Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: carbetocin: 100 µg of intravenous carbetocin as a single bolus at the delivery of the anterior shoulder
Control Intervention1: oxytocin: 20 IU of oxytocin dilute
Sponsors
DR GAURI GOYAL
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uterotonic effect: post partum hemorrheage rate (i.e. number of women who experience postpartunm hemorrhage even after drug administration ) after drug administrationTimepoint: Uterotonic effect: post partum hemorrheage rate (i.e. number of women who experience postpartunm hemorrhage even after drug administration ) after drug administration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hemodynamic Effects: Changes in systolic & diastolic blood pressure at: Baseline (after CSE anesthesia), 1, 3, & 5, 10 & 60 minutes after drug administration, Timepoint: 1 hour;estimated Blood Loss: Intraoperative & immediate postoperative blood loss estimation Timepoint: 1 day;Need for Additional Uterotonics: Proportion of women requiring additional uterotonic agents (e.g., methylergometrine, misoprost, carboprost) Timepoint: ;Hemoglobin Drop: Change in hemoglobin levels: Preoperative, 2 hours postoperative, 24 hours postoperative Timepoint: 1 day;Adverse Effects: Incidence of Postop Nausea and Vomiting, Flushing, Headache, Dyspnea Timepoint: | — |
Countries
India
Contacts
Public ContactDR GAURI GOYAL
DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES
Outcome results
None listed