Adipokines Effect in Myometrial Contractility

Completed

• Conditions: Myometrium; Contractility; GDM; Obesity
• Interventions: Biological: Adiponectin and TNFa

• Registration Number: NCT03505541
• Lead Sponsor: University of Minnesota

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-12
• Study First Posted: 2018-04-23
• Study Start: 2018-08-01
• Primary Completion: 2019-06-30
• Status Verified: 2019-07
• Study Completion: 2019-07-01
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study group 2	Adiponectin and TNFa	Term pregnant, obese (BMI \>30), non-diabetic and scheduled for CS delivery between 37-41 weeks of gestation
Study group 1	Adiponectin and TNFa	Term pregnant, non-obese (BMI \<30), diagnosed with gestational diabetes, scheduled for CS delivery between 37-41 weeks of gestation.
Control group	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (1)

Fairview Hospital; 🇺🇸 Minneapolis, Minnesota, United States