The Effect of Hydroxytyrosol Administration on Superoxide Dismutase, Pulsatility Index and Resistance Index of Uterine Artery Doppler and Flow-Mediated Dilatation of Brachial Artery In Mothers With Hypertension In Pregnancy: A Randomized Double Blind Controlled Trial
NCT ID: NCT07298759
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
52 participants
INTERVENTIONAL
2025-06-11
2026-02-28
Brief Summary
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Participants will be randomly assigned to receive either hydroxytyrosol or a matching placebo. Both products will be visually identical to ensure blinding. Participants will take two capsules daily for 4 weeks and attend two study visits for assessments and follow-up.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo Group
Participants in this arm will receive a placebo capsule orally twice daily for 4 weeks, alongside standard antenatal care. The placebo is visually identical to the hydroxytyrosol supplement to maintain masking.
Placebo
Placebo oral capsule identical in appearance to hydroxytyrosol supplement, administered twice daily for 4 weeks.
Hydroxytyrosol Group
Participants in this arm will receive hydroxytyrosol 10 mg orally twice daily for 4 weeks, alongside standard antenatal care.
Hydroxytyrosol
Hydroxytyrosol is a natural polyphenol with antioxidant and anti-inflammatory properties, derived from olives. In this study, hydroxytyrosol 10 mg will be administered orally twice daily for 4 weeks to assess its effects on blood pressure and inflammatory biomarkers in hypertensive pregnant women.
Interventions
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Placebo
Placebo oral capsule identical in appearance to hydroxytyrosol supplement, administered twice daily for 4 weeks.
Hydroxytyrosol
Hydroxytyrosol is a natural polyphenol with antioxidant and anti-inflammatory properties, derived from olives. In this study, hydroxytyrosol 10 mg will be administered orally twice daily for 4 weeks to assess its effects on blood pressure and inflammatory biomarkers in hypertensive pregnant women.
Eligibility Criteria
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Inclusion Criteria
2. Gestational age over 24 weeks. Gestational age is confirmed based on:
* Last Menstrual Period (LMP)
* First trimester ultrasound biometry
3. Belongs to the Hypertensive Disorders of Pregnancy group, with the following criteria:
* Gestational hypertension and preeclampsia according to ACOG 2018 criteria
* Chronic hypertension according to ACOG 2019 criteria
* Superimposed preeclampsia according to ACOG 2018 criteria
Exclusion Criteria
2. Pregnancy with other complications (e.g., diabetes mellitus, heart disease, kidney disease, liver disease, malignancy, autoimmune disorders)
3. Refusal to participate in the study
20 Years
35 Years
FEMALE
No
Sponsors
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Dr Cipto Mangunkusumo General Hospital
OTHER
Responsible Party
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Damar Prasmusinto
Consultant Maternal-Fetal Medicine Specialist, Obstetrician-Gynecologist and Principal Investigator
Locations
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Dr. Cipto Mangunkusumo National Central Public Hospital
Jakarta, Jakarta Special Capital Region, Indonesia
Countries
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Facility Contacts
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Intje Sheila Dahlan, dr., Sp.OG
Role: primary
Other Identifiers
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Cipto Mangunkusumo Hospital
Identifier Type: OTHER
Identifier Source: secondary_id
25-03-0305
Identifier Type: -
Identifier Source: org_study_id