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The Impact of Pregnancy and Pregnancy-associated Hypertension on Human Uterine Myometrial Artery Reactivity

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ClinicalTrials.gov Identifier: NCT03888170
Recruitment Status : Not yet recruiting
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Collaborator:
Midwestern University
Information provided by (Responsible Party):
University of Arizona

Study Description
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Brief Summary:
The investigators seek to describe the composition, architecture, and electrical conduction properties of the human uterine myometrial artery and their impact on vascular reactivity upon exposure to hypertensive stress. Non-pregnant women and pregnant women with and without hypertensive complications will be studied to evaluate the influence of these states on the myometrial arteries. Vascular over-reactivity and disruption of the normal pregnancy-associated physiologic changes of relaxed vascular tone possess the potential for non-compensated blood flow to the uterus and placenta that is insufficient to meet the metabolic demands of a growing placenta. With an understanding of these changes, the research team will be able to propose basic mechanistic changes of pathologic myogenic tone that may ultimately be investigated as potentially modifiable processes to reduce the development and/or severity of these pregnancy complications (gestational hypertension, preeclampsia, eclampsia, small for gestational age, intrauterine growth restriction and intrauterine fetal demise. ).

Condition or disease Intervention/treatment
Pregnancy Preeclampsia Hypertension in Pregnancy Other: No intervention

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Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Pregnancy and Pregnancy-associated Hypertension on Human Uterine Myometrial Artery Reactivity
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Non-pregnant
Women aged 18-45 years old undergoing elective hysterectomy (either vaginal, laparoscopic, or open routes) for benign indications.
 Other: No intervention
No intervention
Pregnant
Pregnant women aged 18-45 undergoing cesarean section at or beyond 34 weeks gestational age.
 Other: No intervention
No intervention
Pregnant with hypertension
Pregnant women aged 18-45 undergoing cesarean section at or beyond 34 weeks gestational age with pregnancy complicate by chronic hypertension, gestational hypertension, preeclampsia without severe features, preeclampsia with severe features, or superimposed preeclampsia.
 Other: No intervention
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Pressure-induced vasoconstriction of human uterine myometrial arteries [% constriction = ((passive vessel diameter - active vessels diameter) / passive diameter) X 100] [ Time Frame: Pressure-induced vasoconstriction will be assessed immediately following specimen acquisition and dissection to isolate the artery of interest. This occurs as a single time point of measurement, less than 24 hours following specimen acquisition. ]
    Pressure-induced constrictions (PIC) are expressed as a percent decrease of the fully dilated diameter of individual arteries at the same intravascular pressure. Diameter values will be analyzed as percent constriction. The passive diameter of the artery is measured in calcium-free physiologic saline solution containing 80 µM diltiazem. In turn, the active diameter of the myometrial artery is measured in response to calcium-containing physiologic saline solution. Both measurements will be obtained and measured across a physiologic range of blood pressures.


Secondary Outcome Measures :
  1. Changes in pressure-induced vasoconstriction in response to blockade of voltage-dependent potassium channels. [ Time Frame: Pressure-induced vasoconstriction will be assessed immediately following specimen acquisition and dissection to isolate the artery of interest. This occurs as a single time point of measurement, less than 24 hours following specimen acquisition. ]
    Pressure-induced constrictions (PIC) are expressed as a percent decrease of the fully dilated diameter of individual arteries at the same intravascular pressure. Diameter values will be analyzed as percent constriction.

  2. Changes in pressure-induced vasoconstriction in response to blockade of prostaglandin production. [ Time Frame: Pressure-induced vasoconstriction will be assessed immediately following specimen acquisition and dissection to isolate the artery of interest. This occurs as a single time point of measurement, less than 24 hours following specimen acquisition. ]
    Pressure-induced constrictions (PIC) are expressed as a percent decrease of the fully dilated diameter of individual arteries at the same intravascular pressure. Diameter values will be analyzed as percent constriction. The passive diameter of the artery is measured in calcium-free physiologic saline solution containing 80 µM diltiazem. In turn, the active diameter of the myometrial artery is measured in response to calcium-containing physiologic saline solution. Both measurements will be obtained and measured across a physiologic range of blood pressures.

  3. Changes in pressure-induced vasoconstriction in response to blockade of nitric oxide synthase. [ Time Frame: Pressure-induced vasoconstriction will be assessed immediately following specimen acquisition and dissection to isolate the artery of interest. This occurs as a single time point of measurement, less than 24 hours following specimen acquisition. ]
    Pressure-induced constrictions (PIC) are expressed as a percent decrease of the fully dilated diameter of individual arteries at the same intravascular pressure. Diameter values will be analyzed as percent constriction. The passive diameter of the artery is measured in calcium-free physiologic saline solution containing 80 µM diltiazem. In turn, the active diameter of the myometrial artery is measured in response to calcium-containing physiologic saline solution. Both measurements will be obtained and measured across a physiologic range of blood pressures.


Biospecimen Retention:   Samples Without DNA
  1. Blood Draw - venous blood samples will be collected from all patients for measurement of circulating hormone and inflammatory marker levels.

  2. Tissue/Amniotic Fluid Collection

    1. Samples from Cesarean section: amniotic fluid specimen, fetal membranes and placental biopsy, and a full-thickness uterine biopsy.
    2. Myometrial samples from elective hysterectomy: full-thickness uterine biopsy.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnancy
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients eligible for inclusion in this study protocol will be aged 18 years-old and older, all of which will be female. Additionally, study subjects may or may not be pregnant. There will be no restrictions based on race or ethnic group.
Criteria

Inclusion Criteria:

  • Women aged 18-45 years old
  • Non-pregnant women undergoing elective hysterectomy (either vaginal, laparoscopic, or open routes) for benign indications.
  • Pregnant women undergoing cesarean section at early-term and beyond (> 34 weeks)

Exclusion Criteria:

  • Pregnancy < 34 weeks gestation.
  • Non-English speaking
  • Cesarean section performed with non-low transverse hysterotomy.
  • History of uterine rupture or cesarean scar dehiscence, currently pregnant.
  • Uterine window or significant myometrial thinning appreciated at time of surgery.
  • Hysterectomy performed for treatment of malignancy
  • Hysterectomy performed for risk-reduction purposes in setting of genetic predisposition to gynecologic cancer
  • Diagnosis of infectious disease and/or blood borne illness
  • Learning or developmental disability that precludes appropriate consenting procedures
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888170


Contacts
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Contact: Michael P Leovic, MD 4404879605 mleovic@email.arizona.edu
Contact: Regina Montero, MSN 4802398697 rmontero52@email.arizona.edu

Sponsors and Collaborators
University of Arizona
Midwestern University
Investigators
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Principal Investigator: Michael P Leovic, MD University of Arizona
More Information
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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03888170     History of Changes
Other Study ID Numbers: 1902347880
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Non-applicable

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Arizona:
Myogenic Tone
Vascular Reactivity
Vascular Remodeling
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Hypertension
 Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications