Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT06159959 |
Other study ID # |
Dina Sanad Tawfik |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 1, 2023 |
Est. completion date |
October 30, 2023 |
Study information
Verified date |
December 2023 |
Source |
Ministry of Health and Population, Egypt |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
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.
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.