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Bemiparin for pregnant women with abnormal umbilical artery Doppler ultrasound
152 women with history of unexplained stillbirths were identified , umbilical arty Doppler ultrasound was conducted for them at 20-22 weeks gestation . they were divided into two group , group one are those with abnormal resistant index (= or more than 0.6) thy received Bemiparin 2500 IU subcutaneously daily up to 24 hours before delivery .
Group 2 with normal umbilical artery resistant index received no any interventions just routine antenatal follow up .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bemiparin group | Active Comparator | Women with high resistant index of umbilical artery received the intervention Bemiparin Sodium 2,500 IU anti Xa/0.2 ml solution for injection in pre-filled syringe provided for each woman . The injections were received daily since 20 weeks gestation and up to 24 hours before delivery Other Name: Hibor; Laboratories Rovi pharmaceuticals |
|
| control group | Placebo Comparator | Normal umbilical arty resistant index group received only multivitamins and routine antenatal follow up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bemiparin | Drug | second generation low molecular weight Heparin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stillbirth | Intrauterine fetal death | after 20 weeks gestation to the delivery of fetus |
| Early neonatal death | Death of newborn | First week of life |
| Low birth weight | New borne with birth weight less than 5th percentile in kilogram | first hour of life |
| Measure | Description | Time Frame |
|---|---|---|
| Preterm labor | delivery of the fetus before 37 weeks gestation | 20-37 weeks |
| Pre-eclampsia | High blood pressure with protein urea | 20-41 week gestation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| shahla k. Alalaf, M.D | Hawler Medical University, college of Medicine, department of Obstetrics and Gynecology | Principal Investigator |
| Ariana K. Jawad, CABOG | Kurdistan Board for Medical Specialist | Study Director |
| Mahabad S. Ali, Diploma | Maternity Teaching Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hawler Medical University | Erbil | Kurdistan Region | 44001 | Iraq |
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| ID | Term |
|---|---|
| C411345 | bemiparin |
| C067316 | Geritol |
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pregnant women with history of unexplained fetal death
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| multivitamins and routine antenatal follow up | Other | multivitamins and routine antenatal follow up |
|
| major abruptio placenta | Antepartum hemorrhage | 20-41 week gestation |