Carbetocin Trial: Carbetocin Appropriate Rate Better Equilibrium Between

Status Completed

Clinical Trial Summary

Postpartum haemorrhage (PPH) is an obstetric emergency and defined as a blood loss of ≥500ml after vaginal birth and ≥1000ml after caesarean section (CS) and/or the need for blood transfusion within 24 hours after delivery (World Health Organization, Recommendations for the Prevention of Postpartum Haemorrhage. 2007; Leduc et al., J Obstet Gynaecol Can, 2009). Since PPH is more common after caesarean deliveries than after vaginal births and the rate of CS is rising over time and will probably continue to rise, the incidence of PPH is expected to increase accordingly.

A meta-analysis has shown that routine administration of an oxytocic agent after caesarean delivery leads to a reduced blood loss and decreases the risk of PPH (Cotter et al., Cochrane Database Syst Rev, 2001). The two most commonly used oxytocic drugs after operative delivery are oxytocin and carbetocin, a synthetic oxytocin-analogue. Carbetocin has the advantage over oxytocin of having a longer half-life and therefore reducing the use of additional uterotonics. Based on the findings of reduced cardiovascular side-effects with a short-infusion as compared to a bolus injection found for oxytocin (Thomas et al., Br J Anaesth, 2007), our study hypothesis is that a slower administration rate of carbetocin minimises the cardiovascular side effects without compromising the uterine tone. Therefore, we aim to investigate a short infusion of carbetocin 100 mcg applied in 100ml sodium chlorid compared to a bolus application in women undergoing primary or secondary caesarean delivery. This prospective, double-blind, randomised controlled non-inferiority trial will take place at the University Hospital Basel, Switzerland. We hypothesize uterine contraction not to be inferior (primary efficacy endpoint) and the mean arterial pressure to be higher after a short-infusion than after a bolus administration (primary safety endpoint).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02221531
Study type	Interventional
Source	University Hospital, Basel, Switzerland
Contact
Status	Completed
Phase	Phase 4
Start date	August 2014
Completion date	November 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03052699` - Medium and Long-term Complications of the Patients Having Had a Vaginal Caesarian in Hospital René Dubos	N/A
Completed	`NCT01412073` - Control of Blood Loss During Caesarean Section	Phase 3
Completed	`NCT01851187` - Effect of Perinatal Emotional Management on Maternal Emotion and Delivery Outcomes	N/A
Completed	`NCT01890720` - Incisional Negative Pressure Wound Therapy for Prevention of Postoperative Infections Following Caesarean Section	N/A
Completed	`NCT02542748` - Comparison of Norepinephrine and Ephedrine on Hypotension After Spinal Anesthesia in Parturients	N/A
Enrolling by invitation	`NCT02694653` - Preoperative Cesarean Section Intravenous Acetaminophen and Postoperative Pain Control	Phase 1
Completed	`NCT01723605` - Insitu Repair Versus Uterine Exeriorization During Cesarean Section	Phase 3
Withdrawn	`NCT01516697` - Non-invasive Cardiac Output Monitoring in Obstetric Patients	Phase 4
Completed	`NCT01741610` - Fluid Coloading and the Incidence of Hypotension	Phase 4
Terminated	`NCT02838017` - Tissue Adhesive vs. Sterile Strips After Cesarean Delivery	N/A
Completed	`NCT02587013` - Comparison of Uterine Repair Methods for Cesarean Delivery	N/A
Terminated	`NCT02036697` - Hemodynamic Effects of Low Dose Spinal Anesthesia for Cesarean Section	N/A
Recruiting	`NCT01954719` - Is Routine Cervical Dilatation Necessary During Elective Caesarean Section? A Randomised Controlled Trial	N/A
Terminated	`NCT02799667` - Do Single Use Negative Pressure Dressings Reduce Wound Complications in Obese Women After Cesarean Delivery	N/A
Completed	`NCT02459093` - Subcuticular Suture for Cesarean Skin Incision Closure	Phase 4
Completed	`NCT01858467` - Supreme LMA and Endotracheal Intubation Use in Caesarean Section	N/A
Completed	`NCT01891006` - Intervention for Postpartum Infections Following Caesarean Section	N/A
Withdrawn	`NCT02893696` - Extra Sitting Time After Spinal Anesthesia for Cesarean Section and Fetal Well-being	N/A
Completed	`NCT02785094` - Education and Social Media Versus Non-Indicated Caesarean Section Rate in Egypt	N/A
Completed	`NCT02332278` - Early Oral Feeding Versus Traditional Postoperative Care After Cesarean Section.	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Carbetocin Trial: Carbetocin Appropriate Rate Better Equilibrium Between Tonus (TOnus) and CIrculatioN — CARBETOCIN

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms