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Administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta and the amount of blood loss vaginally.
Retained placenta (RP)is one of the complications of third stage of labour; it should be managed promptly as it may cause severe bleeding, infection, maternal morbidity and mortality .The current standard management of RP word wide, by manual removal aims to prevent these problems, but it is unsatisfactory method because it requires general anaesthesia in hospital, It is an invasive procedure with its own serious complications of bleeding, infection and genital tract injury. Umbilical vein injection of misoprostol is a simple, safe method and could be performed at the place of delivery .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Misoprostol | Active Comparator | 4 misoprostol tablets (Misotac® 200 micrograms tablet) dissolved in 20 ml of normal saline injected to umbilical vein |
|
| Normal saline | Placebo Comparator | Normal saline 0.9%, 20 ml was injected in the umbilical vein in cases of retained placenta |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | It is a synthetic prostaglandin (PgE1 analogue)used as a uterotonic substance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| delivery of placenta by medical intervention | The administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta under general anaesthesia. | 30 minutes after the injection of misoprostol or normal saline in the umbilical vein |
| Measure | Description | Time Frame |
|---|---|---|
| vaginal bleeding after misoprostol use | using intraumbilical misoprostol in women with retained placenta reduces the amount of blood loss vaginally. | 30 minutes after umbilical vein injection of misoprostol |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolabrity | Local applications of misoprostol through umbilical vein is associated with less side effects like shivering, fever, dizziness vomiting, flushes, nausea, abdominal pain and headache | 2 hours after umbilical vein injection of misoprostol |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shahla K. Alalaf, Clinical M.D | Hawler Medical University | Principal Investigator |
| Sheelan S Rajab, High Diploma | , Shaheed Dr.Khalid General Hospital, Directorate of Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternity Teaching Hospital | Erbil | Kurdistan Region | 383-65 | Iraq |
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| ID | Term |
|---|---|
| D018457 | Placenta, Retained |
| ID | Term |
|---|---|
| D010922 | Placenta Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Normal saline | Drug | It is a placebo group |
|
|
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |