Adipokines Effect in Myometrial Contractility

NCT03505541 — Completed, 60 participants, University of Minnesota

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Effect of Adiponectin and TNFa on Uterine Contractility in GDM and Obese Pregnant Patients

Registry	NCT03505541
Status	Completed
Study type	Observational
Enrollment	60 (Actual)
Sponsor	University of Minnesota (Other)
Conditions	Myometrium; Contractility, GDM, Obesity
Interventions	Adiponectin and TNFa (Biological)
Dates	start 2018-08-01, primary completion 2019-06-30, completion 2019-07-01, first posted 2018-04-23, last updated 2019-07-18
Locations	1 site in United States

-Summary

Investigate the effect of two adipokines which are adiponectin and TNFa on the force of myometrial contractility in diabetic, non-obese pregnant women and obese, non-diabetic term pregnant women at the time of scheduled cesarean delivery

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+Arms and interventions

Arm	Interventions	Description
Control group	Biological: Adiponectin and TNFa	Healthy, term, non-obese (BMI < 30) pregnant women with a singleton gestation scheduled for CS delivery at 37-41 weeks of gestation.
Study group 1	Biological: Adiponectin and TNFa	Term pregnant, non-obese (BMI <30), diagnosed with gestational diabetes, scheduled for CS delivery between 37-41 weeks of gestation.
Study group 2	Biological: Adiponectin and TNFa	Term pregnant, obese (BMI >30), non-diabetic and scheduled for CS delivery between 37-41 weeks of gestation

Adiponectin and TNFa (Biological): Adiponectin and TNFa are adipokines. Will be added to the myometrial biopsies to investigate their effect on the force of contractility

+Outcome measures

Primary outcomes

Effect on force of contractility [24 hours]: Determine the effect of adiponectin and TNFa on the force of myometrial contractility in diabetic, non-obese pregnant women and obese, non-diabetic term pregnant women at the time of scheduled cesarean delivery

Secondary outcomes

Force of contractility between study groups [24 hours]: Compare the force of myometrial contractility in study groups compared to control group (non-DM, non-obese term pregnant patients)
Progesterone effect in control group [24 hours]: Investigate the anti-inflammatory properties of Progesterone (P4) and 17a-Hydroxyprogesterone (HPC) on Adiponectin induced myometrial contractility in control group

+Eligibility

Sex: Female, ages: 18 Years to 55 Years, accepts healthy volunteers

Inclusion Criteria:

* Pregnant patients scheduled for a CS at 37-41 weeks of gestation at M Health Birth Place
* Participants age ≥18.
* Full informed consent able to be provided by the participant.

Exclusion Criteria:

* Patients undergoing general anesthesia for their CS.
* Pre-gestational DM, and DM diagnosed <24 weeks gestation.
* Patients unable to consent for themselves
* Multiple gestation

+Locations (1)

Facility	City	Country	Status
Fairview Hospital	Minneapolis, Minnesota	United States

+Study documents

Study Protocol (PDF, 2018-02-26)
Informed Consent Form (PDF, 2018-02-26)

+Investigators

Katherine Jacobs, MD, Principal investigator, University of Minnesota

My Notes

Public

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