Cesarean Delivery
Conditions
Brief summary
Carbetocin is an oxytocin agonist used for prevention of postpartum bleeding after cesarean delivery. First studies revealed in 2012 an analgesic effect of carbetocin, compared to its parent substance oxytocin. This study will enroll 78 women undergoing cesarean delivery. In a double-blind, prospective design patients will be either attributed to the oxytocin or the carbetocin study arm. The primary endpoint will be the area of hyperalgesia around the cesarean delivery scar. This will be performed with a von Frey hair, resulting in a unpleasant feeling in the area of hyperalgesia.
Interventions
DRUGCarbetocin
Postpartum uterotonic drug
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-45, uneventful pregnancy, on term (\>37 0/7 weeks of gestation), scheduled elective CS including repeat CS
Exclusion criteria
* lack of informed consent, active labor, multiple pregnancy, polyhydramnios, severe fetal malformations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cesarean delivery scar cutaneous hyperalgesia | 4 hours after cesarean delivery | In the area of the cesarean delivery scar, the area of dynamic secondary hyperalgesia for punctate mechanical stimuli around the surgical incision will be measured around her scar according to the method described by Stubhaug et al. In brief, stimulation with a Von Frey Filament (225.1gr) is started from outside the hyperalgesic area where no pain sensation is experienced toward the incision until the patient reports a distinct change in perception. The first point where a painful, sore, or sharp feeling appears is recorded, and the distance to the incision is measured. If no change in sensation appears, stimulation is stopped at 0.5 cm from the incision. The area of secondary hyperalgesia is determined by testing along radial lines separated by 5 cm around the incision. The observations are translated onto graph paper, and the surface is calculated as cm2/cm of incision. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pressure pain detection threshold | before cesarean | Pain detection thresholds will be measured with an electronic pressure algometer (Algometer, Somedic, Denmark) applied at the center of the pulp of the 2nd toe. The probe has a surface area of 1 cm2. The pressure is increased from 0 at a rate of 30kPa/s to a maximum pressure of 1000kPa. Pain detection threshold is defined as the point at which the pressure sensation turns to pain. The subjects are instructed to press a button when these points are reached. The algometer displays the pressure intensity at which the button is pressed. If the subjects do not press the button at a pressure of 1000 kPa, this value is considered as threshold. |
| Baseline depression detection | before cesarean | Beck Depression Inventory (BDI-II): a 21 question multiple choice inventory used to measure severity of depression. This will be used in order to assess an eventual prepartum depression, this measure aims at eliminating bias if detecting a postpartum depression by the Edinburgh Depression questionnaire |
| Postpartum depression | 6 weeks post cesarean | Assessment of postpartum depression with the Edinburgh Postnatal Depression Scale. It is a 10 item questionnaire. |
| Cesarean delivery scar cutaneous hyperalgesia | 24 hours after cesarean | In the area of the cesarean delivery scar, the area of dynamic secondary hyperalgesia for punctate mechanical stimuli around the surgical incision will be measured around her scar according to the method described by Stubhaug et al. In brief, stimulation with a Von Frey Filament (225.1gr) is started from outside the hyperalgesic area where no pain sensation is experienced toward the incision until the patient reports a distinct change in perception. The first point where a painful, sore, or sharp feeling appears is recorded, and the distance to the incision is measured. If no change in sensation appears, stimulation is stopped at 0.5 cm from the incision. The area of secondary hyperalgesia is determined by testing along radial lines separated by 5 cm around the incision. The observations are translated onto graph paper, and the surface is calculated as cm2/cm of incision. |
Countries
Switzerland
Contacts
Primary ContactPascal H Vuilleumier, MD
Backup ContactJuerg Schliessbach, MD
Outcome results
None listed