Comparison of the efficacy of oxtyocin agonist to oxytocin in the prevention of postpartum hemorrhage (PPH) in women undergoing vaginal delivery

Phase 3

Active, not recruiting

• Conditions: Postpartum Hemorrhage; vaginal delivery; vaginal delivery and blood loss; Reproductive Health and Childbirth - Childbirth and postnatal care

• Registration Number: ACTRN12608000396325
• Lead Sponsor: Dr Farouk

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-05
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 720

Inclusion Criteria

Normal and healthy women who will undergo vaginal delivery, Parity I-IV, Singleton pregnancy with cephalic presentation

Exclusion Criteria

Primigravida or Para V and above, History of PPH and/or uterine atony in the previous delivery, History of cardiac arrhythmia or any other clinically significant heart diseases, History of hypertension requiring treatment within the last 2 years, History of anaemia (Hb <10 g/dL), Known or suspected coagulopathy (hereditary or acquired) (eg. von Willebrand’s disease, etc), History or evidence of chronic liver, renal or endocrine disease, History of hypersensitivity to oxytocin or carbetocin, Placenta previa or abruptio placentae, Any sign of pre-existing uterine pathology or anomaly, Rupture of membrane

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Requirement for additional intervention (including use of additional oxytocics or uterine massage etc.). Additional intervention can be used any point of time by ongoing assessments of uterine tone, bleeding and other vital signs.dditional intervention[24 hours postpartum]

Secondary Outcome Measures

Name	Time	Method
Hemoglobin concentration at the establishment of labour and at the 1st 24hrs after vaginal delivery by blood test[24 hours after delivery];Measure changes in uterine tone, blood pressure or pulse before and after study drug administration[24 hours after vaginal delivery];Safety profiles of the study drugs by recording all side effects or adverse events should they occur. Adverse events associated with oxytocin or carbetocin may be nausea, abdominal pain, pruritis, flushing, vomiting etc, infrequent adverse events include back pain, dizziness, metallic taste, anaemia, sweating etc., any above signs of possible adverse events would be recorded in the case report form (CRF) accordingly in both delivery and recovery rooms[prior to discharge];Blood loss: estimated total volume of blood loss over 24h was measured by weighing all sanitary napkins and disposable bedding sheets used in delivery and then subtracting the original weight of each item[24 hours after delivery]