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This study evaluates intra umbilical vein injection of 800 µg versus 400 µg misoprostol for the treatment of retained placenta to reduce the need of manual removal of placenta under general anaesthesia
The third stage of labor may be complicated by retained placenta, which may cause severe bleeding and infection, with a potentially fatal outcome. Manual removal of placenta is the current standard of management of retained placenta which usually requires general or regional anaesthesia at a hospital and it is an invasive procedure that may lead to bleeding, trauma and infection. Intraumbilical injection of uterotonic agent( misoprostol) is an easy, non invasive procedure. A randomized clinical trial are required to determine the difference between two doses of misoprostol 400 versus 800 micro gram for management of retained placenta
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 400 Microgram Misoprostol | Active Comparator | Misoprostol 400 micro-gram dissolved in 20 mL normal saline will be injected in the umbilical vein in the first group |
|
| 800 Microgram Misoprostol | Active Comparator | Misoprostol 800 micro-gram dissolved in 20 mL normal saline will be injected in umbilical cord of the second group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | 2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women |
|
| Measure | Description | Time Frame |
|---|---|---|
| Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol | complete delivery of placenta after injection of intraumbilical misoprostol | up to 30 minutes after intraumbilical injection |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of blood loss vaginally in both groups | To estimate the amount of vaginal blood loss from time of injection of the the interventional drug and till the delivery of the placenta | up to 30 minutes after injection of placenta |
| The time of delivery of placenta in both groups |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shahla K. Alalaf, professor | Hawler Medical University | Principal Investigator |
| Namir G. Al Tawil, Professor | Hawler Medical University | Study Director |
| Ariana Kh. Jawad, Assistant professor | KBMS | Study Chair |
| Bahar Q. Muhammad, CABOG | Maternity Teaching Hospital | Study Chair |
| Jinan N. Hassan, IBMS | Duhok university | Study Chair |
| Salim A. Salim, Master | Al-Azhar University | Study Chair |
| Khalida M. Ameen, CABOG | Karkuk Medical college | Study Chair |
| Maryam B. Mahmood, FICOG | Sulaimani Maternity Hospital | Study Chair |
| Khansa H. Abdul Rahman, MBChB | Maternity Teaching Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hawler Medical university | Erbil | Kurdistan Region | 44001 | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33705565 | Derived | Kumar N, Jahanfar S, Haas DM, Weeks AD. Umbilical vein injection for management of retained placenta. Cochrane Database Syst Rev. 2021 Mar 11;3(3):CD001337. doi: 10.1002/14651858.CD001337.pub3. |
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| ID | Term |
|---|---|
| D006473 | Postpartum Hemorrhage |
| D018457 | Placenta, Retained |
| D006470 | 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 |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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|
the time interval estimation from the injection to complete delivery of the placenta |
| up to 30 minutes after delivery of the placenta |
| side effects of misoprostol | Any side effects related to misoprostol after the injection (Fever, severing , diarrhea) | up to 24 hours after delivery of placenta |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010922 | Placenta Diseases |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |