Postpartum Hemorrhage
Conditions
Keywords
Postpartum Hemorrhage, vaginal delivery, carbetocin, misoprostol, oxytocin
Brief 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.
Detailed description
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
DRUGoxytocin
The patient will be received oxytocin 20 IU by intravenous infusion
DRUGoxytocin plus misoprostol
The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mic gm sublingual misoprostol
DRUGCarbetocin
The patient received Carbetocin 100 mic gm
Sponsors
Aswan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This study will be a prospective double-blind randomized study
Intervention model description
This study will be a prospective double-blind randomized study
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The amount of blood loss | 6 hours post delivery | calculation of the amount of blood loss by weighing the swabs and using pictorial charts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of patients develop blood loss more than 1000 ml | 24 hours post delivery | Calculation of the number of patients develop blood loss more than 1000 ml |
| The number of patient need blood transfusion | 24 hours post delivery | Calculation of number of patient need blood transfusion |
Countries
Egypt
Outcome results
None listed