Preeclampsia (PE)PRE_SmokingNCT06645340
Does Nicotine Influence the Risk of Preeclampsia?
A study testing This high-risk cohort underwent the same measurements during pregnancy: endothelial function, arterial stiffness, retinal microvasculature profile, measurement of Neprilysin, cotinine, telomere length in people with Preeclampsia (PE) and Endothelial Dysfunction, run by Medical University of Graz at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia (PE), Endothelial Dysfunction, Hypertension in Pregnancy
- What is being tested?
- This high-risk cohort underwent the same measurements during pregnancy: endothelial function, arterial stiffness, retinal microvasculature profile, measurement of Neprilysin, cotinine, telomere length
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 2 Nov 2019to 17 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a positive preeclampsia screening or a history of preeclampsia, daily intake of 150mg aspirin , and age over 18 years
Who cannot join
- twin pregnancies, fetal anomalies, maternal chronic renal diseases and discontinued aspirin intake.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Nicotine Influence the Risk of Preeclampsia? A Prospective Study
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:
Read more
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.
Read the 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.
- Being tested
- This high-risk cohort underwent the same measurements during pregnancy: endothelial function, arterial stiffness, retinal microvasculature profile, measurement of Neprilysin, cotinine, telomere length
- Keywords
- Preeclampsia Risk, Smoking, Endothelial Function, Arterial Stiffness, Retinal Microvasculature
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This high-risk cohort underwent the same measurements during pregnancy: endothelial function, arterial stiffness, retinal microvasculature profile, measurement of Neprilysin, cotinine, telomere lengthOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: This high-risk cohort underwent the same measurements during pregnancy: endothelial function, arterial stiffness, retinal microvasculature profile, measurement of Neprilysin, cotinine, telomere length |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Neprilysin levels are analyzed to understand its role in modulating vasoactive peptides, which affect blood pressure and fluid balance.
Measured: 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
Measured to determine exposure to nicotine, providing a reliable indicator of smoking status or secondhand smoke exposure.
Measured: 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
Telomere Length: The measurement of telomere length serves as a biomarker of cellular aging and an indicator of potential health risks and longevity.
Measured: 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).
Blood parameters for high-risk pregnancy monitor
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start2 Nov 2019
- Primary completion30 Sep 2022
- Study completion17 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia (PE)Studies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- In this prospective cohort study, women at high risk of developing preeclampsia were recruited.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645340
- Sponsor's protocol ID
- EK-Nr.: 31-541 ES 18/19
- Acronym
- PRE_Smoking
- Status last verified
- Oct 2024
- First submitted
- 15 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Nicotine Influence the Risk of Preeclampsia? A Prospective Study
- ClinicalTrials.gov ID
- NCT06645340
- Acronym / sponsor ID
- PRE_Smoking / EK-Nr.: 31-541 ES 18/19
- Keywords
- Preeclampsia Risk, Smoking, Endothelial Function, Arterial Stiffness, Retinal Microvasculature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 2 Nov 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 17 Dec 2023 (actual)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In this prospective cohort study, women at high risk of developing preeclampsia were recruited.
| Arm | Type | Receives |
|---|---|---|
| previous smokers | Other | Other: This high-risk cohort underwent the same measurements during pregnancy: endothelial function, arterial stiffness, retinal microvasculature profile, measurement of Neprilysin, cotinine, telomere lengthAll 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. |
| non smokers | Other | Other: This high-risk cohort underwent the same measurements during pregnancy: endothelial function, arterial stiffness, retinal microvasculature profile, measurement of Neprilysin, cotinine, telomere lengthAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- a positive preeclampsia screening or a history of preeclampsia, daily intake of 150mg aspirin , and age over 18 years
Key exclusion criteria (1 listed)
- twin pregnancies, fetal anomalies, maternal chronic renal diseases and discontinued aspirin intake.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This 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. | Other | non smokers, previous smokers |
Primary outcome
Change of Pulse wave velocity
Time frame: 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).
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.
6 secondary outcomes
Change of Endothelial function
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Blood parameters for high-risk pregnancy monitor
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing This high-risk cohort underwent the same measurements during pregnancy: endothelial function, arterial stiffness, retinal microvasculature profile, measurement of Neprilysin, cotinine, telomere length in people with Preeclampsia (PE) and Endothelial Dysfunction, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Pulse wave velocity (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2024.