Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05653973
Other study ID # 202203433
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date January 3, 2023
Est. completion date April 30, 2025

Study information

Verified date May 2024
Source University of Iowa
Contact Anna Reid-Stanhewicz, PHD
Phone 319-467-1732
Email anna-stanhewicz@uiowa.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Preeclampsia is a pregnancy disorder affecting ~5-10% of pregnancies in the United States. Women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life, even if they are otherwise healthy. The reason why this occurs is unclear but may be related to blood vessel damage and increased inflammation that occurs during the preeclamptic pregnancy and persists postpartum. Low dose aspirin (LDA; 75-150mg/daily) is currently the most effective and clinically accepted therapy for reducing preeclampsia prevalence in women at high risk for developing the syndrome. The purpose of this study is to interrogate the mechanisms by which LDA therapy mitigates persistent vascular dysfunction in postpartum women who have had preeclampsia. In this study, the investigators use the blood vessels in the skin as a representative vascular bed for examining mechanisms of microvascular dysfunction in humans. Using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) they examine the blood vessels in a dime-sized area of the skin in women who have had a history of preeclampsia. As a compliment to these measurements, they also draw blood from the subjects and isolate the inflammatory cells.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 30, 2025
Est. primary completion date March 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion: - 18 years or older, - 12 weeks to 5 years postpartum - and one of the following: 1. women who had a normal pregnancy and did not use low does aspirin (LDA) during pregnancy, 2. women who had a normal pregnancy and used LDA during pregnancy, 3. women who had preeclampsia and did not use LDA during pregnancy, 4. women who had preeclampsia and used LDA during pregnancy. Exclusion: - current daily aspirin use, - skin diseases, - current tobacco use, - diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (CKD) defined as reduced eGFR < 60 mL/min/1.73m2, - statin or other cholesterol-lowering medication, - current antihypertensive medication, - history of hypertension prior to pregnancy, - history of gestational diabetes, - current pregnancy, - body mass index <18.5 kg/m2, - allergy to materials used during the experiment.(e.g. latex), - known allergies to study drugs.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Acetylcholine
acetylcholine, and acetylcholine + L-NAME (Nitric oxide synthase inhibitor) are locally and acutely delivered to the cutaneous microvasculature to assess endothelium- and nitric oxide-dependent dilation
Endothelin-1
endothelin-1, endothelin-1 + BQ-788 (endothelin receptor type B-inhibitor), and endothelin-1 + BQ-123 (endothelin receptor type A-inhibitor) are locally and acutely delivered to the cutaneous microvasculature to assess endothelin-mediated constriction and the role of the receptor subtypes in this response.

Locations

Country Name City State
United States University of Iowa Iowa City Iowa

Sponsors (1)

Lead Sponsor Collaborator
Anna Stanhewicz, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary microvascular endothelial function cutaneous vascular vasodilator response to exogenous acetylcholine perfusion; measured with laser-Doppler flowmetry coupled with intradermal microdialysis delivery of acetylcholine alone or co-infused with L-NAME at the study visit, an average of 4 hours
Primary microvascular endothelin-1-mediated constriction cutaneous vascular response to exogenous endothelin-1 perfusion; measured with laser-Doppler flowmetry coupled with intradermal microdialysis delivery of endothelin-1 alone or co-infused with BQ-788 or BQ-123 at the study visit, an average of 4 hours
See also
  Status Clinical Trial Phase
Completed NCT03510286 - Validation of a PrCr Dipstick Diagnostic Test in Ghana
Recruiting NCT03313024 - Berlin-Brandenburg Pregnancy Cohort
Active, not recruiting NCT04990141 - Molecular Screening Method for Preeclampsia (PREMOM)
Completed NCT02147626 - Heart Health 4 Moms Trial to Reduce CVD Risk After Preeclampsia N/A
Not yet recruiting NCT05999851 - Multiparametric Assessment of Maternal Vascular Function in the Prediction of Hypertensive Disorders of Pregnancy N/A
Recruiting NCT02923206 - Proof-of-Concept Trial on Selective Removal of sFlt-1 in Pregnant Women With Preeclampsia Via Apheresis N/A
Terminated NCT02558023 - The Treatment of Hypertension Associated With Severe Preeclampsia (PE). A Trial of Urapidil Versus Nicardipine Phase 3
Completed NCT02554604 - Identifying HDL Composition and Function in Preeclamptic and Normal Pregnancies
Completed NCT02384226 - User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study
Not yet recruiting NCT02541110 - Prediction of Preeclampsia & Other Obstetric Complications by Serum Homocysteine & Doppler N/A
Withdrawn NCT05016440 - Lisinopril for Renal Protection in Postpartum Preeclamptic Women N/A
Completed NCT02854501 - Second Trimester Maternal Serum Homocysteine Levels and Uterine Artery Doppler for Prediction of Preeclampsia and Placentation Disorders
Recruiting NCT02247297 - Pancreatic Stone Protein (PSP) in Pregnant Women
Recruiting NCT02337049 - Preeclampsia Subtypes and Surrogate Markers of CVD Risk N/A
Completed NCT02238704 - Cornell University-Micronutrient Initiative Calcium Supplementation Study N/A
Withdrawn NCT01179542 - The Involvement of Eukaryotic Translation Initiation Factor 4E (eIF4E) in Human Placental Implantation and in the Pathological Pregnancies: Preeclampsia and IUGR N/A
Completed NCT01195441 - Prediction and Prevention of Preeclampsia by First Trimester Ultrasound N/A
Completed NCT00456118 - Study of the Role of Tissular Maternofetal Alloimmunization in Placentation Pathologies
Recruiting NCT00117546 - Cardiovascular and Autonomic Reactivity in Women With a History of Pre-eclampsia Phase 4
Completed NCT00787241 - Platelet Count Trends in Pre-eclamptic Parturients N/A