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
This prospective randomized double-blind clinical trial will be conducted at Ain-Shams University Maternity Hospital, Cairo, Egypt. Patients eligible for elective lower segment cesarean section will be randomized to 2 groups. Group 1: will receive 400 ug misoprostol following + 10 IU oxytocin intravenous slowly after cord clamping. Group 2: will receive 100 ug carbetocin intravenous after cord clamping.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol + Oxytocin | Active Comparator | 400 ug sublingual misoprostol + 10 IU Oxytocin IVI |
|
| Carbetocin | Active Comparator | 100 ug Carbetocin IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug |
|
| |
| Oxytocin |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of post-partum hemorrhage | 24 hours | |
| amount of blood loss | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants needing extra uterotonic drug (10 IU oxytocin IVI) | An experienced attendant (principal investigator) will assess the need of extra uterotonic drug (10 IU oxytocin IVI) if the uterus is atonic or if blood loss is more than 1000 ml. | 24 hours |
| Number of participants needing hemostatic surgical interventions |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Maternity Hospital | Cairo | Egypt |
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 |
|---|---|
| D016595 | Misoprostol |
| D010121 | Oxytocin |
| C020731 | carbetocin |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
|
|
| Carbetocin | Drug |
|
|
| Placebo | Drug |
|
| intra-operative |
| Hemoglobin deficit in gm/dl | difference between pre-operative and 24 hours post-operative hemoglobin in gm/dl | 24 hours |
| APGAR score at 1 minute and 5 minutes | 1 minute and 5 minutes |
| Number of participants with NICU admission | 24 hours |
| Drug side effects | 24 hours |
| Time till resuming bowel habits | Time of passing gas will be recorded how many hours post-operative | 24 hours |
| hematocrit deficit in % | difference between pre-operative and 24 hours post-operative hematocrit in % | 24 hours |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |