Post Partum Hemorrhage Clinical Trial
Official title:
Intrauterine Misoprostol Versus Intravenous Oxytocin Infusion During Cesarean Delivery to Reduce Intraoperative and Postoperative Blood Loss: A Randomized Clinical Trial.
NCT number | NCT03148574 |
Other study ID # | IUM |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | July 2, 2017 |
Est. completion date | December 15, 2019 |
Verified date | April 2021 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Bleeding is still the major cause of mortality and morbidity in postpartum period. World health organization has reported 585000 deaths for pregnancy each year. Twenty five percent of cases die from post-partum bleeding. Mean amount of blood lost is 500 ml during normal vaginal delivery, 1000 ml in cesarean section, and 3500 ml during cesarean section with emergency hysterectomy
Status | Completed |
Enrollment | 240 |
Est. completion date | December 15, 2019 |
Est. primary completion date | September 15, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: 1-Uncomplicated pregnancy, 2-Had no hypersensitivity or contraindications to prostaglandins. 3-Had no history of coagulopathy. 4-Accepting to participate in the study. Exclusion Criteria: \1-women with anemia (Haemoglobin <8 gram ). 2 placental abnormality (e.g placenta previa,placenta abruption ) 3. History of complications at previous pregnancy especially postpartum hemorrhage. 4- Maternal hypertension , current or previous history of heart disease ,liver ,Renal disorders or known coagulopathy |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut Faculty of Medicine | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | amount of intraoperative blood loss | 30 minutes |
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