A clinical trial to study the effects of Carbetocin Injection in prevention of uterine atony after cesarean sectio

Phase 3

Recruiting

Conditions: Health Condition 1: null- Prevention of uterine atony after cesarean section

Registration Number: CTRI/2011/091/000045

Lead Sponsor: Precise Chemipharma Pvt Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 200

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

•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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures