DRUG
oxytocin
The patient will be received oxytocin 20 IU by intravenous infusion
Status
Completed
Phase
Not applicable
Enrollment
135
Locations
1
Results
Not posted
Publications
1
Study summary
The objective of this study is to compare the effectiveness and safety of carbetocin vs. oxytocin plus sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH)after vaginal delivery.
The first cause of hemorrhage at the time of delivery is uterine atony; therefore, there is general agreement that active management of the third stage of labor is recommended. Oxytocin is the most widely used uterotonic agent but has a half-life of only 4-10 min, that is why it is better administered as a continuous intravenous infusion to achieve sustained uterotonic activity. Carbetocin is a synthetic long-acting oxytocin agonistic analog with prolonged half-life prolonging its pharmacological effects. Its prolonged uterine activity may theoretically offer advantages over oxytocin in the management of the third stage of labor. The side-effect profile of carbetocin was not found to be different from that of Oxytocin but may prove to be advantageous when compared to Syntometrine.
Interventions
DRUG
The patient will be received oxytocin 20 IU by intravenous infusion
DRUG
The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mic gm sublingual misoprostol
DRUG
The patient received Carbetocin 100 mic gm
Timeline
First posted
Mar 12, 2019
Study start
Apr 1, 2019
Primary completion
Jun 30, 2021
Study completion
Aug 1, 2021
Results posted
Not reported
Registry updated
Sep 29, 2021
Outcomes
The amount of blood loss
Time frame · 6 hours post delivery
calculation of the amount of blood loss by weighing the swabs and using pictorial charts
The number of patients develop blood loss more than 1000 ml
Time frame · 24 hours post delivery
Calculation of the number of patients develop blood loss more than 1000 ml
The number of patient need blood transfusion
Time frame · 24 hours post delivery
Calculation of number of patient need blood transfusion
Eligibility
Inclusion Criteria: * All participants had PPH defined as vaginal bleeding\>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation Exclusion Criteria: * gestational age\<37 weeks, * genital tract trauma, * coagulation defect, * women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy * known hypersensitivity to carbetocin or oxytocin.
Study locations
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Aswan University Hospital
Aswān, Egypt
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