Effects of medications on uterine contractions during cesarean delivery in diabetic patients
Effect of Ephedrine, Phenylepinephrine, and Norepinephrine on Myometrial Contractility in Pregnant People With Type II and Gestational Diabetes During Cesarean Section: An In-vitro Study
This study is testing how certain medications for low blood pressure during cesarean deliveries affect uterine contractions in women with Type II and gestational diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 19 Years to 45 Years |
| Sex | Female |
| Sponsor | Samuel Lunenfeld Research Institute, Mount Sinai Hospital Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06285396 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include pregnant individuals aged 19-45 with Type II or gestational diabetes, scheduled for elective cesarean delivery under spinal anesthesia.
Not a fit: Patients who are in labor, require general anesthesia, or have had previous uterine surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of uterine contractility and reduced risk of postpartum hemorrhage in diabetic patients during cesarean deliveries.
How similar studies have performed: While the specific approach of this study may be novel, there is existing literature on the effects of vasopressors on uterine contractility, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.