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Preoperative and Postoperative Sublingual Misoprostol for Prevention of Postpartum Blood Loss in Cesarean Section

Primary Purpose

Postpartum Hemorrhage

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

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All pregnant women who will undergo elective lower segment cesarean section
  • term ( ≥ 37 weeks)
  • normal fetal heart tracing.

Exclusion Criteria:

  • Placenta previa-Rupture uterus
  • Classical cesarean section
  • Preterm delivery
  • Hypertensive disorders of pregnancy
  • Bleeding tendency
  • Previous history of postpartum hemorrhage
  • Concurrent anticoagulant therapy
  • Concurrent long-term use of steroids
  • Fetal distress
  • Antepartum haemorrhage

Sites / Locations

  • Ahmed Abbas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

study group

control group

Arm Description

will receive sublingual misoprostol immediately after urinary catheterization and before skin incision

will receive sublingual misoprostol immediately after skin closure

Outcomes

Primary Outcome Measures

mean intraoperative blood loss
Blood loss estimation will commence immediately following the skin incision

Secondary Outcome Measures

Full Information

First Posted
July 8, 2018
Last Updated
September 17, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03591913
Brief Title
Preoperative and Postoperative Sublingual Misoprostol for Prevention of Postpartum Blood Loss in Cesarean Section
Official Title
Comparison Between Preoperative and Postoperative Sublingual Misoprostol for Prevention of Postpartum Blood Loss in Cesarean Section : a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
Cesarean section is one of the most common major surgical operations among women. In 2015, the incidence of cesarean section in Woman Health Hospital in Assiut University accounts for 51.3 % of all deliveries

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
will receive sublingual misoprostol immediately after urinary catheterization and before skin incision
Arm Title
control group
Arm Type
Active Comparator
Arm Description
will receive sublingual misoprostol immediately after skin closure
Intervention Type
Drug
Intervention Name(s)
Misoprostol
Intervention Description
Oral tablets
Primary Outcome Measure Information:
Title
mean intraoperative blood loss
Description
Blood loss estimation will commence immediately following the skin incision
Time Frame
24 hours

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All pregnant women who will undergo elective lower segment cesarean section term ( ≥ 37 weeks) normal fetal heart tracing. Exclusion Criteria: Placenta previa-Rupture uterus Classical cesarean section Preterm delivery Hypertensive disorders of pregnancy Bleeding tendency Previous history of postpartum hemorrhage Concurrent anticoagulant therapy Concurrent long-term use of steroids Fetal distress Antepartum haemorrhage
Facility Information:
Facility Name
Ahmed Abbas
City
Assiut
State/Province
Cairo
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

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Preoperative and Postoperative Sublingual Misoprostol for Prevention of Postpartum Blood Loss in Cesarean Section

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