About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Ephedrine
DrugEphedrine in solution, at applicable concentrations based on literature.
Phenylephrine
DrugPhenylephrine, at applicable concentrations based on literature.
Norepinephrine
DrugNorepinephrine, at applicable concentrations based on literature.
Oxytocin
DrugOxytocin, at applicable concentrations based on literature.
Treatment groups
8
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Motility index
Motility index (MI) is a calculated outcome, based on the formula: frequency/(10 x amplitude). Frequency and amplitude are secondary outcome measures as described below. The analysis is undertaken by attaching myometrial strips between an isometric force transducer and the base of an organ bath chamber.
Secondary outcomes
Amplitude of contraction
The maximum extent of uterine muscle contraction, measured in grams (g). The analysis is undertaken by attaching myometrial strips between an isometric force transducer and the base of an organ bath chamber.
Frequency of contraction
The number of contractions in uterine muscle (myometrium) over 10 minutes, spontaneously and in response to an agonist. The analysis is undertaken by attaching myometrial strips between an isometric force transducer and the base of an organ bath chamber.
Integrated area under response curve (AUC)
Sponsors and contacts
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