Adipokines Effect in Myometrial Contractility

July 17, 2019 updated by: University of Minnesota

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55344
        • Fairview Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Pregnant subjects undergoing a scheduled C-section delivery.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Healthy, term, non-obese (BMI < 30) pregnant women with a singleton gestation scheduled for CS delivery at 37-41 weeks of gestation.
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
Study group 1
Term pregnant, non-obese (BMI <30), diagnosed with gestational diabetes, scheduled for CS delivery between 37-41 weeks of gestation.
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
Study group 2
Term pregnant, obese (BMI >30), non-diabetic and scheduled for CS delivery between 37-41 weeks of gestation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on force of contractility
Time Frame: 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
24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Katherine Jacobs, MD, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (Actual)

April 23, 2018

Study Record Updates

Last Update Posted (Actual)

July 18, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • STUDY00002972

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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