The Impact of Pregnancy and Pregnancy-associated Hypertension on Human Uterine Myometrial Artery Reactivity
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03888170 |
Recruitment Status :
Not yet recruiting
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment |
---|---|
Pregnancy Preeclampsia Hypertension in Pregnancy | Other: No intervention |

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 |

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 |
- 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.
- 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.
- 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.
- 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
- Blood Draw - venous blood samples will be collected from all patients for measurement of circulating hormone and inflammatory marker levels.
-
Tissue/Amniotic Fluid Collection
- Samples from Cesarean section: amniotic fluid specimen, fetal membranes and placental biopsy, and a full-thickness uterine biopsy.
- Myometrial samples from elective hysterectomy: full-thickness uterine biopsy.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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

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
Contact: Michael P Leovic, MD | 4404879605 | mleovic@email.arizona.edu | |
Contact: Regina Montero, MSN | 4802398697 | rmontero52@email.arizona.edu |
Principal Investigator: | Michael P Leovic, MD | University of Arizona |
Responsible Party: | University of Arizona |
ClinicalTrials.gov Identifier: | NCT03888170 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Myogenic Tone Vascular Reactivity Vascular Remodeling |
Pre-Eclampsia Hypertension, Pregnancy-Induced Hypertension |
Vascular Diseases Cardiovascular Diseases Pregnancy Complications |