Carbetocin in the Prevention of Primary Postpartum Haemorrhage

Status Completed

Clinical Trial Summary

Postpartum haemorrhage (PPH) ranks as the first cause of maternal mortality in developing countries and it is the cause of 25% of maternal deaths worldwide. Carbetocin is a long-acting synthetic octapeptide analogue of oxytocin with agonist properties. Like oxytocin, carbetocin binds to oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic contractions of the uterus, increased frequency of existing contractions and increased uterine tone.

Clinical Trial Description

Postpartum hemorrhage is defined as a blood loss more than 500 ml, and serious PPH as a blood loss more than 1,000 ml. It is a common maternal morbidity in high-resource countries and is trending upward and prevention of postpartum haemorrhage is, therefore, of great importance for improved maternal health care. Although two-thirds of the PPH cases occur in women without predisposing factors, there are several risk factors for PPH. The most frequent cause of PPH is uterine atony, contributing up to 80 % of the PPH cases . Studies investigating effect of increased BMI on birth outcomes in a general obstetric population revealed an association between obesity and PPH. The overall increased risk of postpartum hemorrhage among obese women was 8-13%, depending on obesity class. The risk of postpartum haemorrhage is much higher for women undergoing Cesarean section, particularly in developing countries, where the majority of operations are carried out as an emergency procedure. Maternal obesity is associated with an elevated risk of intrapartum cesarean section, mainly due to reduced uterine contractility culminating in failure to progress in labor . Up to date, which uterotonic agent suitable for prophylactic use is being debated and literature lacks of clear endpoints on this item . The most routinely and widely used uterotonic agent for preventing postpartum haemorrhage is oxytocin, but it only has a half-life of 4-10 min. So, it must be administered as a continuous intravenous infusion to achieve sustained uterotonic activity, which is inconvenient and makes dosing errors a possibility. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06159959
Study type	Observational
Source	Ministry of Health and Population, Egypt
Contact
Status	Completed
Phase
Start date	January 1, 2023
Completion date	October 30, 2023

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT03693599` - Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean	Phase 4
Completed	`NCT03707132` - Tourniquet Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta
Recruiting	`NCT02306733` - Ergometrine Versus Oxytocin in the Management of Atonic Post-partum Haemorrhage (PPH) in Women Delivered Vaginally	Phase 3
Completed	`NCT01866241` - Combating Maternal Mortality in Uganda: An Assessment of the Role of Misoprostol in Prevention of Post-Partum Hemorrhage	Phase 3
Not yet recruiting	`NCT01236482` - Oxytocin in Cesarean Delivery	Phase 4
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Recruiting	`NCT04401839` - Amr Maneuver for Prevention of Postpartum Hemorrhage	N/A
Not yet recruiting	`NCT06219538` - DAISY Uterine Drain Device Evaluation	N/A
Completed	`NCT01863706` - Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage	Phase 1
Not yet recruiting	`NCT05488457` - Oxytocin Pharmacokinetics and Pharmacodynamics	Phase 2
Completed	`NCT04723979` - NovoSeven® in Severe Postpartum Haemorrhage - Experiences From UK, DK, FR, NL
Terminated	`NCT04277962` - Estimating Blood Loss Using TritonTM in Vaginal Deliveries: A Validation Trial	N/A
Completed	`NCT03570723` - Glove-loaded Foley's Catheter Tamponade for Cesarean Section for Placenta Previa	N/A
Completed	`NCT03117647` - Mansoura-VV Uterine Compression Suture for Primary Atonic Postpartum Hemorrhage	N/A
Active, not recruiting	`NCT03069859` - Use of TXA to Prevent Postpartum Hemorrhage	Phase 2
Not yet recruiting	`NCT03891082` - A Comparative Study Between Bakri Balloon and B Lynch Suture Used to Control Primary Postpartum Hemorrhage After Cesarean Section	N/A
Not yet recruiting	`NCT03463070` - Misoprostol Before and After Cesarean Section	Phase 3
Recruiting	`NCT05532215` - Sublingual Misoprostol in Reduction of Caesarean Blood Loss	N/A
Not yet recruiting	`NCT06255496` - QStat Cartridge in Obstetric Patients

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.