protocolSection identificationModule nctId: NCT06285396, orgStudyIdInfo id: 24-01, briefTitle: 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, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-18, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-07, studyFirstPostDateStruct date: 2024-02-29, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Samuel Lunenfeld Research Institute, Mount Sinai Hospital, class: OTHER, descriptionModule briefSummary: The goal of this study is to learn about how medication that is used to help treat low blood pressure during a Cesarean delivery (CD) can cause changes to the uterine muscle tissue and its ability to contract, in patients with Type II and gestational diabetes.Spinal anesthesia administered during elective CD has been known to cause hypotension (low blood pressure) as a side effect during the procedure, and is prevented by administration of vasopressors (medication to raise blood pressure) by the anesthesiologist after the delivery of the baby. Vasopressors treat hypotension by interacting with receptors on blood vessels that increase blood pressure, which can also cause changes to uterine contractility. Inadequate uterine contraction after CD can expose mothers to postpartum hemorrhage (PPH), with diabetic patients displaying a 2.5-times higher risk of PPH.It is important to understand how vasopressor(s) might affect the uterine contractility of women with Type II and gestational diabetes. Since medication to contract the uterus is also routinely administered at delivery, it is important to study the effect of these drugs in combination. The purpose of this study is to compare uterine contractility patterns and receptor distribution in women with type II and gestational diabetic and control term pregnant patients with administration of vasopressors. This will be done using small uterine tissue samples taken from the incision site following CD, which will then be used for experiments in the laboratory., conditionsModule conditions: Postpartum Hemorrhage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Ephedrine, interventions name: Phenylephrine, interventions name: Norepinephrine, interventions name: Oxytocin, outcomesModule primaryOutcomes measure: Motility index, secondaryOutcomes measure: Amplitude of contraction, secondaryOutcomes measure: Frequency of contraction, secondaryOutcomes measure: Integrated area under response curve (AUC), eligibilityModule sex: FEMALE, minimumAge: 19 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Mount Sinai Hospital, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G1X5, country: Canada, contacts name: Mrinalini Balki, MD, role: CONTACT, phone: 416-586-4800, phoneExt: 5270, email: mrinalini.balki@uhn.ca, contacts name: Caroline Carruthers, role: SUB_INVESTIGATOR, contacts name: Joseph Park, BSc, role: SUB_INVESTIGATOR, contacts name: Cynthia Maxwell, MD, role: SUB_INVESTIGATOR, contacts name: Anuradha Baishnob, BSc, role: SUB_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False