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
| Name | Class |
|---|---|
| Centro Rosarino de Estudios Perinatales (CREP) | UNKNOWN |
This double-blind, randomized controlled trial will evaluate the effect of the route of administration of 10 IU of oxytocin on the average blood loss postpartum. Participants will be randomized to receive 10 IU of oxytocin by IV infusion or 10 IU of oxytocin by injection IM
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Infusion | Active Comparator | Oxytocin 10 IU, 500 ml IV infusion within 40 minutes + intra muscular injection of placebo, 10 IU |
|
| IM administration | Active Comparator | Oxytocin 10 IU via intra muscular injection + Intravenously administered placebo, 10 IU, 500ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Oxytocin + IM placebo | Drug |
| ||
| IM Oxytocin + IV placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of blood loss (mL) | 1 hour postpartum | |
| Proportion of women who had postpartum blood loss ≥500 ml | 1 hour postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of women who had postpartum blood loss ≥1000 ml | 1 hour postpartum | |
| Average change in hemoglobin level | pre-delivery and at least 24 hours postpartum | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Ilana Dzuba, MPH | Gynuity Health Projects | Principal Investigator |
| Guillermo Carroli, MD | Centro Rosarino de Estudios Perinatales (CREP) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital J.R. Vidal | Corrientes | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33169839 | Derived | Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4. |
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 |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Average time required until expulsion of the placenta |
| 1 hour postpartum |
| Proportion who needed additional Interventions | Through study completion, an average of 24-48 hours postpartum |
| Side effects | 1 hour postpartum |
| Blood pressure | 15, 30, 45 and 60 minutes postpartum |
| Heart rate | 15, 30, 45 and 60 minutes postpartum |
| 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 |