Vascular Inflammation and Anti-inflammatory Supplements After Adverse Pregnancy Outcomes

NCT04633551 | Completed Results

• 1 other identifier: 10010335
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pre-Eclampsia; Pre-Term; Intrauterine Growth Restriction; Hypertension in Pregnancy

Keywords

adverse pregnancy outcome; inflammation; vascular health

Outcome Measures

Primary Outcomes (4)

• Blood Pressure (mmHg)

  Investigators will measure blood pressure in the arm and use applanation tonometry to estimate aortic blood pressure

  1 month

• Arterial Stiffness (m/s)

  Arterial stiffness will be measured with pulse wave velocity using applanation tonometry and heart rate

  1 month

• Augmentation Index (%)

  Applanation tonometry will be used to describe systolic blood pressure augmentation, a measure of arterial wave reflection intensity.

  1 month

• Endothelial Function (Reactive Hyperemia)

  Venous occlusion plethysmography will be used to mease the change in forearm blood flow after a 5-min occlusion

  1 month

Secondary Outcomes (3)

• Inflammatory Vascular Biomarkers (pg/dL)

  1 month

• Acceptability of Intervention (Likert Scales From 1-5; Not Likely at All to Extremely Likely and Free Text Fields)

  1 month

• Perception of Intervention (15-20 Minute Interview)

  1 month

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in this arm will receive a commercially available anti-inflammatory supplement.

Dietary Supplement: Anti-inflammatory supplement

Control

NO INTERVENTION

Participants in this arm will not receive a commercially available anti-inflammatory supplement.

Interventions

Anti-inflammatory supplement DIETARY_SUPPLEMENT

commercially available combination of curcumin, quercitin, resveratrol, and green tea

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Had a singleton pregnancy in the past 3 years that lasted 20 weeks or more
• Most recent pregnancy was complicated by an APO

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

Public Health Research Center

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia; Premature Birth; Fetal Growth Retardation; Hypertension, Pregnancy-Induced; Inflammation

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Fetal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertension; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

We began the study during the peak of the covid pandemic, and research capacity was limited. Recruitment was low. Target numbers were not reached.

Results Point of Contact

• Title: Abbi Lane-Cordova
• Organization: University of South Carolina

lanecord@mailbox.sc.edu

8037777568

Study Officials

• Abbi Lane-Cordova, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 18, 2020
• Study Start: October 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: May 30, 2022
• Last Updated: September 21, 2023
• Results First Posted: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Upon completion of the study
• Access Criteria: Contact the PI: Abbi Lane-Cordova lanecord@mailbox.sc.edu 803-777-7568

Locations

US (1)