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The aim of the work is to evaluate & compare the effectiveness of rectally administered PGE1 synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol before caesarean section to decrease blood loss during and after the operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sublingual misoprostol & rectal placebo | Experimental | will receive 400 microgram of misoprostol (Sigma) sublingual "2 tablets" and rectal placebo"2 tablets". |
|
| rectal & sublingual placebo | Placebo Comparator | will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets". |
|
| rectal misoprostol & sublingual placebo | Experimental | will receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets". |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | Comparison of different routes of administration of 400 micro gram misoprostol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative Blood Loss | from start of cesarean section till the end of operation (average one hour) |
| Measure | Description | Time Frame |
|---|---|---|
| Need for Extra Ecbolics (Oxytocin). | from start of cesarean section till the end of operation (average one hour) | |
| APGAR Score | The Apgar score is the first test given to a newborn, it is referred to as an acronym for: Appearance, Pulse, Grimace, Activity, and Respiration. Scores obtainable are between 10 and 0, with 10 being the highest possible score. Pulse: above 100 beats per minute (2), below 100 beats per minute (1), absent (0). Respiration: Normal rate and effort, good cry (2), Slow or irregular,weak cry (1), absent (0). Grimace: Pulls away, sneezes, coughs, or cries with stimulation (2), Facial movement only (1), absent (0). Activity: Active, spontaneous movement (2), Arms and legs flexed with little movement (1), absent (0). Appearance: Normal color (2), Normal color (but hands and feet are bluish) (1), Bluish-gray or pale all over (0). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin Concentration | 24 hours postoperative from baseline hemoglobin | |
| Change in Hematocrite Value | 24 hours postoperative from baseline hematocrite value |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed S. Sweed, MD | Ain Shams University | Principal Investigator |
| Mourad M. El-Said, Professor | AinShams University | Study Director |
| Amgad E. Abou-Gamrah, Ass.Prof. | AinShams university | Study Director |
| Haitham El-Sabe, MD | AinShams University | Study Director |
| Mohamed M. AbdEl-Hamid, Registrar | AinShams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Maternity Hospital | Cairo | Egypt |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sublingual Misoprostol & Rectal Placebo | will receive 400 microgram of misoprostol (Sigma) sublingual "2 tablets" and rectal placebo"2 tablets". Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol |
| FG001 | Rectal & Sublingual Placebo | will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets". |
| FG002 | Rectal Misoprostol & Sublingual Placebo | will receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets". Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sublingual Misoprostol & Rectal Placebo | will receive 400 microgram of misoprostol (Sigma) sublingual "2 tablets" and rectal placebo"2 tablets". Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol |
| BG001 | Rectal & Sublingual Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intraoperative Blood Loss | Posted | Mean | Standard Deviation | millilitres | from start of cesarean section till the end of operation (average one hour) |
|
starting intra-operative till one week postoperative (time of checking the wound)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sublingual Misoprostol & Rectal Placebo | will receive 400 microgram of misoprostol (Sigma) sublingual "2 tablets" and rectal placebo"2 tablets". Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mohamed S. Sweed, Dr.Mourad M.El-Said, Dr.Amgad E. Abou-Gamrah, Dr.Mohamed M. Abd-El-Hamid | AinShams University | 01001222047 | +2 | drmsweed@gmail.com |
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| ID | Term |
|---|---|
| D006473 | Postpartum 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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|
| Placebo | Other |
|
| 1minute and 5 minutes from delivery of the fetus |
| Time to Resume Bowel Habits | average 24 hours |
| Need for Extra Analgesics | average 24 hours |
| Need for Postoperative Blood Transfusion | average 24 hours |
| Incidence of Wound Sepsis | upto one week |
| Incidence of Adverse Effects | 24 hours |
will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets". |
| BG002 | Rectal Misoprostol & Sublingual Placebo | will receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets". Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | Kg/m2 |
|
| Parity | Median | Inter-Quartile Range | Births |
|
| Gestational Age | Mean | Standard Deviation | Weeks |
|
will receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets". Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol |
|
|
| Secondary | Need for Extra Ecbolics (Oxytocin). | Posted | Number | participants | from start of cesarean section till the end of operation (average one hour) |
|
|
|
| Other Pre-specified | Change in Hemoglobin Concentration | Posted | Mean | Standard Deviation | gram/dL | 24 hours postoperative from baseline hemoglobin |
|
|
|
| Secondary | APGAR Score | The Apgar score is the first test given to a newborn, it is referred to as an acronym for: Appearance, Pulse, Grimace, Activity, and Respiration. Scores obtainable are between 10 and 0, with 10 being the highest possible score. Pulse: above 100 beats per minute (2), below 100 beats per minute (1), absent (0). Respiration: Normal rate and effort, good cry (2), Slow or irregular,weak cry (1), absent (0). Grimace: Pulls away, sneezes, coughs, or cries with stimulation (2), Facial movement only (1), absent (0). Activity: Active, spontaneous movement (2), Arms and legs flexed with little movement (1), absent (0). Appearance: Normal color (2), Normal color (but hands and feet are bluish) (1), Bluish-gray or pale all over (0). | Posted | Mean | Standard Deviation | units on a scale | 1minute and 5 minutes from delivery of the fetus |
|
|
|
| Secondary | Time to Resume Bowel Habits | Posted | Mean | Standard Deviation | hours | average 24 hours |
|
|
|
| Secondary | Need for Extra Analgesics | Posted | Number | participants | average 24 hours |
|
|
|
| Secondary | Need for Postoperative Blood Transfusion | Posted | Number | participants | average 24 hours |
|
|
|
| Secondary | Incidence of Wound Sepsis | Posted | Number | no. of cases experiencing wound sepsis | upto one week |
|
|
|
| Secondary | Incidence of Adverse Effects | Posted | Number | no. of cases experiencing side effects | 24 hours |
|
|
|
| Other Pre-specified | Change in Hematocrite Value | Posted | Mean | Standard Deviation | Percentage Hematocrit | 24 hours postoperative from baseline hematocrite value |
|
|
|
| 0 |
| 212 |
| 44 |
| 212 |
| EG001 | Rectal & Sublingual Placebo | will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets". | 0 | 212 | 11 | 212 |
| EG002 | Rectal Misoprostol & Sublingual Placebo | will receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets". Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol | 0 | 212 | 26 | 212 |
| wound sepsis | Infections and infestations | Systematic Assessment |
|
| Chills | General disorders | Systematic Assessment |
|
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| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
|
| Title | Measurements |
|---|---|
|