Post Partum HemorrhageNCT06159959
Carbetocin in the Prevention of Primary Postpartum Haemorrhage
An observational study of Post Partum Hemorrhage, run by Ministry of Health and Population, Egypt at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- Carbetocin
- Type of treatment
- Injection or infusion
- How many people
- 244 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carbetocin in the Prevention of Primary Postpartum Haemorrhage in Obese Versus Non-obese Women Undergoing Elective Cesarean Section
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.
Read the 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.
- Conditions
- Post Partum Hemorrhage
- Being tested
- Carbetocin
- Keywords
- Obesity, PPH, BMI, Carbetocin, Oxytocin, Uterotonic
- Medical subject headings
- Postpartum Hemorrhage, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarbetocinDrug
Also called Oxytocin
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Carbetocin | |
| 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 Receives: Drug: Carbetocin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post postpartum bleeding
To compare the incidence of primary postpartum hemorrhage in both groups receiving carbetocin
Measured: first 6 hours after the Cesarean Section
Secondary outcomes (1)
Sever PPH as bleeding is >1000 cc
Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level post operatively.
Measured: first 24 hours after Cesarean Section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Jan 2023
- Primary completion1 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ministry of Health and Population, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dina Sanad Tawfik Allam, Ministry of Health and Population, Egypt
- Investigators
- Abdallah Y Elkateb, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159959
- Sponsor's protocol ID
- Dina Sanad Tawfik
- Status last verified
- Dec 2023
- First submitted
- 25 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbetocin in the Prevention of Primary Postpartum Haemorrhage in Obese Versus Non-obese Women Undergoing Elective Cesarean Section
- ClinicalTrials.gov ID
- NCT06159959
- Acronym / sponsor ID
- Dina Sanad Tawfik
- Conditions
- Post Partum Hemorrhage
- Keywords
- Obesity, PPH, BMI, Carbetocin, Oxytocin, Uterotonic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Ministry of Health and Population, EgyptOther government
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Obese Pregnant Females | – | Drug: CarbetocinAbout 122 Pregnant women candidate for elective cesarean section suffering from obesity where as Body mass index (BMI) is ≥30 kg/m2 |
| Group B: Non-Obese Pregnant Females | – | Drug: CarbetocinAbout 122 Pregnant women candidate for elective cesarean section and not obese obesity where as Body mass index (BMI) is < 30 kg/m2 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarbetocinAlso: OxytocinTo 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. | Drug | Group A: Obese Pregnant Females, Group B: Non-Obese Pregnant Females |
Primary outcome
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
1 secondary outcome
Sever PPH as bleeding is >1000 cc
Time frame: first 24 hours after Cesarean Section
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdallah Y Elkateb, Professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Partum Hemorrhage, run by Ministry of Health and Population, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post postpartum bleeding (time frame: first 6 hours after the Cesarean Section). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.