Adipokines Effect in Myometrial Contractility

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03505541
• Other study ID #: STUDY00002972
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• GDM
• Myometrium; Contractility
• Obesity

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