Mechanisms of Pregnancy Vascular Adaptations

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-20

Study Completion Date

2027-04-30

Brief Summary

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The investigators will collect omental tissue (research surgical excision) and placental tissue (standard of care clinical delivery) from both preeclamptic and non-preeclamptic women during their c-section and use these samples to study the blood vessels, specifically the expression/activation of the AT2R.

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Detailed Description

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Trial Design: The study is a comparison of two cohorts, those with and without preeclampsia during pregnancy. The team plans to investigate role of FABP4, PFAS and AT2 in modulation of vascular function/dysfunction using vessels isolated from the omental biopsies. The investigators will examine for the evidence of fetal vascular dysfunction mediated by decreased expression of AT2 in preeclampsia using vessels isolated from the placentas.

Study Population: The study will include pregnant women. The pregnant women will participate in the omental tissue collection, placenta collection, and the medical record review.

The study is expects a maximum enrollment of 114 pregnant women. This is because 52 omental biopsies and 52 placentas are required to meet proposed statistical considerations. Participants have the option of providing just one or both of the specimens. There is a possibility as few as 52 participants could be enrolled and a maximum of 104 participants could be enrolled to meet this requirement. There is an additional 10 participants enrollment built into the enrollment number to allow for replacement of subjects based on lack of clinical data in some participants, failure of tissue viability and hence experiments, and thus a maximum of 114 (104+10) participants could be enrolled.

This required enrollment (52) is divided into two cohorts based on the diagnosis of preeclampsia: 26 of each type of specimen in which the woman was diagnosed with preeclampsia during her pregnancy, and 26 of each type of specimen in which the woman was not diagnosed with preeclampsia during her pregnancy. Additionally, each cohort of 26 will be divided into two groups based on gender of the fetus, 13 male fetuses and 13 female fetuses

Conditions

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Pre-Eclampsia Vascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1 no Preeclampsia

Cohort 1: 26 mothers with no diagnosis of preeclampsia during pregnancy (13 male, 13 female neonate) Omental Biopsy and placental collection will be performed

Omental Biopsy

Intervention Type PROCEDURE

The surgeon and clinical care team will conduct the c-section to deliver the baby and the placenta as clinically indicated. After delivery, during the closing procedures, the surgeon will indicate a time for a participating Ob/Gyn physician on the study team to collect the omental bio-specimen. Omentum is frequently excised or removed for clinical reasons during surgical procedures. Omentum has small blood vessels within it that have been used for evaluation of vascular functional changes in research. The investigators wish to isolate one to three vessels of 5 to 7 cm length. The surgeon will then close and the clinical care team will resume their standard of care activities.

Cohort 2 mild or severe Preeclampsia

Cohort 2: 26 mothers with diagnosis of mild or severe preeclampsia during pregnancy (13 male, 13 female neonate) Omental Biopsy and placental collection will be performed

Omental Biopsy

Intervention Type PROCEDURE

The surgeon and clinical care team will conduct the c-section to deliver the baby and the placenta as clinically indicated. After delivery, during the closing procedures, the surgeon will indicate a time for a participating Ob/Gyn physician on the study team to collect the omental bio-specimen. Omentum is frequently excised or removed for clinical reasons during surgical procedures. Omentum has small blood vessels within it that have been used for evaluation of vascular functional changes in research. The investigators wish to isolate one to three vessels of 5 to 7 cm length. The surgeon will then close and the clinical care team will resume their standard of care activities.

Interventions

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Omental Biopsy

The surgeon and clinical care team will conduct the c-section to deliver the baby and the placenta as clinically indicated. After delivery, during the closing procedures, the surgeon will indicate a time for a participating Ob/Gyn physician on the study team to collect the omental bio-specimen. Omentum is frequently excised or removed for clinical reasons during surgical procedures. Omentum has small blood vessels within it that have been used for evaluation of vascular functional changes in research. The investigators wish to isolate one to three vessels of 5 to 7 cm length. The surgeon will then close and the clinical care team will resume their standard of care activities.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* female
* Minimum age: 18
* Maximum age: 40
* Singleton births
* Minimum gestational age at consent: 28 weeks, 0 days
* Maximum gestational age at consent: 41 weeks, 0 days
* Undergoing caesarean section, either planned or otherwise with or without trial of labor

Exclusion Criteria

* Preexisting hypertension treated by antihypertensive agents during the prenatal period. This will not include treatment of severe hypertension by antihypertensive or use of magnesium sulfate after the patient is hospitalized for the diagnosis of preeclampsia.
* Any major fetal structural anomalies or aneuploidies
* Preexisting conditions like pre-gestational type I or type II diabetes mellitus, pre-pregnancy kidney disease with increased serum creatinine above 1.2 mg/dL, or other underlying blood vessel problems like systemic lupus erythematosus or other autoimmune conditions with evidence of pre-pregnancy proteinuria or hypertension.
* Undergoing cesarean section for placental abruption or bleeding complications.
* Singleton gestation not within 36 weeks, 0 days and 41 weeks, 0 days gestational age at the time of enrollment (delivery)

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No