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Adipokines Effect in Myometrial Contractility

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ClinicalTrials.gov Identifier: NCT03505541
Recruitment Status : Recruiting
First Posted : April 23, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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

Condition or disease Intervention/treatment
Myometrium; Contractility GDM Obesity Biological: Adiponectin and TNFa

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Adiponectin and TNFa on Uterine Contractility in GDM and Obese Pregnant Patients
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 1, 2019

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant subjects undergoing a scheduled C-section delivery.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03505541


Contacts
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Contact: hiba mustafa, MD 8324754061 musta062@umn.edu

Locations
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United States, Minnesota
Fairview Hospital Recruiting
Minneapolis, Minnesota, United States, 55344
Contact: Hiba Mustafa, MD    612-273-4040    musta062@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Katherine Jacobs, MD University of Minnesota - Clinical and Translational Science Institute
  Study Documents (Full-Text)

Documents provided by University of Minnesota - Clinical and Translational Science Institute:
Study Protocol  [PDF] February 26, 2018
Informed Consent Form  [PDF] February 26, 2018


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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03505541     History of Changes
Other Study ID Numbers: STUDY00002972
First Posted: April 23, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No