Health Condition 1: null- Prevention of uterine atony after cesarean section
Conditions
Interventions
Intervention1: Carbetocin Injection: For patients in the carbetocin group dose 1 will be 100 µg of carbetocin, and dose 2 will be 2 mL of normal saline solution.
Control Intervention1: Oxytocin injec
Sponsors
Precise Chemipharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • All subjects with duly filled and signed in ICFs [Informed Consent Forms] • Female patients >18 years of age with confirmed pregnancy reports and planned for cesarean section through a lower-segment transverse incision under regional anesthesia • In generally good health • Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved Informed Consent Form
Exclusion criteria
Exclusion criteria: • Patients unwilling to sign on ICF • Known hypersensitivity to study drugs • Diagnosed placenta previa or abruptio placentae • Use of general anesthesia • Classic uterine incision for cesarean section • Previous history of uterine atony and postpartum bleeding • Twin gestation • Number of previous cesarean sections • Grand multiparity ( >5 previous deliveries). • A current or previous history of significant disease including heart disease • Chronic hypertension requiring treatment • Liver, renal, or endocrine disorders (other than gestational diabetes) • History or currently consuming abusing drugs or alcohol • History of coagulopathy . • Patients with abnormal clinical chemistry, hematology, urinalysis, or ECG test results that are considered clinically significant by the investigator or the sponsor. • Patientâ??s known to be positive for Hepatitis B, Hepatitis C, HIV-1 or HIV-2. • Patients being treated with any of the excluded medications mentioned in the protocol. • Participation in other trials or Previous participation in this or any other carbetocin clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is defined by the need for additional Oxytocic intervention in the 48 hours after delivery to maintain the uterus well contracted, as judged by the investigator, as would be done under usual clinical practiceTimepoint: 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| ï?§ Position of the fundus and tone of the uterusTimepoint: 48 hours | — |
Countries
India
Contacts
Public ContactDr Manjusha Patankar
Clinical Medicine Infomatics India Pvt. Ltd.
Outcome results
None listed