Carbetocin in the Prevention of Primary Postpartum Haemorrhage
NCT ID: NCT06159959
Last Updated: 2023-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
244 participants
OBSERVATIONAL
2023-01-01
2023-10-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Group A: Obese Pregnant Females
About 122 Pregnant women candidate for elective cesarean section suffering from obesity where as Body mass index (BMI) is ≥30 kg/m2
Carbetocin
To assess the effectiveness of single IV bolus dose of carbetocin in the prevention of primary PPH in obese versus non obese women undergoing elective cesarean section.
Group B: Non-Obese Pregnant Females
About 122 Pregnant women candidate for elective cesarean section and not obese obesity where as Body mass index (BMI) is \< 30 kg/m2
Carbetocin
To assess the effectiveness of single IV bolus dose of carbetocin in the prevention of primary PPH in obese versus non obese women undergoing elective cesarean section.
Interventions
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Carbetocin
To assess the effectiveness of single IV bolus dose of carbetocin in the prevention of primary PPH in obese versus non obese women undergoing elective cesarean section.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI): Obese ≥30 kg/m2 and non-obese women \<30 kg/m2 calculated using maternal height and weight measured to the nearest centimeter and kilogram, respectively, at time of admission to labor word.
* Gestational age: Gestational age ≥37 weeks (gestational age will be recorded according to the last menstrual period and confirmed by ultrasound). In case of discrepancy, a 1st trimesteric ultrasound will be taken as the actual gestational age.
* Singleton pregnancy.
Exclusion Criteria
* Patients with pre-existing bleeding or thromboembolic disorder.
* Patients with chronic medical diseases (cardiac, hepatic, renal)
20 Years
40 Years
FEMALE
Yes
Sponsors
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Ministry of Health and Population, Egypt
OTHER_GOV
Responsible Party
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Dina Sanad Tawfik Allam
Specialist of Obstetrics and Gynecology at AlSahelTeaching Hospital
Principal Investigators
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Abdallah Y Elkateb, Professor
Role: STUDY_CHAIR
Cairo University
Locations
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Kasr- Alainy Hospitals
Cairo, , Egypt
Countries
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Other Identifiers
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Dina Sanad Tawfik
Identifier Type: -
Identifier Source: org_study_id