TO ASSESS TO UTEROSTONIC EFFECTS OF CARBETOCIN VERSUS OXYTOCIN IN A CESAREAN SECTION WITH A HIGH RISK OF POST PARTUM HEMORRHAGE
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 188
- Locations
- 1
- Primary Endpoint
- Uterotonic effect: post partum hemorrheage rate (i.e. number of women who experience postpartunm hemorrhage even after drug administration ) after drug administration
Study Overview
Brief Summary
a prospective comparative observational study To Assess The Uterotonic Effects Of Carbetocin Versus Oxytocin In A Cesarean Section With A High Risk Of Postpartum Hemorrhage in 188 patients. participants will be consecutively allocated into two groups based on the uterotonic agent received: Group A(UNIT IIIA- UNDER DR NAMITA DOHAREY) will consist of women who will be administered 100 µg of intravenous carbetocin as a single bolus at the delivery of the anterior shoulder, while Group B(UNIT IIIB- UNDER DR VISHI) will include women who will receive 20 IU of oxytocin diluted in 1000 mL of 0.9% sodium chloride solution, infused at a rate of 150 mL per hour starting at the same time point. primary outcome will be to measure post partum hemorrheage rate (i.e. number of women who experience postpartunm hemorrhage even after drug administration ) after drug administration and secondary outcomes will be Hemodynamic Effects: Changes in systolic and diastolic blood pressure at: Baseline (after CSE anesthesia), 1, 3, and 5, 10 and 60 minutes after drug administration, Estimated Blood Loss: Intraoperative and immediate postoperative blood loss estimation, Need for Additional Uterotonics: Proportion of women requiring additional uterotonic agents (e.g., methylergometrine, misoprost, carboprost), Hemoglobin Drop: Change in hemoglobin levels: Preoperative, 2 hours postoperative, 24 hours postoperative and Adverse Effects: Incidence of Postop Nausea and Vomiting, Flushing, Headache, Dyspnea
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- ••Women scheduled for cesarean section who are willing to participate.
- ••Presence of maternal risk factors for PPH, such as: 1- Multifetal pregnancy 2- Previous cesarean section 3- Elderly gravida 4- Multiparpus female 5-Uterine fibroids, myomectomy history, or placenta previa, placenta accreta spectrum 6-Past history of postpartum hemorrhage 7-Presence of fetal risk factors, including macrosomia or polyhydramnios-associated malformations.(related with uterine overdistension) 8-IVF conceived pregnancy •Hypertension or preeclampsia.
Exclusion Criteria
- •Women giving negative consent to participate in study •women with Cardiac, renal, or hepatic disease •Epilepsy •Hypersensitivity to carbetocin (as per British National Formulary) •Undergo general anesthesia for the cesarean section.
Outcomes
Primary Outcomes
Uterotonic effect: post partum hemorrheage rate (i.e. number of women who experience postpartunm hemorrhage even after drug administration ) after drug administration
Time Frame: Uterotonic effect: post partum hemorrheage rate (i.e. number of women who experience postpartunm hemorrhage even after drug administration ) after drug administration
Secondary Outcomes
- 1. Hemodynamic Effects: Changes in systolic & diastolic blood pressure at: Baseline (after CSE anesthesia), 1, 3, & 5, 10 & 60 minutes after drug administration,
- estimated Blood Loss: Intraoperative & immediate postoperative blood loss estimation
- Need for Additional Uterotonics: Proportion of women requiring additional uterotonic agents (e.g., methylergometrine, misoprost, carboprost)
- Hemoglobin Drop: Change in hemoglobin levels: Preoperative, 2 hours postoperative, 24 hours postoperative
- Adverse Effects: Incidence of Postop Nausea and Vomiting, Flushing, Headache, Dyspnea
Investigators
DR GAURI GOYAL
DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES