Placenta Previa Without Hemorrhage Clinical Trial
Official title:
Uterine Artery Ligation to Minimize Blood Loss in Patients With Central Placenta Previa
| Verified date | March 2016 |
| Source | Minia Maternity University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Egypt: Ministry of Higher Education |
| Study type | Interventional |
This trial will address the effect of uterine artery ligation during Cesarean section in cases with placenta previa to decrease blood loss.
| Status | Completed |
| Enrollment | 52 |
| Est. completion date | November 2014 |
| Est. primary completion date | November 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 49 Years |
| Eligibility |
Inclusion Criteria: - Placenta previa is diagnosed when the lowest placental edge is located within 5 cm of the internal os at ultrasound - Symptomatic Placenta previa with at least one episode of bleeding - Estimated gestational age within 28 to 40 weeks - Maternal age > 18 years - Informed consent - Social affiliation Exclusion Criteria: - Premature rupture of membranes - Severe bleeding. - Abnormal fetal heart rates. - Pre-eclampsia, chorioamnionitis, severe chronic renal disease. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Minia Maternity University Hospital | Minia |
| Lead Sponsor | Collaborator |
|---|---|
| Minia Maternity University Hospital |
Egypt,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in hemoglobin level | Changes in hemoglobin level before and after CS will reflect the amount of blood loss during operation | hemoglobin level will be done baseline and will be repeated 24 hours after delivery | Yes |
| Secondary | Degree of uterine contractility. | During CS and within 3 hours after CS | Yes |