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OpenTrials
Completed

NCT Number: NCT03505541

Adipokines Effect in Myometrial Contractility

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

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Key information

Conditions

Myometrium; Contractility Body Weight GDM Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Fairview Hospital

Minneapolis, Minnesota, 55344, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Adiponectin and TNFa

Biological

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 23, 2018
Registry last updated
Jul 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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