Does Nicotine Influence the Risk of Preeclampsia?

NCT06645340 | Completed

• 1 other identifier: EK-Nr.: 31-541 ES 18/19
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia (PE); Endothelial Dysfunction; Hypertension in Pregnancy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change of Pulse wave velocity

  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.

  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 (6)

• Change of Endothelial function

  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).

• Change of retinal microvasculature profile

  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).

• Change of Neprilysin level

  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).

• Change of Cotinine level

  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).

• Change of Telomere length

  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).

Study Arms (2)

previous smokers

OTHER

All women at high risk for developing preeclampsia were divided into two groups based on reported smoking status: previous smokers who quit by the positive pregnancy test, and non-smokers.

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

non smokers

OTHER

All women at high risk for developing preeclampsia were divided into two groups based on reported smoking status: previous smokers who quit by the positive pregnancy test, and non-smokers.

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

Interventions

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

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.

non smokers; previous smokers

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only pregnant women at high risk for preeclampsia
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University Graz

Graz, Styria, 8036, Austria

Location

MeSH Terms

Conditions

Pre-Eclampsia; Hypertension, Pregnancy-Induced; Smoking

Interventions

Vascular Stiffness; Cotinine

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 16, 2024
• Study Start: November 2, 2019
• Primary Completion: September 30, 2022
• Study Completion: December 17, 2023
• Last Updated: October 23, 2024

Record last verified: 2024-10

Locations

AU (1)