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| Name | Class |
|---|---|
| Cipla Ltd. | INDUSTRY |
| AstraZeneca | INDUSTRY |
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Sublingual misoprostol produces rapid peak concentration and is more effective than oral misoprostol for prevention of excessive postpartum bleeding. The study hypothesis was to test whether women receiving sublingual misoprostol for prevention of postpartum hemorrhage have 30 ml less average blood loss than women receiving oxytocin, the standard of care for prevention of postpartum hemorrhage. We conducted a Double blind randomized controlled trial of .652 consenting, eligible pregnant women admitted to the labor room of the teaching hospital at J N Medical College, Belgaum, India. Women participating in the study were assigned by computer generated randomization to receive the study medications and placebos within one minute after clamping and cutting the umbilical cord. We also looked at the drugs effects on postpartum blood loss at or above ≥500 ml (considered hemorrhage), and the percent of women experiencing more than a 10% decline in haemoglobin, and reported drug side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sublingual misoprostol | Experimental | 400 µg powdered misoprostol administered sublingually; IM placebo |
|
| Oxytocin | Active Comparator | 10 IU IM oxytocin; placebo powder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | 400 µg sublingual misoprostol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| mean blood loss | Blood loss was objectively measured using the BRASSS-V DrapeTM, placed under the buttock before the delivery. The calibrated blood collection receptacle was opened after the delivery and drainage of amniotic fluid. Blood collected in the drape was transferred to measuring jar with 10 ml calibrations for accuracy. Blood soaked swabs were weighed in grams, and the known dry weight of the swabs was subtracted; this volume was added to the drape's measured blood volume (assuming 1 gm equivalence with 1 ml). | 2 hours after delivery |
| postpartum hemorrhage (Blood loss >500 mls) | Blood loss was objectively measured using the BRASSS-V DrapeTM, placed under the buttock before the delivery. The calibrated blood collection receptacle was opened after the delivery and drainage of amniotic fluid. Blood collected in the drape was transferred to measuring jar with 10 ml calibrations for accuracy. Blood soaked swabs were weighed in grams, and the known dry weight of the swabs was subtracted; this volume was added to the drape's measured blood volume (assuming 1 gm equivalence with 1 ml). | 2 hours after delivery |
| Measure | Description | Time Frame |
|---|---|---|
| The percent of women experiencing a ≥10% postpartum decline in haemoglobin | Hemoglobin was obtained at presentation for delivery and again between 12 and 48 hours after delivery. | At presentation for delivery and 12-48 hours after delivery |
| Medication side effects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M B Bellad, M.D. | Jawaharlal Nehru Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jawaharlal Nehru Medical College | Belagavi | Karnataka | 590010 | India |
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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 |
|---|---|
| D016595 | Misoprostol |
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Oxytocin |
| Drug |
10 IU IM |
|
Self reported side effects including nausea, vomiting, diarrhoea, abdominal pain, shivering and elevated temperature |
| 2 hours after delivery |
| 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 |