Current partner codePEPTIDESDE
NCT06159959·Not applicable·OBSERVATIONAL

Carbetocin in the Prevention of Primary Postpartum Haemorrhage

Status

Completed

Phase

Not applicable

Enrollment

244

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed 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.

Interventions

Treatment arms and agents.

DRUG

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.

Timeline

From registration to results.

  1. First posted

    Dec 7, 2023

  2. Study start

    Jan 1, 2023

  3. Primary completion

    Oct 1, 2023

  4. Study completion

    Oct 30, 2023

  5. Results posted

    Not reported

  6. Registry updated

    Dec 7, 2023

Outcomes

What the study measures.

Primary outcomes

Post postpartum bleeding

Time frame · first 6 hours after the Cesarean Section

To compare the incidence of primary postpartum hemorrhage in both groups receiving carbetocin

Secondary outcomes

Sever PPH as bleeding is >1000 cc

Time frame · first 24 hours after Cesarean Section

Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level post operatively.

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
40 Years
Sex
FEMALE
Healthy volunteers
Yes

Inclusion Criteria: * Age: 20-40years. * 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 who have any factors that might increase the risk of postpartum haemorrhage will be excluded as anemic patients (Hb\<10.5g%), antepartum haemorrhage ( placenta previa, placental abruption ), uterine myomata, multiple gestation, polyhydramnios. * Patients with pre-existing bleeding or thromboembolic disorder. * Patients with chronic medical diseases (cardiac, hepatic, renal)

Study locations

1 registered sites.

Egypt. Showing up to 24 locations stored in the fast local snapshot.

Kasr- Alainy Hospitals

Cairo, Egypt

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Carbetocin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.