Trial · NCT02083107
Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss
NCT02083107, Phase 2, Phase 3, Completed, Ain Shams University; results first posted 2014-06-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss. Trials, record NCT02083107. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02083107
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss
- NCT number
- NCT02083107
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 636 participants, actual
- Lead sponsor
- Ain Shams University
- Conditions
- Postpartum Hemorrhage
- Interventions
- Misoprostol, Placebo
- First posted
- 2014-03-11
- Last updated
- 2015-12-22
- Results first posted
- 2014-06-27
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intraoperative Blood Loss | from start of cesarean section till the end of operation (average one hour) | |
| Secondary | Need for Extra Ecbolics (Oxytocin). | from start of cesarean section till the end of operation (average one hour) | |
| Secondary | 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). |
| Secondary | Time to Resume Bowel Habits | average 24 hours | |
| Secondary | Need for Extra Analgesics | average 24 hours | |
| Secondary | Need for Postoperative Blood Transfusion | average 24 hours | |
| Secondary | Incidence of Wound Sepsis | upto one week | |
| Secondary | Incidence of Adverse Effects | 24 hours | |
| Other | Change in Hemoglobin Concentration | 24 hours postoperative from baseline hemoglobin | |
| Other | Change in Hematocrite Value | 24 hours postoperative from baseline hematocrite value |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Intraoperative Blood Loss | from start of cesarean section till the end of operation (average one hour) | millilitres | MEAN | |
| SECONDARY | Need for Extra Ecbolics (Oxytocin). | from start of cesarean section till the end of operation (average one hour) | participants | NUMBER | |
| OTHER_PRE_SPECIFIED | Change in Hemoglobin Concentration | 24 hours postoperative from baseline hemoglobin | gram/dL | MEAN | |
| SECONDARY | APGAR Score | 1minute and 5 minutes from delivery of the fetus | units on a scale | MEAN | |
| SECONDARY | Time to Resume Bowel Habits | average 24 hours | hours | MEAN | |
| SECONDARY | Need for Extra Analgesics | average 24 hours | participants | NUMBER | |
| SECONDARY | Need for Postoperative Blood Transfusion | average 24 hours | participants | NUMBER | |
| SECONDARY | Incidence of Wound Sepsis | upto one week | no. of cases experiencing wound sepsis | NUMBER | |
| SECONDARY | Incidence of Adverse Effects | 24 hours | no. of cases experiencing side effects | NUMBER | |
| OTHER_PRE_SPECIFIED | Change in Hematocrite Value | 24 hours postoperative from baseline hematocrite value | Percentage Hematocrit | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Intraoperative Blood Loss | Sublingual Misoprostol & Rectal Placebo | 357.8 | Standard Deviation 129.7 | millilitres | |
| Intraoperative Blood Loss | Rectal & Sublingual Placebo | 641.7 | Standard Deviation 135.7 | millilitres | |
| Intraoperative Blood Loss | Rectal Misoprostol & Sublingual Placebo | 457.5 | Standard Deviation 140.7 | millilitres | |
| Need for Extra Ecbolics (Oxytocin). | Sublingual Misoprostol & Rectal Placebo | 209 | participants | ||
| Need for Extra Ecbolics (Oxytocin). | Rectal & Sublingual Placebo | 206 | participants | ||
| Need for Extra Ecbolics (Oxytocin). | Rectal Misoprostol & Sublingual Placebo | 204 | participants | ||
| Change in Hemoglobin Concentration | Sublingual Misoprostol & Rectal Placebo | -0.3 | Standard Deviation 0.1 | gram/dL | |
| Change in Hemoglobin Concentration | Rectal & Sublingual Placebo | -0.9 | Standard Deviation 0.1 | gram/dL | |
| Change in Hemoglobin Concentration | Rectal Misoprostol & Sublingual Placebo | -0.4 | Standard Deviation 0.1 | gram/dL | |
| APGAR Score | Sublingual Misoprostol & Rectal Placebo | APGAR 1 minute | 6.5 | Standard Deviation 0.5 | units on a scale |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sublingual Misoprostol & Rectal Placebo | 212 | |
| Overall Study | STARTED | Rectal & Sublingual Placebo | 212 | |
| Overall Study | STARTED | Rectal Misoprostol & Sublingual Placebo | 212 | |
| Overall Study | COMPLETED | Sublingual Misoprostol & Rectal Placebo | 212 | |
| Overall Study | COMPLETED | Rectal & Sublingual Placebo | 212 | |
| Overall Study | COMPLETED | Rectal Misoprostol & Sublingual Placebo | 212 | |
| Overall Study | NOT COMPLETED | Sublingual Misoprostol & Rectal Placebo | 0 | |
| Overall Study | NOT COMPLETED | Rectal & Sublingual Placebo | 0 | |
| Overall Study | NOT COMPLETED | Rectal Misoprostol & Sublingual Placebo | 0 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Fever | General disorders | Sublingual Misoprostol & Rectal Placebo | 44 | 212 | |
| other | Fever | General disorders | Rectal & Sublingual Placebo | 11 | 212 | |
| other | Fever | General disorders | Rectal Misoprostol & Sublingual Placebo | 26 | 212 | |
| other | wound sepsis | Infections and infestations | Sublingual Misoprostol & Rectal Placebo | 3 | 212 | |
| other | wound sepsis | Infections and infestations | Rectal & Sublingual Placebo | 5 | 212 | |
| other | wound sepsis | Infections and infestations | Rectal Misoprostol & Sublingual Placebo | 4 | 212 | |
| other | Chills | General disorders | Sublingual Misoprostol & Rectal Placebo | 42 | 212 | |
| other | Chills | General disorders | Rectal & Sublingual Placebo | 11 | 212 | |
| other | Chills | General disorders | Rectal Misoprostol & Sublingual Placebo | 24 | 212 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sublingual Misoprostol & Rectal Placebo | ||
| Total, all-cause mortality | Rectal & Sublingual Placebo | ||
| Total, all-cause mortality | Rectal Misoprostol & Sublingual Placebo | ||
| Total, other adverse events | Sublingual Misoprostol & Rectal Placebo | 44 | 212 |
| Total, other adverse events | Rectal & Sublingual Placebo | 11 | 212 |
| Total, other adverse events | Rectal Misoprostol & Sublingual Placebo | 26 | 212 |
| Total, serious adverse events | Sublingual Misoprostol & Rectal Placebo | 0 | 212 |
| Total, serious adverse events | Rectal & Sublingual Placebo | 0 | 212 |
| Total, serious adverse events | Rectal Misoprostol & Sublingual Placebo | 0 | 212 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02083107
GET https://conductscience.org/api/trials/v1/NCT02083107/results?page=2