Preeclampsia SeverePhase 4preGONCT07361679

LDA and LMWH vs LDA Alone in High-risk Patients for Preeclampsia Prevention

A Phase 4 study testing Aspirin and Tinzaparin in people with Preeclampsia Severe and Toxemia Of Pregnancy, run by Alexandra Hospital, Athens, Greece at 1 site in Greece.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Preeclampsia Severe, Toxemia Of Pregnancy, Preeclampsia
What is being tested?: Aspirin and Tinzaparin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteGreece
Study dates: 18 Jan 2023to 1 Jul 2027
Phase: Phase 4
Are there results?: Not yet: the study is under way

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

Singleton pregnancy
High risk for preeclampsia (risk >1:150) based on FMF screening algorithm combining first-trimester ultrasound, biochemical markers, and medical history
Gestational age <16 weeks at enrollment
Maternal age ≥18 years
Willing and able to provide written informed consent
Adequate ability for follow-up (direct telephone communication, accessible residence)

Who cannot join

Multiple pregnancy
Current permanent aspirin use for other medical indications
Serious congenital fetal abnormality detected on ultrasound
Contraindication to aspirin or low molecular weight heparin including: known hypersensitivity, active peptic ulcer disease, bleeding disorders or coagulopathy, severe thrombocytopenia (platelet count <100,000/μL), active or recent significant bleeding, history of heparin-induced thrombocytopenia
Pre-existing severe renal failure (creatinine clearance <30 mL/min)
Unable to provide informed consent
Low probability of adequate follow-up (residence in remote areas without telephone access, accommodation in temporary structures)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dimitrios Baroutis, MD, MSc, PhD(c) contact

+306978275745

dbaroutis@gmail.com

Greece1 site, 1 recruiting

First Department of Obstetrics and Gynecology, Alexandra Hospital
Athens, Attica, 11528
Dimitrios Baroutis, MD, MSc, PhD(c), +30 6978275745, dbaroutis@gmail.com
Georgios Daskalakis, MD, PhD, +30 6945235757, gdaskalakis@yahoo.com
Recruiting

Other trials in Greece

About this study

Official title: Combined Administration of Low Molecular Weight Heparin and Aspirin Versus Aspirin Alone in Gravidas at High Risk for Preeclampsia: A Randomized Controlled Trial

Preeclampsia is a major cause of maternal and perinatal morbidity and mortality worldwide. Low-dose aspirin started in the first trimester reduces the risk of preeclampsia in high-risk women. Low molecular weight heparin (LMWH) has shown potential benefits in addition to aspirin for preventing preeclampsia through its anticoagulant, anti-inflammatory, and endothelial protective effects. However, current evidence is limited and conflicting regarding the added value of LMWH to aspirin. This randomized controlled trial aims to evaluate the efficacy of combined aspirin and LMWH, compared to aspirin alone, for reducing the incidence of preeclampsia in high-risk gravidas.

Read the detailed description

This is a prospective, randomized, single-center, open-label trial conducted at the First Obstetrics and Gynecology Clinic of Alexandra Hospital, Athens, Greece. One hundred pregnant women at high risk of preeclampsia (risk >1:150) will be randomly allocated 1:1 to receive either 160mg aspirin daily (n=50) or 160mg aspirin plus weight-adjusted therapeutic doses of LMWH (tinzaparin 4,500-8,000 IU daily based on weight) (n=50) initiated before 16 weeks gestation until 36 weeks.

Risk assessment will be performed using the internationally recognized FMF (Fetal Medicine Foundation) model, combining first trimester ultrasound examination, biochemical markers, and individual medical history.

The primary outcome is the incidence of preeclampsia. Secondary outcomes include development of early preeclampsia (<34 weeks), gestational hypertension, HELLP syndrome, spontaneous preterm labor, intrauterine growth restriction, placental abruption, and various neonatal outcomes.

Blood samples will be collected at 20-24, 32-34, and 36 weeks to measure biomarkers including PlGF, sFlt-1, E-Selectin, IL-1β, IL-6, IL-10, TNF-α, sFlt-1/PlGF ratio, and systemic immune-inflammation index (SII). Regular telephone follow-up will be conducted to monitor adherence and adverse events.

Conditions: Preeclampsia Severe, Toxemia Of Pregnancy, Preeclampsia, Pregnancy Complications, Hypertension, Pregnancy-Induced, Gestational Hypertension
Being tested: Aspirin, Tinzaparin
Keywords: preeclampsia, gestational hypertension, toxemia, Preeclampsia prevention, Low molecular weight heparin, tinzaparin, High-risk pregnancy, LMWH, Maternal-fetal medicine
Medical subject headings: Pre-Eclampsia, Pregnancy Complications, Hypertension, Pregnancy-Induced, Toxemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AspirinDrug
Also called ASA, Low-dose aspirin, Acetylsalicylic acid
Aspirin 160 mg orally once daily before bedtime. Duration: From enrollment (<16 weeks gestation) until 36 weeks gestation.
TinzaparinDrug
Also called Low molecular weight heparin, Innohep, LMWH
Weight-adjusted tinzaparin administered subcutaneously once daily in the morning: 4,500 Anti-Xa IU/day for weight ≤60 kg, 6,000 Anti-Xa IU/day for weight 60-90 kg, and 8,000 Anti-Xa IU/day for weight >90 kg. Duration: From enrollment (<16 weeks gestation) until 36 weeks gestation.

Study groups in NCT07361679
Study group	Role	What they receive
Aspirin Alone	Active comparator	Participants receive aspirin 160 mg orally once daily before bedtime from enrollment (<16 weeks gestation) until 36 weeks gestation. Receives: Drug: Aspirin
Aspirin plus LMWH	Experimental	Participants receive aspirin 160 mg orally once daily before bedtime PLUS weight-adjusted tinzaparin subcutaneously once daily in the morning (4,500 Anti-Xa IU for weight ≤60 kg, 6,000 Anti-Xa IU for weight 60-90 kg, 8,000 Anti-Xa IU for weight >90 kg) from enrollment (<16 weeks gestation) until 36 weeks gestation. Receives: Drug: Aspirin; Drug: Tinzaparin

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Preeclampsia
Preeclampsia defined as gestational hypertension (BP ≥140/90 mmHg on at least two measurements ≥4 hours apart) after 20 weeks' gestation accompanied by one or more of: (1) Proteinuria (≥30 mg/mmol protein:creatinine ratio, ≥8 mg/mmol albumin:creatinine ratio, ≥0.3 g/24h, or ≥2+ dipstick); (2) Maternal end-organ dysfunction including neurological complications (severe headaches, visual scotomata, eclampsia, stroke, clonus), pulmonary oedema, haematological complications (platelet count <150,000/μL, disseminated intravascular coagulation, haemolysis), acute kidney injury (creatinine ≥90 μmol/L or 1 mg/dL), or liver involvement (elevated ALT or AST >40 IU/L); or (3) Uteroplacental dysfunction (fetal growth restriction, abnormal umbilical artery Doppler waveform analysis, placental abruption, angiogenic imbalance, or intrauterine fetal death), per ISSHP 2021 classification.
Measured: From enrollment until delivery (up to 40 weeks gestation)

Secondary outcomes (14)

Systemic Immune-Inflammation Index (SII)
Systemic immune-inflammation index calculated as SII = P × N/L, where P, N, and L are the peripheral blood platelet count, neutrophil count, and lymphocyte count respectively (cells per liter)
Measured: At 20-24 weeks, 32-34 weeks, and 36 weeks gestation
Incidence of Preterm Preeclampsia
Development of preeclampsia before 37 weeks gestation
Measured: From enrollment until 37 weeks gestation
Prevalence of placental histopathological lesions
Histopathological examination of placental tissue including assessment of maternal vascular malperfusion, fetal vascular malperfusion, villous lesions, inflammatory lesions, and other pathological findings according to standardized criteria
Measured: At delivery
Soluble fms-like Tyrosine Kinase-1 (sFlt-1) Levels
Serum levels of soluble fms-like tyrosine kinase-1 (sFlt-1) measured by immunoassay
Measured: At 20-24 weeks, 32-34 weeks, and 36 weeks gestation
Placental Growth Factor (PlGF) Levels
Serum levels of placental growth factor (PlGF) measured by immunoassay
Measured: At 20-24 weeks, 32-34 weeks, and 36 weeks gestation
sFlt-1/PlGF Ratio
Ratio of soluble fms-like tyrosine kinase-1 to placental growth factor (sFlt-1/PlGF ratio) measured by immunoassay
Measured: At 20-24 weeks, 32-34 weeks, and 36 weeks gestation
Interleukin-6 (IL-6) Levels
Serum levels of interleukin-6 (IL-6) measured by immunoassay
Measured: At 20-24 weeks, 32-34 weeks, and 36 weeks gestation
Incidence of Early-Onset Preeclampsia
Development of preeclampsia before 34 weeks gestation (early-onset preeclampsia)
Measured: From enrollment until 34 weeks gestation
Incidence of Gestational Hypertension
New-onset hypertension (blood pressure ≥140/90 mmHg on two occasions at least 4 hours apart) after 20 weeks gestation without proteinuria or evidence of end-organ dysfunction
Measured: From 20 weeks gestation until delivery (up to 40 weeks)
Rate of Spontaneous Preterm Birth
Spontaneous preterm labor resulting in delivery before 34 weeks gestation and before 37 weeks gestation
Measured: From enrollment until delivery, assessed up to 40 weeks gestation
Incidence of Small for Gestational Age
Birth weight below the 3rd, 5th, and 10th percentile for gestational age based on standardized fetal growth charts (small for gestational age)
Measured: At delivery
Perinatal Death
Miscarriage, intrauterine fetal death, or neonatal death within 28 days after birth attributed to preeclampsia or fetal growth restriction
Measured: From enrollment until 28 days after delivery
Neonatal Complications and Therapy
Composite of neonatal adverse outcomes including sepsis, intraventricular hemorrhage grade III-IV, necrotizing enterocolitis, respiratory distress syndrome (RDS), need for surfactant therapy, mechanical ventilation, blood transfusion, and admission to neonatal intensive care unit (NICU) with duration of stay
Measured: From delivery until hospital discharge (up to 3 months)
Placental Abruption
Premature separation of the placenta from the uterine wall before delivery
Measured: From enrollment until delivery (up to 40 weeks gestation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jan 20231 Jul 2027

First posted23 Jan 2026
Study start18 Jan 2023
Primary completion1 Aug 2026 (estimated)
Study completion1 Jul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Preeclampsia SevereStudies of the same condition, open and under way.
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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Two parallel groups: Arm 1 receives aspirin alone, Arm 2 receives aspirin plus weight-adjusted LMWH
Masking: None (open label)
Enrolment: 100 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07361679
Sponsor's protocol ID: 724/23-11-2022
Acronym: preGO
Status last verified: Jan 2026
First submitted: 21 Dec 2025
Last updated: 23 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: The decision on individual participant data sharing will be made in accordance with institutional policies and ethical requirements. The data sharing plan will be finalized prior to study completion and publication of results.

Publications

McLaughlin K, Baczyk D, Potts A, Hladunewich M, Parker JD, Kingdom JC. Low Molecular Weight Heparin Improves Endothelial Function in Pregnant Women at High Risk of Preeclampsia. Hypertension. 2017 Jan;69(1):180-188. doi: 10.1161/HYPERTENSIONAHA.116.08298. Epub 2016 Nov 13.
PubMed 27840330
Cruz-Lemini M, Vazquez JC, Ullmo J, Llurba E. Low-molecular-weight heparin for prevention of preeclampsia and other placenta-mediated complications: a systematic review and meta-analysis. Am J Obstet Gynecol. 2022 Feb;226(2S):S1126-S1144.e17. doi: 10.1016/j.ajog.2020.11.006. Epub 2021 Apr 20.
PubMed 34301348
Wright D, Wright A, Nicolaides KH. The competing risk approach for prediction of preeclampsia. Am J Obstet Gynecol. 2020 Jul;223(1):12-23.e7. doi: 10.1016/j.ajog.2019.11.1247. Epub 2019 Nov 13.
PubMed 31733203
Magee LA, Brown MA, Hall DR, Gupte S, Hennessy A, Karumanchi SA, Kenny LC, McCarthy F, Myers J, Poon LC, Rana S, Saito S, Staff AC, Tsigas E, von Dadelszen P. The 2021 International Society for the Study of Hypertension in Pregnancy classification, diagnosis & management recommendations for international practice. Pregnancy Hypertens. 2022 Mar;27:148-169. doi: 10.1016/j.preghy.2021.09.008. Epub 2021 Oct 9.
PubMed 35066406
Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.
PubMed 28657417
Magee LA, Nicolaides KH, von Dadelszen P. Preeclampsia. N Engl J Med. 2022 May 12;386(19):1817-1832. doi: 10.1056/NEJMra2109523. No abstract available.
PubMed 35544388

Interested in taking part?

Dimitrios Baroutis, MD, MSc, PhD(c)

+306978275745

dbaroutis@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Preeclampsia Severe trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Combined Administration of Low Molecular Weight Heparin and Aspirin Versus Aspirin Alone in Gravidas at High Risk for Preeclampsia: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07361679
Acronym / sponsor ID: preGO / 724/23-11-2022
Conditions: Preeclampsia Severe, Toxemia Of Pregnancy, Preeclampsia, Pregnancy Complications, Hypertension, Pregnancy-Induced, Gestational Hypertension
Keywords: preeclampsia, gestational hypertension, toxemia, Preeclampsia prevention, Low molecular weight heparin, tinzaparin, High-risk pregnancy, LMWH
Phase: Phase 4
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 100 participants (estimated)
Lead sponsor: Alexandra Hospital, Athens, GreeceUniversity, hospital or other
Study start: 18 Jan 2023 (actual)
Primary completion: 1 Aug 2026 (estimated)
Study completion: 1 Jul 2027 (estimated)
First posted: 23 Jan 2026 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Two parallel groups: Arm 1 receives aspirin alone, Arm 2 receives aspirin plus weight-adjusted LMWH

Arm	Type	Receives
Aspirin Alone	Active comparator	Drug: AspirinParticipants receive aspirin 160 mg orally once daily before bedtime from enrollment (<16 weeks gestation) until 36 weeks gestation.
Aspirin plus LMWH	Experimental	Drug: Aspirin, Drug: TinzaparinParticipants receive aspirin 160 mg orally once daily before bedtime PLUS weight-adjusted tinzaparin subcutaneously once daily in the morning (4,500 Anti-Xa IU for weight ≤60 kg, 6,000 Anti-Xa IU for weight 60-90 kg, 8,000 Anti-Xa IU for weight >90 kg) from enrollment (<16 weeks gestation) until 36 weeks gestation.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Singleton pregnancy
High risk for preeclampsia (risk >1:150) based on FMF screening algorithm combining first-trimester ultrasound, biochemical markers, and medical history
Gestational age <16 weeks at enrollment
Maternal age ≥18 years
Willing and able to provide written informed consent

Key exclusion criteria (7 listed)

Multiple pregnancy
Current permanent aspirin use for other medical indications
Serious congenital fetal abnormality detected on ultrasound
Contraindication to aspirin or low molecular weight heparin including: known hypersensitivity, active peptic ulcer disease, bleeding disorders or coagulopathy, severe thrombocytopenia (platelet count <100,000/μL), active or recent significant bleeding, history of heparin-induced thrombocytopenia
Pre-existing severe renal failure (creatinine clearance <30 mL/min)

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
AspirinAlso: ASA, Low-dose aspirin, Acetylsalicylic acidAspirin 160 mg orally once daily before bedtime. Duration: From enrollment (<16 weeks gestation) until 36 weeks gestation.	Drug	Aspirin Alone, Aspirin plus LMWH
TinzaparinAlso: Low molecular weight heparin, Innohep, LMWHWeight-adjusted tinzaparin administered subcutaneously once daily in the morning: 4,500 Anti-Xa IU/day for weight ≤60 kg, 6,000 Anti-Xa IU/day for weight 60-90 kg, and 8,000 Anti-Xa IU/day for weight >90 kg. Duration: From enrollment (<16 weeks gestation) until 36 weeks gestation.	Drug	Aspirin plus LMWH

Primary outcome

Incidence of Preeclampsia
Time frame: From enrollment until delivery (up to 40 weeks gestation)
Preeclampsia defined as gestational hypertension (BP ≥140/90 mmHg on at least two measurements ≥4 hours apart) after 20 weeks' gestation accompanied by one or more of: (1) Proteinuria (≥30 mg/mmol protein:creatinine ratio, ≥8 mg/mmol albumin:creatinine ratio, ≥0.3 g/24h, or ≥2+ dipstick); (2) Maternal end-organ dysfunction including neurological complications (severe headaches, visual scotomata, eclampsia, stroke, clonus), pulmonary oedema, haematological complications (platelet count <150,000/μL, disseminated intravascular coagulation, haemolysis), acute kidney injury (creatinine ≥90 μmol/L or 1 mg/dL), or liver involvement (elevated ALT or AST >40 IU/L); or (3) Uteroplacental dysfunction (fetal growth restriction, abnormal umbilical artery Doppler waveform analysis, placental abruption, angiogenic imbalance, or intrauterine fetal death), per ISSHP 2021 classification.

14 secondary outcomes

Systemic Immune-Inflammation Index (SII)
Time frame: At 20-24 weeks, 32-34 weeks, and 36 weeks gestation
Incidence of Preterm Preeclampsia
Time frame: From enrollment until 37 weeks gestation
Prevalence of placental histopathological lesions
Time frame: At delivery
Soluble fms-like Tyrosine Kinase-1 (sFlt-1) Levels
Time frame: At 20-24 weeks, 32-34 weeks, and 36 weeks gestation
Placental Growth Factor (PlGF) Levels
Time frame: At 20-24 weeks, 32-34 weeks, and 36 weeks gestation
sFlt-1/PlGF Ratio
Time frame: At 20-24 weeks, 32-34 weeks, and 36 weeks gestation
Interleukin-6 (IL-6) Levels
Time frame: At 20-24 weeks, 32-34 weeks, and 36 weeks gestation
Incidence of Early-Onset Preeclampsia
Time frame: From enrollment until 34 weeks gestation
Incidence of Gestational Hypertension
Time frame: From 20 weeks gestation until delivery (up to 40 weeks)
Rate of Spontaneous Preterm Birth
Time frame: From enrollment until delivery, assessed up to 40 weeks gestation
Incidence of Small for Gestational Age
Time frame: At delivery
Perinatal Death
Time frame: From enrollment until 28 days after delivery
Neonatal Complications and Therapy
Time frame: From delivery until hospital discharge (up to 3 months)
Placental Abruption
Time frame: From enrollment until delivery (up to 40 weeks gestation)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
Background: PubMed 27840330McLaughlin K, Baczyk D, Potts A, Hladunewich M, Parker JD, Kingdom JC. Low Molecular Weight Heparin Improves Endothelial Function in Pregnant Women at High Risk of Preeclampsia. Hypertension. 2017 Jan;69(1):180-188. doi: 10.1161/HYPERTENSIONAHA.116.08298. Epub 2016 Nov 13.
Background: PubMed 34301348Cruz-Lemini M, Vazquez JC, Ullmo J, Llurba E. Low-molecular-weight heparin for prevention of preeclampsia and other placenta-mediated complications: a systematic review and meta-analysis. Am J Obstet Gynecol. 2022 Feb;226(2S):S1126-S1144.e17. doi: 10.1016/j.ajog.2020.11.006. Epub 2021 Apr 20.
Background: PubMed 31733203Wright D, Wright A, Nicolaides KH. The competing risk approach for prediction of preeclampsia. Am J Obstet Gynecol. 2020 Jul;223(1):12-23.e7. doi: 10.1016/j.ajog.2019.11.1247. Epub 2019 Nov 13.
Background: PubMed 35066406Magee LA, Brown MA, Hall DR, Gupte S, Hennessy A, Karumanchi SA, Kenny LC, McCarthy F, Myers J, Poon LC, Rana S, Saito S, Staff AC, Tsigas E, von Dadelszen P. The 2021 International Society for the Study of Hypertension in Pregnancy classification, diagnosis & management recommendations for international practice. Pregnancy Hypertens. 2022 Mar;27:148-169. doi: 10.1016/j.preghy.2021.09.008. Epub 2021 Oct 9.
Background: PubMed 28657417Rolnik DL, Wright D, Poon LC, O'Gorman N, Syngelaki A, de Paco Matallana C, Akolekar R, Cicero S, Janga D, Singh M, Molina FS, Persico N, Jani JC, Plasencia W, Papaioannou G, Tenenbaum-Gavish K, Meiri H, Gizurarson S, Maclagan K, Nicolaides KH. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. N Engl J Med. 2017 Aug 17;377(7):613-622. doi: 10.1056/NEJMoa1704559. Epub 2017 Jun 28.
Background: PubMed 35544388Magee LA, Nicolaides KH, von Dadelszen P. Preeclampsia. N Engl J Med. 2022 May 12;386(19):1817-1832. doi: 10.1056/NEJMra2109523. No abstract available.
Individual participant dataSharing planned: Undecided. The decision on individual participant data sharing will be made in accordance with institutional policies and ethical requirements. The data sharing plan will be finalized prior to study completion and publication of results.

Related trials for Preeclampsia Severe

Not yet recruitingPhase 2
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Severe Preeclampsia
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Not yet recruitingPhase 4
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Not yet recruitingObservational study
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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.

Dimitrios Baroutis, MD, MSc, PhD(c) contact

+306978275745

dbaroutis@gmail.com

Georgios Daskalakis, PhD study chair

First Department of Obstetrics and Gynecology, Alexandra Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aspirin and Tinzaparin in people with Preeclampsia Severe and Toxemia Of Pregnancy, run by Alexandra Hospital, Athens, Greece at 1 site in Greece.

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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. 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 Greece. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dimitrios Baroutis, MD, MSc, PhD(c) (+306978275745, dbaroutis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Preeclampsia (time frame: From enrollment until delivery (up to 40 weeks gestation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07361679, which also lists 6 linked publications.

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 Jan 2026.