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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03505541
Other study ID # STUDY00002972
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date July 1, 2019

Study information

Verified date July 2019
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 1, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Fairview Hospital Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Effect on force of contractility 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 24 hours
Secondary Force of contractility between study groups Compare the force of myometrial contractility in study groups compared to control group (non-DM, non-obese term pregnant patients) 24 hours
Secondary Progesterone effect in control group Investigate the anti-inflammatory properties of Progesterone (P4) and 17a-Hydroxyprogesterone (HPC) on Adiponectin induced myometrial contractility in control group 24 hours
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