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The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS

Primary Purpose

Post Partum Hemorrhage

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
cesarean section
Misoprostol
Oxytocin
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Partum Hemorrhage

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

women attending for elective CS.

  • Age between 20-35 years.
  • Normal placental site
  • Normal coagulation profile
  • Full term pregnancies(above 37 wks)
  • Medically free
  • Spinal anesthesia
  • Living baby
  • Average liquor by U/S

Exclusion Criteria:

  • • Women attending for emergency CS

    • .age below 20 or above 35
    • Abnormal placentation (Placenta previa,accrete,increta or percreta)
    • Women with coagulopathy
    • Preterm pregnancies (before 37 wks)
    • Medical disorder (Hypertension,Diabetes, Endocrinal disorder)
    • General anathesia
    • IUFD
    • Oligo or polyhydraminos by U/S

Sites / Locations

  • Kasr Alainy medical school

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Routine ecbolic group

Misoprostol group

Arm Description

100 patients will receive routine ecbolics ( oxytocin) after delivery of baby

The 100 patients will receive routine ecbolics (oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen

Outcomes

Primary Outcome Measures

postpartum hemorrhage

Secondary Outcome Measures

Full Information

First Posted
September 19, 2018
Last Updated
June 24, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03680339
Brief Title
The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS
Official Title
The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 2, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 28, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
• Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen Then we will compare between two groups regarding Intaoperative blood loss Risk of Postpartum hemorraghe in the first 24 hrs HB pre and postoperative for all patients Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit
Detailed Description
• Patients will be divided into two groups 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen Then we will compare between two groups regarding Intaoperative blood loss Risk of Postpartum hemorraghe in the first 24 hrs HB pre and postoperative for all patients Intraoperative blood loss will be estimated by the number and weight of soaked towels and amount of blood in suction unit

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Hemorrhage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine ecbolic group
Arm Type
Active Comparator
Arm Description
100 patients will receive routine ecbolics ( oxytocin) after delivery of baby
Arm Title
Misoprostol group
Arm Type
Active Comparator
Arm Description
The 100 patients will receive routine ecbolics (oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen
Intervention Type
Procedure
Intervention Name(s)
cesarean section
Intervention Description
CS will be done by pfannenstiel incision , transverse lower uterine segment incision ,immediate cord clamping after delivery of baby , closure of uterus by 2 layers , closure of abdomen in layers
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Other Intervention Name(s)
Cytotec
Intervention Description
The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Intervention Description
10 IU of oxytocin with fetal delivery
Primary Outcome Measure Information:
Title
postpartum hemorrhage
Time Frame
24 hours after cesarean section

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women attending for elective CS. Age between 20-35 years. Normal placental site Normal coagulation profile Full term pregnancies(above 37 wks) Medically free Spinal anesthesia Living baby Average liquor by U/S Exclusion Criteria: • Women attending for emergency CS .age below 20 or above 35 Abnormal placentation (Placenta previa,accrete,increta or percreta) Women with coagulopathy Preterm pregnancies (before 37 wks) Medical disorder (Hypertension,Diabetes, Endocrinal disorder) General anathesia IUFD Oligo or polyhydraminos by U/S
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed maged, MD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kasr Alainy medical school
City
Cairo
ZIP/Postal Code
12111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31304593
Citation
Maged AM, Fawzi T, Shalaby MA, Samy A, Rabee MA, Ali AS, Hussein EA, Hammad B, Deeb WS. A randomized controlled trial of the safety and efficacy of preoperative rectal misoprostol for prevention of intraoperative and postoperative blood loss at elective cesarean delivery. Int J Gynaecol Obstet. 2019 Oct;147(1):102-107. doi: 10.1002/ijgo.12922. Epub 2019 Jul 25.
Results Reference
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The Effect of Preoperative and Post Operative Misoprostol Administration on Intraoperative Blood Loss and Postpartum Hemorrhage in CS

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