Effects of medications on uterine contractions during cesarean delivery in diabetic patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates how medications used to treat low blood pressure during cesarean deliveries affect the contractility of uterine muscle tissue in patients with Type II and gestational diabetes. It focuses on the impact of vasopressors like ephedrine, phenylephrine, and norepinephrine on myometrial function, as inadequate contractions can lead to postpartum hemorrhage, particularly in diabetic women. The research aims to provide insights into the relationship between these medications and uterine health during a critical time for mothers undergoing elective cesarean sections.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients who have given consent to participate in the study
* Patients with gestational age 37-41 weeks
* Patients previously diagnosed with either Type II or Gestational diabetes. For the healthy control group, no previous diagnosis is required for inclusion
* Patients of 19-45 years
* Patients of normal BMI (18-30 BMI) for the healthy control group only
* Baby is registered as normal weight for size for the healthy control group only
* Non-laboring patients, not exposed to exogenous oxytocin
* Patients requiring elective primary or first repeat caesarean delivery
* Patients undergoing caesarean delivery under spinal anesthesia

Exclusion Criteria:

* Patients who refuse to give written informed consent
* Patients who require general anesthesia
* Patients in labor and those receiving oxytocin for induction of labor
* Emergency caesarean delivery in labor
* Patients who have had previous uterine surgery involving myometrial dissection or \>1 previous caesarean delivery
* Patients with risk factors for PPH such as those with polyhydramnios, preeclampsia, multiple gestation, morbid obesity, macrosomia (large for size baby), and previous history of PPH. However, for diabetic group, those with morbid obesity and macrosomia will not be excluded as these conditions are almost always associated with diabetes.
* For the healthy control group only, a BMI \>30 or \<18
* Maternal age \>45

Where it's running

• Mount Sinai Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Mrinalini Balki, MD — Mount Sinai Hospital
• Study coordinator: Mrinalini Balki, MD
• Email: mrinalini.balki@uhn.ca
• Phone: 416-586-4800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.