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

Overview

• 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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 1, 2019

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

Interventions

  • Procedure: cesarean section
    • 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
  • Drug: Misoprostol
    • 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
  • Drug: Oxytocin
    • 10 IU of oxytocin with fetal delivery

Arms, Groups and Cohorts

  • Active Comparator: Routine ecbolic group
    • 100 patients will receive routine ecbolics ( oxytocin) after delivery of baby
  • Active Comparator: 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

Clinical Trial Outcome Measures

Primary Measures

  • postpartum hemorrhage
    • Time Frame: 24 hours after cesarean section

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ahmed M Maged, MD, professor – Cairo University
  • Overall Official(s)
    • Ahmed maged, MD, Principal Investigator, Professor

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