Post Partum Hemorrhage Clinical Trial
Official title:
Comparative Efficacy of Carbetocin and Oxytocin in Parturients at Risk of Atonic Postpartum Hemorrhage Undergoing Elective Cesarean Delivery: a Randomized Controlled Trial
NCT number | NCT06333340 |
Other study ID # | 24-03 |
Secondary ID | |
Status | Not yet recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2024 |
Est. completion date | March 2025 |
The goal of this study is to compare 2 medications that are commonly used to prevent excess uterine bleeding (postpartum hemorrhage, or PPH) following cesarean delivery (CD), oxytocin and carbetocin. Most of the trials evaluating the preventative role of oxytocin and carbetocin after CD have focused on patient with low-risk of PPH. This trial will focus on patients that are at increased risk of PPH, with risk factors such as: multiple gestation (twins, or more multiples), large baby, polyhydramnios (excess amniotic fluid), history of PPH, body mass index greater than 40, diabetes mellitus, hypertension, and placenta previa. The investigators hypothesize that carbetocin would be more effective than an oxytocin regimen in reducing the risk of PPH in patients undergoing CD with any of the biological high-risk factors.
Status | Not yet recruiting |
Enrollment | 160 |
Est. completion date | March 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion criteria - Any one or more of the risk factors for uterine atony: - Overdistended uterus due to: - Polyhydramnios (amniotic fluid index >24 cm) - Fetal macrosomia reported on prenatal ultrasound >90th centile or > 4000 gm - Multiple gestation - History of uterine atony/PPH (documented with blood loss of >1000 ml, blood transfusion, use surgical methods such as Bakri balloon, B-Lynch sutures, uterine artery ligation or embolization) - Obesity with body mass index (BMI) >40 kg/m2 - Diabetes mellitus - Hypertensive disease (chronic hypertension or severe preeclampsia on treatment) - Placenta previa Exclusion criteria: - Valvular heart disease, arrhythmias, or heart failure - Placenta accreta spectrum - Bleeding disorder - Anemia (<100 g/dl) - Allergy or sensitivity to oxytocin or carbetocin |
Country | Name | City | State |
---|---|---|---|
Canada | Mount Sinai Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Samuel Lunenfeld Research Institute, Mount Sinai Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of parturients requiring additional uterotonic agents intraoperatively | The proportion of patients who are administered additional uterotonic agents intraoperatively will be divided by the total number of patients assigned to the same treatment arm, for each of the 2 groups: oxytocin and carbetocin. | 90 minutes | |
Secondary | Uterine Tone 3 minutes | The intensity of uterine tone as evaluated by palpation of the uterus by the obstetrician at 3 minutes, from the completion of delivery of the drug, utilizing a verbal numeric rating scale of 0-10. | 3 minutes | |
Secondary | Uterine Tone 5 minutes | The intensity of uterine tone as evaluated by palpation of the uterus by the obstetrician at 5 minutes, from the completion of delivery of the drug, utilizing a verbal numeric rating scale of 0-10. | 5 minutes | |
Secondary | Uterine Tone 10 minutes | The intensity of uterine tone as evaluated by palpation of the uterus by the obstetrician at 10 minutes, from the completion of delivery of the drug, utilizing a verbal numeric rating scale of 0-10. | 10 minutes | |
Secondary | Calculated blood loss (CBL) | Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 24 hours after the cesarean section. | 24 hours | |
Secondary | Semi-quantitative blood loss (SQBL) | Blood loss measured in the operating room by volume (ml) | 2 hours | |
Secondary | Presence of blood transfusion | Number of units of blood product administered post-delivery | 24 hours | |
Secondary | Number of patients with ICU admission | Admission to the intensive care unit for bleeding post partum | 24 hours | |
Secondary | Number of patients with conservative surgical methods to manage post partum hemorrhage | Bakri balloon/B-Lynch sutures used intraoperatively | 2 hours | |
Secondary | Number of patients with radiological methods used to manage post partum hemorrhage | Uterine artery embolization used intraoperatively. | 2 hours | |
Secondary | Number of patients with surgical post partum hemorrhage management measures | Re-exploration for bleeding/uterine artery ligation/hysterectomy | 2 hours | |
Secondary | Number of patients with hypotension defined as systolic blood pressure less than 80% of baseline | Systolic blood pressure < 80% of baseline, at any time during surgery | 2 hours | |
Secondary | Number of patients with hypertension defined as systolic blood pressure greater than 120% of baseline | Systolic blood pressure > 120% of baseline, at any time during surgery | 2 hours | |
Secondary | Number of patients with tachycardia defined as heart rate greater than 130% of baseline | Heart rate > 130% of baseline, at any time during surgery | 2 hours | |
Secondary | Number of patients with bradycardia defined as heart rate less than 70% of baseline | Heart rate < 70% of baseline, at any time during surgery | 2 hours | |
Secondary | Presence of ventricular tachycardia: ECG | Presence of ventricular tachycardia as recorded by ECG, at any time during surgery | 2 hours | |
Secondary | Presence of atrial fibrillation: ECG | Presence of atrial fibrillation as recorded by ECG, at any time during surgery | 2 hours | |
Secondary | Presence of atrial flutter: ECG | Presence of atrial flutter as recorded by ECG, at any time during surgery | 2 hours | |
Secondary | Presence of nausea: questionnaire | The presence of nausea at any time during surgery, as reported by the patient | 2 hours | |
Secondary | Presence of vomiting: questionnaire | The presence of vomiting at any time during surgery, as reported by the patient | 2 hours | |
Secondary | Number of patients with chest pain: questionnaire | Any presence of chest pain, at any time during surgery, as reported by the patient | 2 hours | |
Secondary | Number of patients with shortness of breath: questionnaire | Any presence of shortness of breath, at any time during surgery, as reported by the patient. | 2 hours | |
Secondary | Number of patients with headache: questionnaire | Any presence of headache, at any time during surgery, as reported by the patient. | 2 hours | |
Secondary | Number of patients with flushing: questionnaire | Any presence of flushing, at any time during surgery. | 2 hours |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03680339 -
The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS
|
Phase 4 | |
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 | |
Completed |
NCT03784794 -
Patient Blood Management for Massive Obstetric Hemorrhage
|
N/A | |
Enrolling by invitation |
NCT06255496 -
QStat Cartridge in Obstetric Patients
|
||
Recruiting |
NCT04401839 -
Amr Maneuver for Prevention of Postpartum Hemorrhage
|
N/A | |
Recruiting |
NCT06219538 -
DAISY Uterine Drain Device Evaluation
|
N/A | |
Completed |
NCT01863706 -
Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage
|
Phase 1 | |
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 | |
Completed |
NCT03907605 -
Anti-Mullerian Hormone (AMH) is a Marker for Ovarian Reserve. There Are Many Studies About AMH Changes in Ovarian Surgery, But Little is Known for Other Surgeries. We Seek to Investigate the Hormone Variations Before and After Uterine Artey Ligation for Postpartum Hemorrage (PPH)
|