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Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Misoprostol
Placebo
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage focused on measuring Postpartum hemorrhage, Intrapartum blood loss, Misoprostol

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Ain Shams University Maternity Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

sublingual misoprostol & rectal placebo

rectal & sublingual placebo

rectal misoprostol & sublingual placebo

Arm Description

will receive 400 microgram of misoprostol (Sigma) sublingual "2 tablets" and rectal placebo"2 tablets".

will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".

will receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets".

Outcomes

Primary Outcome Measures

Intraoperative Blood Loss

Secondary Outcome Measures

Need for Extra Ecbolics (Oxytocin).
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 to Resume Bowel Habits
Need for Extra Analgesics
Need for Postoperative Blood Transfusion
Incidence of Wound Sepsis
Incidence of Adverse Effects

Full Information

First Posted
March 7, 2014
Last Updated
November 22, 2015
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT02083107
Brief Title
Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss
Official Title
COMPARISON BETWEEN RECTAL & SUBLINGUAL MISOPROSTOL BEFORE CAESARIAN SECTION TO REDUCE INTRA & POST-OPERATIVE BLOOD LOSS
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Postpartum hemorrhage, Intrapartum blood loss, Misoprostol

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
636 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sublingual misoprostol & rectal placebo
Arm Type
Experimental
Arm Description
will receive 400 microgram of misoprostol (Sigma) sublingual "2 tablets" and rectal placebo"2 tablets".
Arm Title
rectal & sublingual placebo
Arm Type
Placebo Comparator
Arm Description
will receive rectal placebo"2 tablets" and sublingual placebo"2 tablets".
Arm Title
rectal misoprostol & sublingual placebo
Arm Type
Experimental
Arm Description
will receive 400 microgram of misoprostol (Sigma) rectal "2 tablets" and sublingual placebo"2 tablets".
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Misotac, Cytotec
Intervention Description
Comparison of different routes of administration of 400 micro gram misoprostol
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Intraoperative Blood Loss
Time Frame
from start of cesarean section till the end of operation (average one hour)
Secondary Outcome Measure Information:
Title
Need for Extra Ecbolics (Oxytocin).
Time Frame
from start of cesarean section till the end of operation (average one hour)
Title
APGAR Score
Description
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
Title
Time to Resume Bowel Habits
Time Frame
average 24 hours
Title
Need for Extra Analgesics
Time Frame
average 24 hours
Title
Need for Postoperative Blood Transfusion
Time Frame
average 24 hours
Title
Incidence of Wound Sepsis
Time Frame
upto one week
Title
Incidence of Adverse Effects
Time Frame
24 hours
Other Pre-specified Outcome Measures:
Title
Change in Hemoglobin Concentration
Time Frame
24 hours postoperative from baseline hemoglobin
Title
Change in Hematocrite Value
Time Frame
24 hours postoperative from baseline hematocrite value

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients booked for elective cesarean section. Singleton pregnancies. 3- Full term pregnancies (GA 37-42 weeks). 4- Patients with only previous one cesarian section Exclusion Criteria: Primigravida. Blood dyscrasias. Large fibroids. Multiple pregnancies. Overdistended uterus eg. Hydramnios. Pre-eclampsia. Marked maternal anemia (Preoperative hemoglobin < 9 gm/dl). Previous history of PPH. Contraindications to prostaglandin therapy (e.g. history of severe bronchial asthma or allergy to misoprostol. Placenta previa. Contraindication to spinal anesthesia. Previous myomectomy. Previous two or more C.S.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed S. Sweed, MD
Organizational Affiliation
Ain Shams University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mourad M. El-Said, Professor
Organizational Affiliation
AinShams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Amgad E. Abou-Gamrah, Ass.Prof.
Organizational Affiliation
AinShams university
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Haitham El-Sabe, MD
Organizational Affiliation
AinShams University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed M. AbdEl-Hamid, Registrar
Organizational Affiliation
AinShams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ain Shams University Maternity Hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss

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