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NCT03591913 Clinical Trial

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

Postpartum Hemorrhage Clinical Trial

Official title:
Comparison Between Preoperative and Postoperative Sublingual Misoprostol for Prevention of Postpartum Blood Loss in Cesarean Section : a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03591913
Other study ID # MISOCS
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 1, 2018
Est. completion date September 1, 2018

Study information
Verified date September 2018
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date September 1, 2018
Est. primary completion date August 1, 2018
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Misoprostol
Oral tablets

Locations
Country Name City State
Egypt Ahmed Abbas Assiut Cairo

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary mean intraoperative blood loss Blood loss estimation will commence immediately following the skin incision 24 hours
See also
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Completed NCT02079558 - Efficacy of Oxytocin vs. Carbetocin in Prevention of Postpartum Hemorrhage After Cesarean Section Phase 2
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Terminated NCT03246919 - Ideal Time of Oxytocin Infusion During Cesarean Section Phase 4
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Completed NCT05429580 - Prophylactic Tranexamic Acid Use After Vaginal Delivery N/A
Terminated NCT03064152 - Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery N/A
Recruiting NCT05382403 - Novel Vacuum-Induced Hemorrhage Control for Postpartum Hemorrhage N/A
Not yet recruiting NCT02853552 - Misoprostol as First Aid Measure to Address Excessive Postpartum Bleeding Phase 4
Completed NCT03344302 - Oxytocin Administration During Cesarean Section Phase 4
Completed NCT02805426 - Effectiveness of Tranexamic Acid When Used as an Adjunct to Misoprostol for the Treatment of Postpartum Hemorrhage Phase 4