N/A
N=9
Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes
Pre-Eclampsia · Pre-Term · Intrauterine Growth Restriction · Hypertension in Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT04633551 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Blood Pressure (mmHg) — 122; 116 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Anti-inflammatory supplement (Dietary_supplement)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of South Carolina
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Blood Pressure (mmHg) |
122; 116 | — |
| PRIMARY Arterial Stiffness (m/s) |
6.2; 7.8 | — |
| PRIMARY Augmentation Index (%) |
23; 22 | — |
| PRIMARY Endothelial Function (Reactive Hyperemia) |
6.6; 7.6 | — |
| SECONDARY Inflammatory Vascular Biomarkers (pg/dL) |
NA; NA | — |
| SECONDARY Acceptability of Intervention (Likert Scales From 1-5; Not Likely at All to Extremely Likely and Free Text Fields) |
6; 3 | — |
| SECONDARY Perception of Intervention (15-20 Minute Interview) |
5 | — |
Summary
Women who had an adverse pregnancy outcome (APO), such as preeclampsia, preterm birth, or gestational diabetes, have a higher risk for heart disease. Some of the extra risk for heart disease after APOs is thought to be caused by inflammation. Investigators will randomize women who had an APO in the past 3 years to receive an anti-inflammatory supplement or serve as a time control. Investigators will compare blood pressure, arterial stiffness, blood vessel reactivity, and blood markers of inflammation between women who did and did not receive the supplement. Investigators will determine women's attitudes about taking a dietary supplement and measure whether the participants who receive the supplement take all or most of the doses.
Eligibility Criteria
Inclusion Criteria
- Had a singleton pregnancy in the past 3 years that lasted 20 weeks or more
- Most recent pregnancy was complicated by an APO
Exclusion Criteria
- currently pregnant or breastfeeding,
- current smoking,
- active cancer,
- regular use of NSAIDs, steroidal medications, statins, or other anti-inflammatory supplements,
- HIV/AIDS,
- uncontrolled high blood pressure ( >160/>110 mmHg),
- unwilling or unable to use a dietary supplement,
- known sensitivity to resveratrol, curcumin, green tea, or quercetin
Data sourced from ClinicalTrials.gov (NCT04633551). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.