Postpartum Hemorrhage
Conditions
Keywords
Postpartum hemorrhage, Intrapartum blood loss, Misoprostol
Brief summary
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.
Interventions
DRUGMisoprostol
Comparison of different routes of administration of 400 micro gram misoprostol
OTHERPlacebo
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients booked for elective cesarean section. 2. Singleton pregnancies. 3- Full term pregnancies (GA 37-42 weeks). 4- Patients with only previous one cesarian section
Exclusion criteria
1. Primigravida. 2. Blood dyscrasias. 3. Large fibroids. 4. Multiple pregnancies. 5. Overdistended uterus eg. Hydramnios. 6. Pre-eclampsia. 7. Marked maternal anemia (Preoperative hemoglobin \< 9 gm/dl). 8. Previous history of PPH. 9. Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol. 10. Placenta previa. 11. Contraindication to spinal anesthesia. 12. Previous myomectomy. 13. Previous two or more C.S.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative Blood Loss | from start of cesarean section till the end of operation (average one hour) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for Extra Ecbolics (Oxytocin). | from start of cesarean section till the end of operation (average one hour) | — |
| APGAR Score | 1minute and 5 minutes from delivery of the fetus | 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). |
| Time to Resume Bowel Habits | average 24 hours | — |
| Need for Extra Analgesics | average 24 hours | — |
| Incidence of Wound Sepsis | upto one week | — |
| Incidence of Adverse Effects | 24 hours | — |
| Need for Postoperative Blood Transfusion | average 24 hours | — |
Other
| Measure | Time frame |
|---|---|
| Change in Hemoglobin Concentration | 24 hours postoperative from baseline hemoglobin |
| Change in Hematocrite Value | 24 hours postoperative from baseline hematocrite value |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sublingual Misoprostol & Rectal Placebo will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol | 212 |
| Rectal & Sublingual Placebo will receive rectal placebo2 tablets and sublingual placebo2 tablets. | 212 |
| Rectal Misoprostol & Sublingual Placebo will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.
Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol | 212 |
| Total | 636 |
Baseline characteristics
| Characteristic | Sublingual Misoprostol & Rectal Placebo | Rectal & Sublingual Placebo | Rectal Misoprostol & Sublingual Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 26.9 years STANDARD_DEVIATION 2.6 | 26.4 years STANDARD_DEVIATION 2.7 | 26.5 years STANDARD_DEVIATION 2.5 | 26.6 years STANDARD_DEVIATION 2.6 |
| Body Mass Index (BMI) | 27.5 Kg/m2 STANDARD_DEVIATION 1.7 | 27.6 Kg/m2 STANDARD_DEVIATION 1.9 | 27.4 Kg/m2 STANDARD_DEVIATION 1.7 | 27.5 Kg/m2 STANDARD_DEVIATION 1.76 |
| Gestational Age | 38.9 Weeks STANDARD_DEVIATION 1 | 38.9 Weeks STANDARD_DEVIATION 0.9 | 38.8 Weeks STANDARD_DEVIATION 0.9 | 38.8 Weeks STANDARD_DEVIATION 0.9 |
| Parity | 1 Births | 1 Births | 1 Births | 1 Births |
| Sex: Female, Male Female | 212 Participants | 212 Participants | 212 Participants | 636 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 44 / 212 | 11 / 212 | 26 / 212 |
| serious Total, serious adverse events | 0 / 212 | 0 / 212 | 0 / 212 |
Outcome results
Primary
Intraoperative Blood Loss
Time frame: from start of cesarean section till the end of operation (average one hour)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sublingual Misoprostol & Rectal Placebo | Intraoperative Blood Loss | 357.8 millilitres | Standard Deviation 129.7 |
| Rectal & Sublingual Placebo | Intraoperative Blood Loss | 641.7 millilitres | Standard Deviation 135.7 |
| Rectal Misoprostol & Sublingual Placebo | Intraoperative Blood Loss | 457.5 millilitres | Standard Deviation 140.7 |
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).
Time frame: 1minute and 5 minutes from delivery of the fetus
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Sublingual Misoprostol & Rectal Placebo | APGAR Score | APGAR 1 minute | 6.5 units on a scale | Standard Deviation 0.5 |
| Sublingual Misoprostol & Rectal Placebo | APGAR Score | APGAR 5 minute | 8.5 units on a scale | Standard Deviation 0.5 |
| Rectal & Sublingual Placebo | APGAR Score | APGAR 1 minute | 6.5 units on a scale | Standard Deviation 0.5 |
| Rectal & Sublingual Placebo | APGAR Score | APGAR 5 minute | 8.5 units on a scale | Standard Deviation 0.5 |
| Rectal Misoprostol & Sublingual Placebo | APGAR Score | APGAR 1 minute | 6.5 units on a scale | Standard Deviation 0.5 |
| Rectal Misoprostol & Sublingual Placebo | APGAR Score | APGAR 5 minute | 8.5 units on a scale | Standard Deviation 0.5 |
Secondary
Incidence of Adverse Effects
Time frame: 24 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sublingual Misoprostol & Rectal Placebo | Incidence of Adverse Effects | Fever | 44 no. of cases experiencing side effects |
| Sublingual Misoprostol & Rectal Placebo | Incidence of Adverse Effects | Chills | 42 no. of cases experiencing side effects |
| Rectal & Sublingual Placebo | Incidence of Adverse Effects | Fever | 11 no. of cases experiencing side effects |
| Rectal & Sublingual Placebo | Incidence of Adverse Effects | Chills | 11 no. of cases experiencing side effects |
| Rectal Misoprostol & Sublingual Placebo | Incidence of Adverse Effects | Fever | 26 no. of cases experiencing side effects |
| Rectal Misoprostol & Sublingual Placebo | Incidence of Adverse Effects | Chills | 24 no. of cases experiencing side effects |
Secondary
Incidence of Wound Sepsis
Time frame: upto one week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sublingual Misoprostol & Rectal Placebo | Incidence of Wound Sepsis | 3 no. of cases experiencing wound sepsis |
| Rectal & Sublingual Placebo | Incidence of Wound Sepsis | 5 no. of cases experiencing wound sepsis |
| Rectal Misoprostol & Sublingual Placebo | Incidence of Wound Sepsis | 4 no. of cases experiencing wound sepsis |
Secondary
Need for Extra Analgesics
Time frame: average 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sublingual Misoprostol & Rectal Placebo | Need for Extra Analgesics | 56 participants |
| Rectal & Sublingual Placebo | Need for Extra Analgesics | 62 participants |
| Rectal Misoprostol & Sublingual Placebo | Need for Extra Analgesics | 50 participants |
Secondary
Need for Extra Ecbolics (Oxytocin).
Time frame: from start of cesarean section till the end of operation (average one hour)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sublingual Misoprostol & Rectal Placebo | Need for Extra Ecbolics (Oxytocin). | 209 participants |
| Rectal & Sublingual Placebo | Need for Extra Ecbolics (Oxytocin). | 206 participants |
| Rectal Misoprostol & Sublingual Placebo | Need for Extra Ecbolics (Oxytocin). | 204 participants |
Secondary
Need for Postoperative Blood Transfusion
Time frame: average 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sublingual Misoprostol & Rectal Placebo | Need for Postoperative Blood Transfusion | 4 participants |
| Rectal & Sublingual Placebo | Need for Postoperative Blood Transfusion | 10 participants |
| Rectal Misoprostol & Sublingual Placebo | Need for Postoperative Blood Transfusion | 5 participants |
Secondary
Time to Resume Bowel Habits
Time frame: average 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sublingual Misoprostol & Rectal Placebo | Time to Resume Bowel Habits | 15.1 hours | Standard Deviation 3.1 |
| Rectal & Sublingual Placebo | Time to Resume Bowel Habits | 14.7 hours | Standard Deviation 3.5 |
| Rectal Misoprostol & Sublingual Placebo | Time to Resume Bowel Habits | 14.5 hours | Standard Deviation 3.5 |
Other Pre-specified
Change in Hematocrite Value
Time frame: 24 hours postoperative from baseline hematocrite value
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sublingual Misoprostol & Rectal Placebo | Change in Hematocrite Value | -0.1 Percentage Hematocrit | Standard Deviation 0.8 |
| Rectal & Sublingual Placebo | Change in Hematocrite Value | -1.6 Percentage Hematocrit | Standard Deviation 0.3 |
| Rectal Misoprostol & Sublingual Placebo | Change in Hematocrite Value | -0.1 Percentage Hematocrit | Standard Deviation 0.9 |
Other Pre-specified
Change in Hemoglobin Concentration
Time frame: 24 hours postoperative from baseline hemoglobin
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sublingual Misoprostol & Rectal Placebo | Change in Hemoglobin Concentration | -0.3 gram/dL | Standard Deviation 0.1 |
| Rectal & Sublingual Placebo | Change in Hemoglobin Concentration | -0.9 gram/dL | Standard Deviation 0.1 |
| Rectal Misoprostol & Sublingual Placebo | Change in Hemoglobin Concentration | -0.4 gram/dL | Standard Deviation 0.1 |