Trial Outcomes & Findings for Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss (NCT NCT02083107)
NCT ID: NCT02083107
Last Updated: 2015-12-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
636 participants
Primary outcome timeframe
from start of cesarean section till the end of operation (average one hour)
Results posted on
2015-12-22
Participant Flow
Participant milestones
| Measure |
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
|
Rectal & Sublingual Placebo
will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
212
|
212
|
212
|
|
Overall Study
COMPLETED
|
212
|
212
|
212
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss
Baseline characteristics by cohort
| Measure |
Sublingual Misoprostol & Rectal Placebo
n=212 Participants
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
|
Rectal & Sublingual Placebo
n=212 Participants
will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".
|
Rectal Misoprostol & Sublingual Placebo
n=212 Participants
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
|
Total
n=636 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
26.9 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
26.4 years
STANDARD_DEVIATION 2.7 • n=7 Participants
|
26.5 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
26.6 years
STANDARD_DEVIATION 2.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
212 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
636 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Body Mass Index (BMI)
|
27.5 Kg/m2
STANDARD_DEVIATION 1.7 • n=5 Participants
|
27.6 Kg/m2
STANDARD_DEVIATION 1.9 • n=7 Participants
|
27.4 Kg/m2
STANDARD_DEVIATION 1.7 • n=5 Participants
|
27.5 Kg/m2
STANDARD_DEVIATION 1.76 • n=4 Participants
|
|
Parity
|
1 Births
n=5 Participants
|
1 Births
n=7 Participants
|
1 Births
n=5 Participants
|
1 Births
n=4 Participants
|
|
Gestational Age
|
38.9 Weeks
STANDARD_DEVIATION 1 • n=5 Participants
|
38.9 Weeks
STANDARD_DEVIATION 0.9 • n=7 Participants
|
38.8 Weeks
STANDARD_DEVIATION 0.9 • n=5 Participants
|
38.8 Weeks
STANDARD_DEVIATION 0.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: from start of cesarean section till the end of operation (average one hour)Outcome measures
| Measure |
Sublingual Misoprostol & Rectal Placebo
n=212 Participants
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
|
Rectal & Sublingual Placebo
n=212 Participants
will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".
|
Rectal Misoprostol & Sublingual Placebo
n=212 Participants
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
|
|---|---|---|---|
|
Intraoperative Blood Loss
|
357.8 millilitres
Standard Deviation 129.7
|
641.7 millilitres
Standard Deviation 135.7
|
457.5 millilitres
Standard Deviation 140.7
|
SECONDARY outcome
Timeframe: from start of cesarean section till the end of operation (average one hour)Outcome measures
| Measure |
Sublingual Misoprostol & Rectal Placebo
n=212 Participants
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
|
Rectal & Sublingual Placebo
n=212 Participants
will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".
|
Rectal Misoprostol & Sublingual Placebo
n=212 Participants
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
|
|---|---|---|---|
|
Need for Extra Ecbolics (Oxytocin).
|
209 participants
|
206 participants
|
204 participants
|
SECONDARY outcome
Timeframe: 1minute and 5 minutes from delivery of the fetusThe 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).
Outcome measures
| Measure |
Sublingual Misoprostol & Rectal Placebo
n=212 Participants
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
|
Rectal & Sublingual Placebo
n=212 Participants
will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".
|
Rectal Misoprostol & Sublingual Placebo
n=212 Participants
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
|
|---|---|---|---|
|
APGAR Score
APGAR 1 minute
|
6.5 units on a scale
Standard Deviation 0.5
|
6.5 units on a scale
Standard Deviation 0.5
|
6.5 units on a scale
Standard Deviation 0.5
|
|
APGAR Score
APGAR 5 minute
|
8.5 units on a scale
Standard Deviation 0.5
|
8.5 units on a scale
Standard Deviation 0.5
|
8.5 units on a scale
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: average 24 hoursOutcome measures
| Measure |
Sublingual Misoprostol & Rectal Placebo
n=212 Participants
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
|
Rectal & Sublingual Placebo
n=212 Participants
will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".
|
Rectal Misoprostol & Sublingual Placebo
n=212 Participants
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
|
|---|---|---|---|
|
Time to Resume Bowel Habits
|
15.1 hours
Standard Deviation 3.1
|
14.7 hours
Standard Deviation 3.5
|
14.5 hours
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: average 24 hoursOutcome measures
| Measure |
Sublingual Misoprostol & Rectal Placebo
n=212 Participants
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
|
Rectal & Sublingual Placebo
n=212 Participants
will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".
|
Rectal Misoprostol & Sublingual Placebo
n=212 Participants
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
|
|---|---|---|---|
|
Need for Extra Analgesics
|
56 participants
|
62 participants
|
50 participants
|
SECONDARY outcome
Timeframe: average 24 hoursOutcome measures
| Measure |
Sublingual Misoprostol & Rectal Placebo
n=212 Participants
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
|
Rectal & Sublingual Placebo
n=212 Participants
will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".
|
Rectal Misoprostol & Sublingual Placebo
n=212 Participants
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
|
|---|---|---|---|
|
Need for Postoperative Blood Transfusion
|
4 participants
|
10 participants
|
5 participants
|
SECONDARY outcome
Timeframe: upto one weekOutcome measures
| Measure |
Sublingual Misoprostol & Rectal Placebo
n=212 Participants
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
|
Rectal & Sublingual Placebo
n=212 Participants
will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".
|
Rectal Misoprostol & Sublingual Placebo
n=212 Participants
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
|
|---|---|---|---|
|
Incidence of Wound Sepsis
|
3 no. of cases experiencing wound sepsis
|
5 no. of cases experiencing wound sepsis
|
4 no. of cases experiencing wound sepsis
|
SECONDARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
Sublingual Misoprostol & Rectal Placebo
n=212 Participants
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
|
Rectal & Sublingual Placebo
n=212 Participants
will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".
|
Rectal Misoprostol & Sublingual Placebo
n=212 Participants
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
|
|---|---|---|---|
|
Incidence of Adverse Effects
Fever
|
44 no. of cases experiencing side effects
|
11 no. of cases experiencing side effects
|
26 no. of cases experiencing side effects
|
|
Incidence of Adverse Effects
Chills
|
42 no. of cases experiencing side effects
|
11 no. of cases experiencing side effects
|
24 no. of cases experiencing side effects
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hours postoperative from baseline hemoglobinOutcome measures
| Measure |
Sublingual Misoprostol & Rectal Placebo
n=212 Participants
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
|
Rectal & Sublingual Placebo
n=212 Participants
will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".
|
Rectal Misoprostol & Sublingual Placebo
n=212 Participants
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
|
|---|---|---|---|
|
Change in Hemoglobin Concentration
|
-0.3 gram/dL
Standard Deviation 0.1
|
-0.9 gram/dL
Standard Deviation 0.1
|
-0.4 gram/dL
Standard Deviation 0.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 hours postoperative from baseline hematocrite valueOutcome measures
| Measure |
Sublingual Misoprostol & Rectal Placebo
n=212 Participants
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
|
Rectal & Sublingual Placebo
n=212 Participants
will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".
|
Rectal Misoprostol & Sublingual Placebo
n=212 Participants
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
|
|---|---|---|---|
|
Change in Hematocrite Value
|
-0.1 Percentage Hematocrit
Standard Deviation 0.8
|
-1.6 Percentage Hematocrit
Standard Deviation 0.3
|
-0.1 Percentage Hematocrit
Standard Deviation 0.9
|
Adverse Events
Sublingual Misoprostol & Rectal Placebo
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Rectal & Sublingual Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Rectal Misoprostol & Sublingual Placebo
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sublingual Misoprostol & Rectal Placebo
n=212 participants at risk
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
|
Rectal & Sublingual Placebo
n=212 participants at risk
will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".
|
Rectal Misoprostol & Sublingual Placebo
n=212 participants at risk
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
|
|---|---|---|---|
|
General disorders
Fever
|
20.8%
44/212 • starting intra-operative till one week postoperative (time of checking the wound)
|
5.2%
11/212 • starting intra-operative till one week postoperative (time of checking the wound)
|
12.3%
26/212 • starting intra-operative till one week postoperative (time of checking the wound)
|
|
Infections and infestations
wound sepsis
|
1.4%
3/212 • starting intra-operative till one week postoperative (time of checking the wound)
|
2.4%
5/212 • starting intra-operative till one week postoperative (time of checking the wound)
|
1.9%
4/212 • starting intra-operative till one week postoperative (time of checking the wound)
|
|
General disorders
Chills
|
19.8%
42/212 • starting intra-operative till one week postoperative (time of checking the wound)
|
5.2%
11/212 • starting intra-operative till one week postoperative (time of checking the wound)
|
11.3%
24/212 • starting intra-operative till one week postoperative (time of checking the wound)
|
Additional Information
Dr. Mohamed S. Sweed, Dr.Mourad M.El-Said, Dr.Amgad E. Abou-Gamrah, Dr.Mohamed M. Abd-El-Hamid
AinShams University
Phone: 01001222047
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place