Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oxytocin | Active Comparator | The patient will be received oxytocin 20 IU by intravenous infusion |
|
| oxytocin plus misoprostol | Active Comparator | The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mc sublingual misoprostol |
|
| Carbetocin | Active Comparator | The patient will be received Carbetocin 100 mic gm IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oxytocin | Drug | The patient will be received oxytocin 20 IU by intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| The amount of blood loss | calculation of the amount of blood loss by weighing the swabs and using pictorial charts | 6 hours post delivery |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patients develop blood loss more than 1000 ml | Calculation of the number of patients develop blood loss more than 1000 ml | 24 hours post delivery |
| The number of patient need blood transfusion |
Not provided
Inclusion Criteria:
Exclusion Criteria:
All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| hany f allam, md | Aswan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University Hospital | Aswān | 81528 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33232518 | Derived | Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D010121 | Oxytocin |
| D016595 | Misoprostol |
| C020731 | carbetocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
Not provided
This study will be a prospective double-blind randomized study
Not provided
Not provided
This study will be a prospective double-blind randomized study
| oxytocin plus misoprostol | Drug | The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mic gm sublingual misoprostol |
|
|
| Carbetocin | Drug | The patient received Carbetocin 100 mic gm |
|
|
Calculation of number of patient need blood transfusion
| 24 hours post delivery |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |