Adipokines Effect in Myometrial Contractility

Study Overview
=================
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

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

Conditions
-----------------
GDM, Myometrium; Contractility, Obesity

Intervention / Treatment
-----------------
* Biological: Adiponectin and TNFa


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>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<br>* Adiponectin and TNFa are adipokines. Will be added to the myometrial biopsies to investigate their effect on the force of contractility<br>|
| Study group 1<br>Term pregnant, non-obese (BMI <30), diagnosed with gestational diabetes, scheduled for CS delivery between 37-41 weeks of gestation. | Biological: Adiponectin and TNFa<br>* Adiponectin and TNFa are adipokines. Will be added to the myometrial biopsies to investigate their effect on the force of contractility<br>|
| Study group 2<br>Term pregnant, obese (BMI >30), non-diabetic and scheduled for CS delivery between 37-41 weeks of gestation | Biological: Adiponectin and TNFa<br>* Adiponectin and TNFa are adipokines. Will be added to the myometrial biopsies to investigate their effect on the force of contractility<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |