nicotine Influence the Risk of Preeclampsia? (NCT06645340) · Clinical Trials Directory