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Clinical Trials/NCT03680339
NCT03680339
Completed
Phase 4

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

Cairo University1 site in 1 country200 target enrollmentSeptember 2, 2018

Overview

Phase
Phase 4
Intervention
cesarean section
Conditions
Post Partum Hemorrhage
Sponsor
Cairo University
Enrollment
200
Locations
1
Primary Endpoint
postpartum hemorrhage
Status
Completed
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 2, 2018
End Date
January 28, 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmed M Maged, MD

professor

Cairo University

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
  • Oligo or polyhydraminos by U/S

Arms & Interventions

Routine ecbolic group

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

Intervention: cesarean section

Routine ecbolic group

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

Intervention: Oxytocin

Misoprostol group

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: cesarean section

Misoprostol group

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: Misoprostol

Misoprostol group

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: Oxytocin

Outcomes

Primary Outcomes

postpartum hemorrhage

Time Frame: 24 hours after cesarean section

Study Sites (1)

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