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

Phase 3

Recruiting

• Conditions: Prevention of uterine atony after cesarean section

• Registration Number: CTRI/2011/091/000045
• Lead Sponsor: Precise Chemipharma Pvt Ltd

Brief Summary

This study is A Multicentric, Double-blind, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial of the Safety and Efficacy of Injection Carbetocin versus Injection Oxytocin in prevention of uterine atony after cesarean section that will be conducted in three centres in India

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2015-12-31

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• 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.
• •Patient’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 practice	48 hours

Secondary Outcome Measures

Name	Time	Method
Position of the fundus and tone of the uterus	48 hours

Trial Locations

Locations (8)

B.L.D.E Universitys Shri B.M.Patil Medical College Hospital and R.C.; 🇮🇳 Bijapur, KARNATAKA, India

Bhaktivedanta Hospital and Research Institute; 🇮🇳 Thane, MAHARASHTRA, India

ILS Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

J. N. Medical College Hospital, Aligarh Muslim University; 🇮🇳 Aligarh, UTTAR PRADESH, India

Lokmanya Tilak Municipal Medical College and General Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

S.D.M College of Medical Sciences and Hospital; 🇮🇳 Dharwad, KARNATAKA, India

Sanjay Gandhi Post Graduate Institute of Medical Sciences; 🇮🇳 Lucknow, UTTAR PRADESH, India

Sterling Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

B.L.D.E Universitys Shri B.M.Patil Medical College Hospital and R.C.

🇮🇳Bijapur, KARNATAKA, India

Dr Purushottam B Jaju

Principal investigator

9845241315

pbjaju@gmail.com