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| Name | Class |
|---|---|
| Center for Research and Consultancy in Reproductive Health | OTHER |
| Hung Vuong Hospital | OTHER |
| MOH Etlik Zubeyde Hanim Women's Health Training and Research Hospital | UNKNOWN |
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The study will evaluate whether prophylactic oxytocin administered in the third stage of labor via IV infusion results in a lower mean blood loss compared to IM injection.
The study will compare the effect of IV infusion and IM oxytocin administration on the proportion of women who experience blood loss greater than or equal t 350 ml, the proportion of women who experience blood loss greater than or equal to 500 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery. It will also assess whether a bleeding history questionnaire can identify women at risk for excessive bleeding and help to define the distribution of bleeding scores among women with and without excessive bleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV infusion | Active Comparator | Oxytocin 10 IU will be administered IV infusion according to randomization assignment as soon as possible after delivery of the baby. |
|
| IM Injection | Active Comparator | Oxytocin 10 IU will be administered IM according to randomization assignment as soon as possible after delivery of the baby. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | 10 IU oxytocin in 500 ml infusion |
| |
| Oxytocin |
| Measure | Description | Time Frame |
|---|---|---|
| Mean blood loss (ml) | minimum of 1 hour after delivery of baby |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of women who bleed greater or equal to 350 ml, 500 ml and 1000 ml | minimum of 1 hour after delivery of baby | |
| Change in hemoglobin from pre-delivery to postpartum | Post-delivery hemoglobin using a Hemocue® Hemoglobin machine + cuvette will be taken at least 24 after delivery and before the woman leaves the facility. If the woman has received IV fluids, hemoglobin will be measured at least 12 hours after removal of the IV prior to discharge. |
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Inclusion Criteria:
Exclusion Criteria: Women who are:
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| Name | Affiliation | Role |
|---|---|---|
| Beverly Winikoff, MD, MPH | Gynuity Health Projects | Principal Investigator |
| Ilana Dzuba, MHS | Gynuity Health Projects | Principal Investigator |
| Jill Durocher | Gynuity Health Projects | Principal Investigator |
| Jennifer Blum, MPH | Gynuity Health Projects | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Gineco-Obstétrico Isidro Ayora | Quito | Ecuador | ||||
| SB Etlik Zübeyde Hanım Kadın Hastalıkları Eğitim ve Araştırma Hastanesi |
| 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. |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| Drug |
10 IU oxytocin IM injection |
|
| 12-24 hours after delivery |
| Time to placental delivery | minimum of 1 hour after delivery of baby |
| Administration of additional oxytocin, other uterotonics, or other interventions such as blood transfusion and hysterectomy | minimum of 1 hour after delivery of baby |
| Side effects 1 hour postpartum | 1 hour postpartum |
| Bleeding scores calculated from a standardized questionnaire administered on arrival to labor ward | arrival to labor ward |
| Ankara |
| Turkey (Türkiye) |
| Huong Vuong Hospital | Ho Chi Minh City | Vietnam |
| 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 |