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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03591913
Recruitment Status : Completed
First Posted : July 19, 2018
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohamed Abbas, Assiut University

Study Description
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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

Condition or disease Intervention/treatment Phase
Postpartum Hemorrhage Drug: Misoprostol Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Comparison Between Preoperative and Postoperative Sublingual Misoprostol for Prevention of Postpartum Blood Loss in Cesarean Section : a Randomized Clinical Trial
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arms and Interventions
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Arm Intervention/treatment
Experimental: study group
will receive sublingual misoprostol immediately after urinary catheterization and before skin incision
 Drug: Misoprostol
Oral tablets
Active Comparator: control group
will receive sublingual misoprostol immediately after skin closure
 Drug: Misoprostol
Oral tablets


Outcome Measures
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Primary Outcome Measures :
  1. mean intraoperative blood loss [ Time Frame: 24 hours ]
    Blood loss estimation will commence immediately following the skin incision


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03591913


Locations
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Egypt
Ahmed Abbas
Assiut, Cairo, Egypt, 002
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Ahmed Mohamed Abbas, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03591913    
Other Study ID Numbers: MISOCS
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Misoprostol
 Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics